DiabetesPhase 3LEAD-6NCT00518882
Effect of Liraglutide or Exenatide Added to an Ongoing Treatment on Blood Glucose Control in Subjects With Type 2 Diabetes
A Phase 3 study testing liraglutide and exenatide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 125 sites in 16 countries.
Trial summary
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea or a combination of both in subjects with… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- liraglutide and exenatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 467 participants
- Where
- 125 sitesin 16 countries
- Study dates
- Aug 2007to Apr 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- Stable treatment with Oral Anti-Diabetic Drugs (metformin, sulphonylurea or a combination of both) for at least 3 months at the discretion of the Investigator
- HbA1C equal to or greater than 7.0% and equal to or lower than 11.0%
- Body Mass Index (BMI) equal to or lower than 45.0 kg/m2
Who cannot join
- Previous treatment with insulin
- Treatment with any anti-diabetic drug other than metformin and sulphonylurea
- Any previous exposure to exenatide or liraglutide
- Impaired liver or/and renal function
- History of any significant cardiac events
- Known retinopathy or maculopathy requiring acute treatment
- Recurrent major hypoglycaemia or hypoglycaemic unawareness
Trial locations and contacts
125 sites in 16 countries.
125 sites in 16 countries
United States61 sites
Novo Nordisk Investigational Site
Altoona, Pennsylvania, 16602
Novo Nordisk Investigational Site
Artesia, California, 90701
Novo Nordisk Investigational Site
Atlanta, Georgia, 30318
Novo Nordisk Investigational Site
Austin, Texas, 78731
Novo Nordisk Investigational Site
Birmingham, Alabama, 35242
Novo Nordisk Investigational Site
Canton, Ohio, 44718
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, 27517
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37404
Novo Nordisk Investigational Site
Chicago, Illinois, 60616
Novo Nordisk Investigational Site
Cincinnati, Ohio, 45206
Novo Nordisk Investigational Site
City of Saint Peters, Missouri, 63376
Novo Nordisk Investigational Site
Corpus Christi, Texas, 78412
Novo Nordisk Investigational Site
Dallas, Texas, 75230
Novo Nordisk Investigational Site
Dallas, Texas, 75231
Novo Nordisk Investigational Site
Dallas, Texas, 75246
Novo Nordisk Investigational Site
Dayton, Ohio, 45439
Novo Nordisk Investigational Site
Des Moines, Iowa, 50314-3027
Novo Nordisk Investigational Site
Encino, California, 91436
Novo Nordisk Investigational Site
Escondido, California, 92025
Novo Nordisk Investigational Site
Evansville, Indiana, 47714
Novo Nordisk Investigational Site
Flemington, New Jersey, 08822
Novo Nordisk Investigational Site
Fort Myers, Florida, 33907
Novo Nordisk Investigational Site
Goodyear, Arizona, 85395
Novo Nordisk Investigational Site
Hollywood, Florida, 33023
Novo Nordisk Investigational Site
Houston, Texas, 77030
Novo Nordisk Investigational Site
Idaho Falls, Idaho, 83404-7596
Novo Nordisk Investigational Site
Jacksonville, Florida, 32205
Novo Nordisk Investigational Site
Jacksonville, Florida, 32216
Novo Nordisk Investigational Site
Jacksonville, Florida, 32259
Novo Nordisk Investigational Site
Kettering, Ohio, 45429
Novo Nordisk Investigational Site
Longwood, Florida, 32779
Novo Nordisk Investigational Site
Los Angeles, California, 90057
Novo Nordisk Investigational Site
Mentor, Ohio, 44060
Novo Nordisk Investigational Site
Midland, Texas, 79707
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, 53209
Novo Nordisk Investigational Site
Minneapolis, Minnesota, 55416
Novo Nordisk Investigational Site
New Orleans, Louisiana, 70121
Novo Nordisk Investigational Site
Newport News, Virginia, 23606
Novo Nordisk Investigational Site
Northport, New York, 11768
Novo Nordisk Investigational Site
Ocala, Florida, 34471
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, 73103
Novo Nordisk Investigational Site
Olympia, Washington, 98502
Novo Nordisk Investigational Site
Orange, California, 92869
Novo Nordisk Investigational Site
Pembroke Pines, Florida, 33029
Novo Nordisk Investigational Site
Peoria, Illinois, 61615
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19152
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, 15213
Novo Nordisk Investigational Site
Plantation, Florida, 33324
Novo Nordisk Investigational Site
Powder Springs, Georgia, 30127
Novo Nordisk Investigational Site
Richmond, Virginia, 23294
Novo Nordisk Investigational Site
Roswell, Georgia, 30076
Novo Nordisk Investigational Site
Sacramento, California, 95816
Novo Nordisk Investigational Site
Saint Cloud, Florida, 34769
Novo Nordisk Investigational Site
Saint Paul, Minnesota, 55108
Novo Nordisk Investigational Site
San Antonio, Texas, 78229
Novo Nordisk Investigational Site
San Mateo, California, 94401
Novo Nordisk Investigational Site
South Bound Brook, New Jersey, 08880
Novo Nordisk Investigational Site
Spokane, Washington, 99218
Novo Nordisk Investigational Site
Spring Valley, California, 91978
Novo Nordisk Investigational Site
Sumter, South Carolina, 29150
Novo Nordisk Investigational Site
Walnut Creek, California, 94598
Germany14 sites
Novo Nordisk Investigational Site
Bochum, 44791
Novo Nordisk Investigational Site
Dreieich-Sprendlingen, 63303
Novo Nordisk Investigational Site
Falkensee, 14612
Novo Nordisk Investigational Site
Frankfurt, 60388
Novo Nordisk Investigational Site
Hamburg, 22607
Novo Nordisk Investigational Site
Hanover, 30625
Novo Nordisk Investigational Site
Herrenberg, 71083
Novo Nordisk Investigational Site
Lampertheim, 68623
Novo Nordisk Investigational Site
Ludwigshafen, 67059
Novo Nordisk Investigational Site
Marburg, 35039
Novo Nordisk Investigational Site
Pohlheim, 35415
Novo Nordisk Investigational Site
Rehlingen-Siersburg, 66780
Novo Nordisk Investigational Site
Speyer, 67346
Novo Nordisk Investigational Site
Tübingen, 72072
Poland9 sites
Novo Nordisk Investigational Site
Bydgoszcz, 85-822
Novo Nordisk Investigational Site
Gniewkowo, 88-140
Novo Nordisk Investigational Site
Krakow, 31-501
Novo Nordisk Investigational Site
Lublin, 20-081
Novo Nordisk Investigational Site
Poznan, 60-821
Novo Nordisk Investigational Site
Tychy, 43-100
Novo Nordisk Investigational Site
Warsaw, 01-911
Novo Nordisk Investigational Site
Wroclaw, 50-127
Novo Nordisk Investigational Site
Zabrze, 41-800
Denmark5 sites
Novo Nordisk Investigational Site
Aalborg, 9000
Novo Nordisk Investigational Site
Århus C, 8000
Novo Nordisk Investigational Site
Gentofte Municipality, 2820
Novo Nordisk Investigational Site
Hvidovre, 2650
Novo Nordisk Investigational Site
Odense, 5000
France5 sites
Novo Nordisk Investigational Site
Antibes, 06600
Novo Nordisk Investigational Site
Dommartin-lès-Toul, 54201
Novo Nordisk Investigational Site
La Rochelle, 17019
Novo Nordisk Investigational Site
Narbonne, 11108
Novo Nordisk Investigational Site
Nevers, 58033
Norway4 sites
Novo Nordisk Investigational Site
Bergen, 5021
Novo Nordisk Investigational Site
Bergen, NO-5012
Novo Nordisk Investigational Site
Stavanger, 4011
Novo Nordisk Investigational Site
Trondheim, NO-7030
Spain4 sites
Novo Nordisk Investigational Site
L'Hospitalet de Llobregat, 08907
Novo Nordisk Investigational Site
Oviedo, 33006
Novo Nordisk Investigational Site
Palma de Mallorca, 07010
Novo Nordisk Investigational Site
Puerto del Rosario, 35600
Switzerland4 sites
Novo Nordisk Investigational Site
Basel, 4031
Novo Nordisk Investigational Site
Bern, 3010
Novo Nordisk Investigational Site
Geneva, 1211
Novo Nordisk Investigational Site
Lugano, 6900
Austria3 sites
Novo Nordisk Investigational Site
Graz, 8036
Novo Nordisk Investigational Site
Vienna, 1030
Novo Nordisk Investigational Site
Vienna, 1130
Finland3 sites
Novo Nordisk Investigational Site
Helsinki, 00029
Novo Nordisk Investigational Site
Lahti, 15110
Novo Nordisk Investigational Site
Oulu, FI-90100
Ireland3 sites
Novo Nordisk Investigational Site
Dublin, DUBLIN 7
Novo Nordisk Investigational Site
Dublin, DUBLIN 8
Novo Nordisk Investigational Site
Dublin
Romania3 sites
Novo Nordisk Investigational Site
Alba Iulia, Alba, 510053
Novo Nordisk Investigational Site
Reşiţa, 320076
Novo Nordisk Investigational Site
Suceava, Suceava, 720237
Slovenia3 sites
Novo Nordisk Investigational Site
Koper, SI-6000
Novo Nordisk Investigational Site
Ljubljana, 1525
Novo Nordisk Investigational Site
Novo Mesto, 8000
Sweden2 sites
Novo Nordisk Investigational Site
Stockholm, 141 86
Novo Nordisk Investigational Site
Stockholm, 171 76
About this study
Official title: Effect of Liraglutide or Exenatide Added to a Background Treatment of Metformin, Sulphonylurea or a Combination of Both on Glycaemic Control in Subjects With Type 2 Diabetes
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea or a combination of both in subjects with type 2 diabetes. Two trial periods: A 26 week randomised, followed by a 52 week extension (14 + 38 weeks) where all subjects received liraglutide + OAD after previous randomisation to either liraglutide or exenatide, both combined with OAD treatment.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- liraglutide, exenatide
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liraglutideDrug
1.8 mg once daily for s.c. (under the skin) injection.
exenatideDrug
10 mcg twice daily for s.c. (under the skin) injection.
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Experimental | Liraglutide 1.8 mg once daily + subject's own OAD treatment Receives: Drug: liraglutide |
| Exenatide | Active comparator | Exenatide 10 mcg twice daily + subject's own OAD treatment Receives: Drug: exenatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycosylated A1c (HbA1c) at Week 26
Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation)
Measured: week 0, week 26
Secondary outcomes (54)
Change in Glycosylated A1c (HbA1c), Weeks 26-78
Percentage point change in glycosylated A1c (HbA1c) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)
Measured: week 26, week 78
Change in Glycosylated A1c (HbA1c) at Week 78
Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)
Measured: week 0, week 78
Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26
Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 26 (end of randomisation)
Measured: week 0, week 26
Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78
Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 78 (end of treatment)
Measured: week 0, week 78
Change in Body Weight at Week 26
Change in body weight from baseline (week 0) to 26 weeks (end of randomisation)
Measured: week 0, week 26
Change in Body Weight, Weeks 26-78
Change in body weight from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)
Measured: week 26, week 78
Change in Body Weight at Week 78
Change in body weight from baseline (Week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)
Measured: week 0, week 78
Change in Fasting Plasma Glucose at Week 26
Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation)
Measured: week 0, week 26
Change in Fasting Plasma Glucose, Weeks 26-78
Change in fasting plasma glucose from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)
Measured: week 26, week 78
Change in Fasting Plasma Glucose at Week 78
Change in fasting plasma glucose from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)
Measured: week 0, week 78
Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26
Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after breakfast.
Measured: week 0, week 26
Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26
Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.
Measured: week 0, week 26
Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 26
Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.
Measured: week 0, week 26
Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78
Change in mean prandial increment of plasma glucose after breakfast from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.
Measured: week 26, week 78
Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78
Change in mean prandial increment of plasma glucose after lunch from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after a lunch.
Measured: week 26, week 78
Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78
Change in mean prandial increment of plasma glucose after dinner from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.
Measured: week 26, week 78
Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78
Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.
Measured: week 0, week 78
Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78
Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.
Measured: week 0, week 78
Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78
Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.
Measured: week 0, week 78
Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 26
Change in mean postprandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.
Measured: week 0, week 26
Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 26
Change in mean postprandial increment of plasma glucose after lunch from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.
Measured: week 0. week 26
Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 26
Change in mean postprandial increment of plasma glucose after dinner from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.
Measured: week 0, week 26
Change in Mean Postprandial Increment of Plasma Glucose After Breakfast, Weeks 26-78
Change in mean postprandial increment of plasma glucose after breakfast from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.
Measured: week 26, week 78
Change in Mean Postprandial Increment of Plasma Glucose After Lunch, Weeks 26-78
Change in mean postprandial increment of plasma glucose after lunch from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.
Measured: week 26, week 78
Change in Mean Postprandial Increment of Plasma Glucose After Dinner, Weeks 26-78
Change in mean postprandial increment of plasma glucose after dinner from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.
Measured: week 26, week 78
Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 78
Change in mean postprandial increment of plasma glucose after breakfast from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.
Measured: week 0, week 78
Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 78
Change in mean postprandial increment of plasma glucose after lunch from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.
Measured: week 0, week 78
Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78
Change in mean postprandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.
Measured: week 0, week 78
Change in Beta-cell Function at Week 26
Change in Beta-cell function from baseline (week 0) to 26 weeks (end of randomisation). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5).
Measured: week 0, week 26
Change in Beta-cell Function, Weeks 26-78
Change in Beta-cell function from Week 26 (end of randomisation) to Week 78 (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5).
Measured: week 26, week 78
Change in Beta-cell Function at Week 78
Change in Beta-cell function from baseline (week 0) to 78 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5).
Measured: week 0, week 78
Change in Total Cholesterol at Week 26
Change in total cholesterol (TC) from baseline (week 0) to 26 weeks (end of randomisation)
Measured: week 0, week 26
Change in Total Cholesterol, Weeks 26-78
Change in total cholesterol (TC) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
Measured: week 26, week 78
Change in Total Cholesterol at Week 78
Change in total cholesterol (TC) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
Measured: week 0, week 78
Change in Low-density Lipoprotein-cholesterol at Week 26
Change in Low-density Lipoprotein-cholesterol (LDL-C) from baseline (week 0) to 26 weeks (end of randomisation)
Measured: week 0, week 26
Change in Low-density Lipoprotein-cholesterol, Weeks 26-78
Change in low-density lipoprotein-cholesterol (LDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
Measured: week 26, week 78
Change in Low-density Lipoprotein-cholesterol at Week 78
Change in Low-density Lipoprotein-cholesterol (LDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
Measured: week 0, week 78
Change in Very Low-density Lipoprotein-cholesterol at Week 26
Change in very low-density lipoprotein-cholesterol (VLDL-C) from baseline (week 0) to 26 weeks (end of randomisation)
Measured: week 0, week 26
Change in Very Low-density Lipoprotein-cholesterol, Weeks 26-78
Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
Measured: week 26, week 78
Change in Very Low-density Lipoprotein-cholesterol at Week 78
Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
Measured: week 0, week 78
Change in High-density Lipoprotein-cholesterol at Week 26
Change in High-density Lipoprotein-cholesterol (HDL-C) from baseline (week 0) to 26 weeks (end of randomisation)
Measured: week 0, week 26
Change in High-density Lipoprotein-cholesterol, Weeks 26-78
Change in High-density Lipoprotein-cholesterol (HDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
Measured: week 26, week 78
Change in High-density Lipoprotein-cholesterol at Week 78
Change in High-density Lipoprotein-cholesterol (HDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
Measured: week 0, week 78
Change in Triglyceride at Week 26
Change in triglyceride (TG) from from baseline (week 0) to 26 weeks (end of randomisation)
Measured: week 0, week 26
Change in Triglyceride, Weeks 26-78
Change in Triglyceride (TG) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
Measured: week 26, week 78
Change in Triglyceride at Week 78
Change in triglyceride (TG) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
Measured: week 0, week 78
Change in Free Fatty Acid at Week 26
Change in Free Fatty Acid (FFA) from baseline (week 0) to 26 weeks (end of randomisation)
Measured: week 0, week 26
Change in Free Fatty Acid, Weeks 26-78
Change in Free Fatty Acid (FFA) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
Measured: week 26, week 78
Change in Free Fatty Acid at Week 78
Change in Free Fatty Acid (FFA) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
Measured: week 0, week 78
Change in Apolipoprotein B at Week 26
Change in apolipoprotein B (ApoB) from baseline (week 0) to 26 weeks (end of randomisation)
Measured: week 0, week 26
Change in Apolipoprotein B, Weeks 26-78
Change in apolipoprotein B (ApoB) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
Measured: week 26, week 78
Change in Apolipoprotein B at Week 78
Change in apolipoprotein B (ApoB) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
Measured: week 0, week 78
Hypoglycaemic Episodes at Week 26
Total number of hypoglycaemic episodes occurring after baseline (week 0) and until week 26 (end of randomisation). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Measured: weeks 0-26
Hypoglyceamic Episodes, Weeks 26-78
Total number of hypoglycaemic episodes occurring after end of randomisation (week 26) and until week 78 (end of treatment). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Measured: weeks 26-78
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionApr 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 467 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518882
- Sponsor's protocol ID
- NN2211-1797
- Other IDs
- 2006-006092-21
- Acronym
- LEAD-6
- Status last verified
- Jan 2017
- First submitted
- 20 Aug 2007
- Last updated
- 8 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sullivan SD, Alfonso-Cristancho R, Conner C, Hammer M, Blonde L. Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone. Cardiovasc Diabetol. 2009 Feb 26;8:12. doi: 10.1186/1475-2840-8-12.
PubMed 19245711McGill JB. Insights from the Liraglutide Clinical Development Program--the Liraglutide Effect and Action in Diabetes (LEAD) studies. Postgrad Med. 2009 May;121(3):16-25. doi: 10.3810/pgm.2009.05.1998.
PubMed 19491536Buse JB, Rosenstock J, Sesti G, Schmidt WE, Montanya E, Brett JH, Zychma M, Blonde L; LEAD-6 Study Group. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6). Lancet. 2009 Jul 4;374(9683):39-47. doi: 10.1016/S0140-6736(09)60659-0. Epub 2009 Jun 8.
PubMed 19515413Buse JB, Sesti G, Schmidt WE, Montanya E, Chang CT, Xu Y, Blonde L, Rosenstock J; Liraglutide Effect Action in Diabetes-6 Study Group. Switching to once-daily liraglutide from twice-daily exenatide further improves glycemic control in patients with type 2 diabetes using oral agents. Diabetes Care. 2010 Jun;33(6):1300-3. doi: 10.2337/dc09-2260. Epub 2010 Mar 23.
PubMed 20332351Schmidt WE, Christiansen JS, Hammer M, Zychma MJ, Buse JB. Patient-reported outcomes are superior in patients with Type 2 diabetes treated with liraglutide as compared with exenatide, when added to metformin, sulphonylurea or both: results from a randomized, open-label study. Diabet Med. 2011 Jun;28(6):715-23. doi: 10.1111/j.1464-5491.2011.03276.x.
PubMed 21388442Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbaek N, Holst J, Nauck M. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. doi: 10.1210/jc.2010-2822. Epub 2011 Mar 30.
PubMed 21450987Valentine WJ, Palmer AJ, Lammert M, Langer J, Brandle M. Evaluating the long-term cost-effectiveness of liraglutide versus exenatide BID in patients with type 2 diabetes who fail to improve with oral antidiabetic agents. Clin Ther. 2011 Nov;33(11):1698-712. doi: 10.1016/j.clinthera.2011.09.022. Epub 2011 Oct 21.
PubMed 22018679Bode BW, Brett J, Falahati A, Pratley RE. Comparison of the efficacy and tolerability profile of liraglutide, a once-daily human GLP-1 analog, in patients with type 2 diabetes >/=65 and <65 years of age: a pooled analysis from phase III studies. Am J Geriatr Pharmacother. 2011 Dec;9(6):423-33. doi: 10.1016/j.amjopharm.2011.09.007. Epub 2011 Nov 4.
PubMed 22055210Henry RR, Buse JB, Sesti G, Davies MJ, Jensen KH, Brett J, Pratley RE. Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program. Endocr Pract. 2011 Nov-Dec;17(6):906-13. doi: 10.4158/ep.17.6.906.
PubMed 22193143Zinman B, Schmidt WE, Moses A, Lund N, Gough S. Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme. Diabetes Obes Metab. 2012 Jan;14(1):77-82. doi: 10.1111/j.1463-1326.2011.01493.x. Epub 2011 Oct 30.
PubMed 21883806Niswender K, Pi-Sunyer X, Buse J, Jensen KH, Toft AD, Russell-Jones D, Zinman B. Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme. Diabetes Obes Metab. 2013 Jan;15(1):42-54. doi: 10.1111/j.1463-1326.2012.01673.x. Epub 2012 Sep 9.
PubMed 22862847Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23.
PubMed 23010561King AB, Montanya E, Pratley RE, Blonde L, Svendsen CB, Donsmark M, Sesti G. Liraglutide achieves A1C targets more often than sitagliptin or exenatide when added to metformin in patients with type 2 diabetes and a baseline A1C <8.0%. Endocr Pract. 2013 Jan-Feb;19(1):64-72. doi: 10.4158/EP12232.OR.
PubMed 23186975Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12.
PubMed 25504028Davidson JA, Orsted DD, Campos C. Efficacy and safety of liraglutide, a once-daily human glucagon-like peptide-1 analogue, in Latino/Hispanic patients with type 2 diabetes: post hoc analysis of data from four phase III trials. Diabetes Obes Metab. 2016 Jul;18(7):725-8. doi: 10.1111/dom.12653. Epub 2016 Apr 28.
PubMed 26936426
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Liraglutide or Exenatide Added to a Background Treatment of Metformin, Sulphonylurea or a Combination of Both on Glycaemic Control in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00518882
- Acronym / sponsor ID
- LEAD-6 / NN2211-1797
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 467 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 21 Aug 2007 (estimated)
- Results
- Posted 23 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea or a combination of both in subjects with type 2 diabetes. Two trial periods: A 26 week randomised, followed by a 52 week extension (14 + 38 weeks) where all subjects received liraglutide + OAD after previous randomisation to either liraglutide or exenatide, both combined with OAD treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | Experimental | Drug: liraglutideLiraglutide 1.8 mg once daily + subject's own OAD treatment |
| Exenatide | Active comparator | Drug: exenatideExenatide 10 mcg twice daily + subject's own OAD treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes
- Stable treatment with Oral Anti-Diabetic Drugs (metformin, sulphonylurea or a combination of both) for at least 3 months at the discretion of the Investigator
- HbA1C equal to or greater than 7.0% and equal to or lower than 11.0%
- Body Mass Index (BMI) equal to or lower than 45.0 kg/m2
Key exclusion criteria (7 listed)
- Previous treatment with insulin
- Treatment with any anti-diabetic drug other than metformin and sulphonylurea
- Any previous exposure to exenatide or liraglutide
- Impaired liver or/and renal function
- History of any significant cardiac events
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liraglutide1.8 mg once daily for s.c. (under the skin) injection. | Drug | Liraglutide |
| exenatide10 mcg twice daily for s.c. (under the skin) injection. | Drug | Exenatide |
Primary outcome
Change in Glycosylated A1c (HbA1c) at Week 26
Time frame: week 0, week 26
Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation)
54 secondary outcomes
Change in Glycosylated A1c (HbA1c), Weeks 26-78
Time frame: week 26, week 78
Change in Glycosylated A1c (HbA1c) at Week 78
Time frame: week 0, week 78
Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26
Time frame: week 0, week 26
Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78
Time frame: week 0, week 78
Change in Body Weight at Week 26
Time frame: week 0, week 26
Change in Body Weight, Weeks 26-78
Time frame: week 26, week 78
Change in Body Weight at Week 78
Time frame: week 0, week 78
Change in Fasting Plasma Glucose at Week 26
Time frame: week 0, week 26
Change in Fasting Plasma Glucose, Weeks 26-78
Time frame: week 26, week 78
Change in Fasting Plasma Glucose at Week 78
Time frame: week 0, week 78
Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26
Time frame: week 0, week 26
Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26
Time frame: week 0, week 26
Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 26
Time frame: week 0, week 26
Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78
Time frame: week 26, week 78
Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78
Time frame: week 26, week 78
Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78
Time frame: week 26, week 78
Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78
Time frame: week 0, week 78
Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78
Time frame: week 0, week 78
Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78
Time frame: week 0, week 78
Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 26
Time frame: week 0, week 26
Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 26
Time frame: week 0. week 26
Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 26
Time frame: week 0, week 26
Change in Mean Postprandial Increment of Plasma Glucose After Breakfast, Weeks 26-78
Time frame: week 26, week 78
Change in Mean Postprandial Increment of Plasma Glucose After Lunch, Weeks 26-78
Time frame: week 26, week 78
Change in Mean Postprandial Increment of Plasma Glucose After Dinner, Weeks 26-78
Time frame: week 26, week 78
Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 78
Time frame: week 0, week 78
Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 78
Time frame: week 0, week 78
Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78
Time frame: week 0, week 78
Change in Beta-cell Function at Week 26
Time frame: week 0, week 26
Change in Beta-cell Function, Weeks 26-78
Time frame: week 26, week 78
Change in Beta-cell Function at Week 78
Time frame: week 0, week 78
Change in Total Cholesterol at Week 26
Time frame: week 0, week 26
Change in Total Cholesterol, Weeks 26-78
Time frame: week 26, week 78
Change in Total Cholesterol at Week 78
Time frame: week 0, week 78
Change in Low-density Lipoprotein-cholesterol at Week 26
Time frame: week 0, week 26
Change in Low-density Lipoprotein-cholesterol, Weeks 26-78
Time frame: week 26, week 78
Change in Low-density Lipoprotein-cholesterol at Week 78
Time frame: week 0, week 78
Change in Very Low-density Lipoprotein-cholesterol at Week 26
Time frame: week 0, week 26
Change in Very Low-density Lipoprotein-cholesterol, Weeks 26-78
Time frame: week 26, week 78
Change in Very Low-density Lipoprotein-cholesterol at Week 78
Time frame: week 0, week 78
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19245711Sullivan SD, Alfonso-Cristancho R, Conner C, Hammer M, Blonde L. Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone. Cardiovasc Diabetol. 2009 Feb 26;8:12. doi: 10.1186/1475-2840-8-12.
- Results publication: PubMed 19491536McGill JB. Insights from the Liraglutide Clinical Development Program--the Liraglutide Effect and Action in Diabetes (LEAD) studies. Postgrad Med. 2009 May;121(3):16-25. doi: 10.3810/pgm.2009.05.1998.
- Results publication: PubMed 19515413Buse JB, Rosenstock J, Sesti G, Schmidt WE, Montanya E, Brett JH, Zychma M, Blonde L; LEAD-6 Study Group. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6). Lancet. 2009 Jul 4;374(9683):39-47. doi: 10.1016/S0140-6736(09)60659-0. Epub 2009 Jun 8.
- Results publication: PubMed 20332351Buse JB, Sesti G, Schmidt WE, Montanya E, Chang CT, Xu Y, Blonde L, Rosenstock J; Liraglutide Effect Action in Diabetes-6 Study Group. Switching to once-daily liraglutide from twice-daily exenatide further improves glycemic control in patients with type 2 diabetes using oral agents. Diabetes Care. 2010 Jun;33(6):1300-3. doi: 10.2337/dc09-2260. Epub 2010 Mar 23.
- Results publication: PubMed 21388442Schmidt WE, Christiansen JS, Hammer M, Zychma MJ, Buse JB. Patient-reported outcomes are superior in patients with Type 2 diabetes treated with liraglutide as compared with exenatide, when added to metformin, sulphonylurea or both: results from a randomized, open-label study. Diabet Med. 2011 Jun;28(6):715-23. doi: 10.1111/j.1464-5491.2011.03276.x.
- Results publication: PubMed 21450987Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbaek N, Holst J, Nauck M. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. doi: 10.1210/jc.2010-2822. Epub 2011 Mar 30.
- Results publication: PubMed 22018679Valentine WJ, Palmer AJ, Lammert M, Langer J, Brandle M. Evaluating the long-term cost-effectiveness of liraglutide versus exenatide BID in patients with type 2 diabetes who fail to improve with oral antidiabetic agents. Clin Ther. 2011 Nov;33(11):1698-712. doi: 10.1016/j.clinthera.2011.09.022. Epub 2011 Oct 21.
- Results publication: PubMed 22055210Bode BW, Brett J, Falahati A, Pratley RE. Comparison of the efficacy and tolerability profile of liraglutide, a once-daily human GLP-1 analog, in patients with type 2 diabetes >/=65 and <65 years of age: a pooled analysis from phase III studies. Am J Geriatr Pharmacother. 2011 Dec;9(6):423-33. doi: 10.1016/j.amjopharm.2011.09.007. Epub 2011 Nov 4.
- Results publication: PubMed 22193143Henry RR, Buse JB, Sesti G, Davies MJ, Jensen KH, Brett J, Pratley RE. Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program. Endocr Pract. 2011 Nov-Dec;17(6):906-13. doi: 10.4158/ep.17.6.906.
- Results publication: PubMed 21883806Zinman B, Schmidt WE, Moses A, Lund N, Gough S. Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme. Diabetes Obes Metab. 2012 Jan;14(1):77-82. doi: 10.1111/j.1463-1326.2011.01493.x. Epub 2011 Oct 30.
- Results publication: PubMed 22862847Niswender K, Pi-Sunyer X, Buse J, Jensen KH, Toft AD, Russell-Jones D, Zinman B. Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme. Diabetes Obes Metab. 2013 Jan;15(1):42-54. doi: 10.1111/j.1463-1326.2012.01673.x. Epub 2012 Sep 9.
- Results publication: PubMed 23010561Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
125 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing liraglutide and exenatide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 125 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 125 sites in United States, Germany, Poland, Denmark, France and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycosylated A1c (HbA1c) at Week 26 (time frame: week 0, week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00518882, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2017; AzTrials last refreshed its copy on 8 Nov 2026.