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Diabetes Mellitus, Type 2Phase 4EAGLENCT01117350

Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure

A Phase 4 study testing Insulin glargine, Liraglutide and Metformin in people with Diabetes Mellitus, Type 2, run by Sanofi at 136 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Primary objective: To demonstrate the superiority of insulin glargine over liraglutide in terms of percentage of patients reaching a Glycosylated Haemoglobin (HbA1c) < 7% at the end of the comparative period (24 weeks) in Type 2 diabetic patients failing lifestyle management and oral agents Secondary objectives of the… Read more about this study

Who is it for?
Ages 35 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Insulin glargine, Liraglutide and Metformin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
978 participants
Where
136 sitesin 17 countries
Study dates
Jul 2010to Mar 2013
Phase
Phase 4
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 35 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients With Type 2 Diabetes diagnosed for at least 1 year,
  • Treated with lifestyle interventions and metformin at the maximum tolerated dosage (with a minimum daily dosage of 1g), either alone or in combination with an oral insulin secretagogue (sulfonylurea, glinide or DiPeptidyl Peptidase IV inhibitor), for more than 3 months,
  • 7.5% < HbA1c <= 12%,
  • Body Mass Index (BMI) between 25 and 40 kg/m2 inclusively,
  • Ability and willingness to perform PG (Plasma Glucose) self monitoring using the sponsor-provided glucose meter and to complete the patient diary,
  • Willingness and ability to comply with the study protocol,
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  • Signed informed consent obtained prior to any study procedure.
  • Patients treated with liraglutide (at the maximal tolerated dosage), having a mean FPG ≥ 250 mg/dL at visit 10 (Week 12) or visit 11 (Week 18), or a HbA1c≥ 7% at visit 12 (Week 24)
  • Dosage of metformin compliant with the inclusion criteria of visit 1 (i.e. maximum tolerated dosage, with a minimum daily dosage of 1g), and maintained stable during the comparative period.

Who cannot join

  • Previous treatment with Glucagon Like Peptide-1 analogues or insulin in the past year (except in case of temporary treatment for gestational diabetes, surgery, hospitalization...),
  • Treatment with thiazolidinediones or α-Glucosidases inhibitors within 3 months prior to study entry,
  • Diabetes other than Type 2 diabetes (e.g. secondary to pancreatic disorders, drug or chemical agents intake),
  • Pregnant women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method),
  • Lactating women,
  • Hospitalized patients (except hospitalization for routine diabetes check-up),
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  • Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to study entry, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study, documented by a retina examination within 2 years prior to study entry,
  • Impaired renal function (creatinine clearance < 60 mL/mn),
  • Impaired hepatic function (Alanine Aminotransferase, Aspartate Aminotransferase 2.5 times the upper limit of normal range),
  • Personal or family history of medullary thyroid carcinoma,
  • Multiple endocrine neoplasia syndrome type 2,
  • Severe gastro-intestinal disease (including inflammatory bowel disease or diabetic gastroparesis),
  • Congestive heart failure,
  • History of acute pancreatitis,
  • Treatment with corticosteroids with potential systemic action for more than 10 days within 3 months prior to study entry,
  • Alcohol or drug abuse in the past 5 years,
  • History of sensitivity to the study drugs or to drugs with a similar chemical structure.
  • Night shift worker,
  • Presence of any condition (medical, psychological, social or geographical), current or anticipated that would compromise the patients safety or limit the patient successful participation in the study,
  • Participation in a clinical trial (drug or device) within 3 months prior to study entry,
  • Refusal or inability to give informed consent to participate in the study,
  • Patient is the Investigator or any sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
  • Additional exclusion criteria for the extension period:
  • Treatment with oral antidiabetic drugs other than metformin and patient's usual sulfonylurea if any, or with insulin during the comparative period (except in case of an emergency, for a period of time less than 7 days),
  • Treatment with corticosteroids with potential systemic action within the last 3 months of the comparative period.
  • History of sensitivity to insulin glargine.

Trial locations and contacts

136 sites in 17 countries.

136 sites in 17 countries

United States45 sites

  • Investigational Site Number 840009

    Arlington Heights, Illinois, 60004

  • Investigational Site Number 840015

    Atco, New Jersey, 08004

  • Investigational Site Number 840023

    Birmingham, Alabama, 35294

  • Investigational Site Number 840008

    Blackwood, New Jersey, 08012

  • Investigational Site Number 840006

    Bryan, Ohio, 43506

  • Investigational Site Number 840016

    Carnegie, Pennsylvania, 15106

  • Investigational Site Number 840035

    Cincinnati, Ohio, 45220

  • Investigational Site Number 840001

    Dallas, Texas, 75230

  • Investigational Site Number 840007

    Dallas, Texas, 75246

  • Investigational Site Number 840028

    Denver, Colorado, 80220

  • Investigational Site Number 840038

    Eagan, Minnesota, 55122

  • Investigational Site Number 840049

    Fargo, North Dakota, 58103

  • Investigational Site Number 840002

    Goodyear, Arizona, 85395

  • Investigational Site Number 840034

    Grand Junction, Colorado, 81501

  • Investigational Site Number 840005

    Hickory, North Carolina, 28601

  • Investigational Site Number 840013

    Houston, Texas, 77030

  • Investigational Site Number 840050

    Indianapolis, Indiana, 46222

  • Investigational Site Number 840031

    Kansas City, Kansas, 66160

  • Investigational Site Number 840017

    La Jolla, California, 92037

  • Investigational Site Number 840036

    La Mesa, California, 91942

  • Investigational Site Number 840022

    Lawrenceville, Georgia

  • Investigational Site Number 840037

    Loma Linda, California, 92357

  • Investigational Site Number 840045

    Long Beach, California, 90822

  • Investigational Site Number 840026

    Longmont, Colorado, 80501

  • Investigational Site Number 840027

    Mineola, New York, 11501

  • Investigational Site Number 840030

    Minneapolis, Minnesota, 55414

  • Investigational Site Number 840048

    Mission Hills, California, 91345

  • Investigational Site Number 840033

    Mission Viejo, California, 92691

  • Investigational Site Number 840004

    Paducah, Kentucky, 42003

  • Investigational Site Number 840019

    Palm Springs, California, 92262

  • Investigational Site Number 840047

    Phoenix, Arizona, 85020

  • Investigational Site Number 840024

    Rapid City, South Dakota, 57701

  • Investigational Site Number 840014

    Renton, Washington, 98057

  • Investigational Site Number 840010

    Rockville, Maryland, 20850

  • Investigational Site Number 840029

    Roswell, Georgia, 30076

  • Investigational Site Number 840039

    San Diego, California, 92101

  • Investigational Site Number 840042

    San Diego, California, 92161

  • Investigational Site Number 840046

    Spokane, Washington, 99220-3649

  • Investigational Site Number 840051

    Springfield, Illinois, 62704

  • Investigational Site Number 840012

    St Louis, Missouri, 63128

  • Investigational Site Number 840044

    St Louis, Missouri, 63141

  • Investigational Site Number 840011

    Staten Island, New York, 10301-3914

  • Investigational Site Number 840043

    Tustin, California, 92780

  • Investigational Site Number 840020

    Uniontown, Pennsylvania, 15401

  • Investigational Site Number 840052

    Winston-Salem, North Carolina, 27103

Other trials in United States

France14 sites

  • Investigational Site Number 250-007

    Annecy, 74000

  • Investigational Site Number 250-017

    Bois-Guillaume, 76233

  • Investigational Site Number 250-003

    Boulogne-Billancourt, 92100

  • Investigational Site Number 250-011

    Brest, 29000

  • Investigational Site Number 250-008

    Cahors, 46005

  • Investigational Site Number 250-012

    Corbeil-Essonnes, 91100

  • Investigational Site Number 250-009

    La Rochelle, 17019

  • Investigational Site Number 250-004

    Le Creusot, 71200

  • Investigational Site Number 250-006

    Mantes-la-Jolie, 78200

  • Investigational Site Number 250-021

    Nanterre, 92014

  • Investigational Site Number 250022

    Strasbourg, 67000

  • Investigational Site Number 250-020

    Strasbourg, 67091

  • Investigational Site Number 250-002

    Toulouse, 31300

  • Investigational Site Number 250-016

    Vénissieux, 69200

Other trials in France

Spain10 sites

  • Investigational Site Number 724007

    Bilbao, 48013

  • Investigational Site Number 724006

    Cadiz, 11009

  • Investigational Site Number 724001

    Las Palmas de Gran Canaria, 35020

  • Investigational Site Number 724005

    Lleida

  • Investigational Site Number 724008

    Madrid, 28040

  • Investigational Site Number 724003

    Málaga, 29010

  • Investigational Site Number 724009

    Sabadell, 08208

  • Investigational Site Number 721002

    Valencia, 46014

  • Investigational Site Number 724004

    Valencia, 46015

  • Investigational Site Number 724010

    Vigo, 36211

Other trials in Spain

Russia8 sites

  • Investigational Site Number 643-009

    Kazan'

  • Investigational Site Number 643008

    Kirov, 610014K

  • Investigational Site Number 643001

    Moscow, 117036

  • Investigational Site Number 643004

    Saint Petersburg, 195257

  • Investigational Site Number 643006

    Samara

  • Investigational Site Number 643007

    Samara

  • Investigational Site Number 643005

    Saratov

  • Investigational Site Number 643003

    St-Ptetersburg, 194354

Other trials in Russia

Austria7 sites

  • Investigational Site Number 040-006

    Salzburg, 5010

  • Investigational Site Number 040-007

    Salzburg, 5020

  • Investigational Site Number 040-003

    Stockerau, A-2000

  • Investigational Site Number 040-005

    Vienna, A-1010

  • Investigational Site Number 040-002

    Vienna, A-1090

  • Investigational Site Number 040-001

    Vienna, A-1130

  • Investigational Site Number 040-004

    Vienna, A-1220

Other trials in Austria

Netherlands7 sites

  • Investigational Site Number 528004

    's-Hertogenbosch

  • Investigational Site Number 528001

    Beek, 6191JW

  • Investigational Site Number 528006

    Enschede, 7523JJ

  • Investigational Site Number 528002

    Hoogeveen, 7909AA

  • Investigational Site Number 528007

    Nijverdal, 7442LS

  • Investigational Site Number 528003

    Rotterdam

  • Investigational Site Number 528005

    Woerden

Other trials in Netherlands

Brazil6 sites

  • Investigational Site Number 076-004

    Belém, 66073-000

  • Investigational Site Number 076-007

    Fortaleza, 60015-052

  • Investigational Site Number 076-001

    Fortaleza, 60115-282

  • Investigational Site Number 076-006

    Fortaleza, 60430-370

  • Investigational Site Number 076-005

    Marília, 17519-101

  • Investigational Site Number 076-002

    São Paulo, 01244-030

Other trials in Brazil

Canada6 sites

  • Investigational Site Number 124-003

    Mississauga, L5M2V8

  • Investigational Site Number 124-001

    Montreal, H2W1T8

  • Investigational Site Number 124-006

    Montreal, H3A1A1

  • Investigational Site Number 124-004

    Toronto, M5C 2T2

  • Investigational Site Number 124-008

    Vancouver, V5Z1M9

  • Investigational Site Number 124-007

    Victoria, V8R1J8

Other trials in Canada

Sweden6 sites

  • Investigational Site Number 752-03

    Ängelholm, 26281

  • Investigational Site Number 752-002

    Gothenburg, 41665

  • Investigational Site Number 752-005

    Karlskoga, 69181

  • Investigational Site Number 752-006

    Motala, 59185

  • Investigational Site Number 752-007

    Örebro, 70235

  • Investigational Site Number 752-001

    Stockholm, 17176

Other trials in Sweden

Czechia5 sites

  • Investigational Site Number 203001

    Hradec Králové, 50005

  • Investigational Site Number 203003

    Krnov, 79401

  • Investigational Site Number 203005

    Kroměříž, 76701

  • Investigational Site Number 203002

    Olomouc, 77900

  • Investigational Site Number 203006

    Prague, 15000

Other trials in Czechia

Slovakia5 sites

  • Investigational Site Number 703002

    Bratislava, 81102

  • Investigational Site Number 703004

    Košice, 04013

  • Investigational Site Number 703001

    Nitra, 94911

  • Investigational Site Number 703005

    Nové Mesto nad Váhom, 091501

  • Investigational Site Number 703003

    Žilina, 01001

Other trials in Slovakia

Finland4 sites

  • Investigational Site Number 246003

    Harjavalta, 29200

  • Investigational Site Number 246001

    Kuopio, 70210

  • Investigational Site Number 246002

    Oulu, 90100

  • Investigational Site Number 246004

    Turku, 20100

Other trials in Finland

Mexico4 sites

  • Investigational Site Number 484004

    Guadalajara, 44630

  • Investigational Site Number 484001

    México, 07760

  • Investigational Site Number 484002

    México, 14000

  • Investigational Site Number 484003

    Zapopan, 45200

Other trials in Mexico

Greece3 sites

  • Investigational Site Number 300003

    Athens

  • Investigational Site Number 300004

    Athens

  • Investigational Site Number 300001

    Haidari, Athens, 12462

Other trials in Greece

Israel3 sites

  • Investigational Site Number 376004

    Hadera

  • Investigational Site Number 376002

    Petah Tikva, 49361

  • Investigational Site Number 376003

    Tel Aviv

Other trials in Israel

Turkey (Türkiye)2 sites

  • Investigational Site Number 792-001

    Antalya, 07070

  • Investigational Site Number 792-002

    Istanbul, 34890

Other trials in Turkey (Türkiye)

Ireland1 site

  • Investigational Site Number 372001

    Dublin

Other trials in Ireland

About this study

Official title: A 24-week, Multicenter, International, Randomized (1:1), Parallel-group, Open-label, Comparative Study of Insulin Glargine Versus Liraglutide in Insulin-naïve Patients With Type 2 Diabetes Treated With Oral Agents and Not Adequately Controlled, Followed by a 24-week Extension Period With Insulin Glargine for Patients Not Adequately Controlled With Liraglutide

Primary objective:

To demonstrate the superiority of insulin glargine over liraglutide in terms of percentage of patients reaching a Glycosylated Haemoglobin (HbA1c) < 7% at the end of the comparative period (24 weeks) in Type 2 diabetic patients failing lifestyle management and oral agents

Read more

Secondary objectives of the comparative period (24 weeks):

>To assess the effect of insulin glargine in comparison with liraglutide on:

  • HbA1c level
  • Percentage of patients whose HbA1c has decreased but remains >= 7% at the end of the comparative period
  • Percentage of patients whose HbA1c has increased at the end of the comparative period
  • Fasting Plasma Glucose (FPG)
  • 7-point Plasma Glucose (PG) profiles
  • Hypoglycemia occurrence
  • Body weight
  • Adverse events

Objectives of the extension period (24 weeks):

>To assess the effect of insulin glargine in patients not adequately controlled with liraglutide on:

  • HbA1c level
  • FPG
  • 7-point PG profiles
  • Hypoglycemia occurrence
  • Body weight
  • Adverse events
Read the detailed description

Maximum estimated study duration per patient: either 27 weeks (patients randomized to insulin glargine arm) or 51 weeks (patients randomized to liraglutide arm) broken down as follow:

  • A 2-week of screening period,
  • A 24-week comparative period,
  • A 24-week extension period (only for patients treated with liraglutide, not adequately controlled at the end of the comparative period),
  • A 1-week follow-up period
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin glargineDrug

    Also called Lantus®

    100 Units/mL solution for injection in a pre-filled SoloStar pen

  • LiraglutideDrug

    Also called Victoza®

    6 mg/mL solution for injection in a 3-mL pre-filled pen (18mg)

  • MetforminDrug

    Metformin was a background treatment, mandatory for each patient randomized in the study (at the minimum dose of 1g/day). It was not supplied by the sponsor.

Study groups in NCT01117350
Study groupRoleWhat they receive
Insulin GlargineExperimentalInsulin glargine administered once a day, in the morning or in the evening, at the most convenient time. The time of injection, once chosen was to remain unchanged during the whole duration of the study. The starting dose was 0.2 Unit per kilogram of body weight or 10 Units. Patients were empowered to adjust their insulin doses, under strict investigator's supervision. Insulin titration (by 2 or 4 Units) was done every 3 days according to the median value of Fasting Plasma Glucose (FPG) of the last 3 days. The goal was to achieve 70 < FPG ≤ 100 mg/dL (3.9 < FPG ≤ 5.5 mmol/L). Minor deviations from the titration scheme could be allowed, based on Investigator's judgment and patient's situation.
Receives: Drug: Insulin glargine; Drug: Metformin
LiraglutideActive comparatorLiraglutide administered once a day, in the morning or in the evening, at the most convenient time. The time of injection , once chosen was to remain unchanged during the whole duration of the study. The dose was 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24. The dose might be decreased to 1.2 mg for safety reasons (e.g. gastro-intestinal tolerability), based on Investigator's judgment.
Receives: Drug: Liraglutide; Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Comparative Period

    The value at the end of the comparative period was defined as the last available HbA1c value measured during the comparative period plus 14 days after the last dose of Investigational Product (i.e. last-observation-carried-forward [LOCF] value).

    Measured: week 12, week 24

Secondary outcomes (16)

  1. Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Decreased But Remains ≥7% at the End of the Comparative Period

    Percentage of patients with:

    • HbA1c value at end of the comparative period (LOCF) lower than HbA1c baseline value

    AND

    • HbA1c value at end of the comparative period (LOCF) ≥7%

    Measured: baseline (week -2), week 12, week 24

  2. Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Increased at the End of the Comparative Period

    Percentage of patients with HbA1c value at end of the comparative period (LOCF) higher than HbA1c baseline value

    Measured: baseline (week -2), week 12, week 24

  3. Glycosylated Haemoglobin (HbA1c): Change From Baseline to the End of Comparative Period

    Change in HbA1C from baseline to the last observation carried forward (LOCF) measured during the comparative period = LOCF value - baseline value

    Measured: baseline (week -2), week 12, week 24

  4. Glycosylated Haemoglobin (HbA1c): Change From Beginning to the End of the Extension Period

    Change in HbA1C from beginning of the extension period (week 24) to the last observation carried forward (LOCF) measured during the extension period = LOCF value - week 24 value

    Measured: week 24, week 36, week 48

  5. Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Extension Period

    Value at the end of the extension period defined as last available HbA1c value measured during the extension period (i.e. last observation carried forward (LOCF) value)

    Measured: week 36, week 48

  6. Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Baseline to the End of the Comparative Period

    SMFPG = mean value of Self-Monitored Fasting Plasma Glucose measurements over 3 consecutive days in the week before each visit

    Value at the end of the comparative period defined as last available value during the comparative period (i.e. last-observation-carried-forward [LOCF] value)

    Change = LOCF value - baseline value

    Measured: baseline (week 0), week 6, week 12, week 18, week 24

  7. Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Beginning to the End of the Extension Period

    SMFPG = mean value of Self-Monitored Fasting Plasma Glucose measurements over 3 consecutive days in the week before each visit

    Value at the end of the extension period defined as last available value during the extension period (i.e. last-observation-carried-forward [LOCF] value)

    Change = LOCF value - week 24 value

    Measured: week 24, week 30, week 36, week 48

  8. Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Baseline to the End of the Comparative Period

    Self-monitored 7-point plasma glucose profiles (before and 2 hours after the start of breakfast, lunch and dinner, and at bedtime) recorded on 3 consecutive days in the week before each visit

    Value at the end of the comparative period defined as last available value during the comparative period (i.e. last-observation-carried-forward [LOCF] value)

    Change = LOCF value - baseline value

    Measured: baseline (week 0), week 12, week 24

  9. Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Beginning to the End of the Extension Period

    Self-monitored 7-point plasma glucose profiles (before and 2 hours after the start of breakfast, lunch and dinner, and at bedtime) recorded on 3 consecutive days in the week before each visit

    Value at the end of the extension period defined as last available value during the extension period (i.e. last-observation-carried-forward [LOCF] value)

    Change = LOCF value - week 24 value

    Measured: week 24, week 36, week 48

  10. Body Weight: Change From Baseline to the End of the Comparative Period

    Change = Last weight value measured during the comparative period (LOCF value) - weight value at baseline

    Measured: baseline (week 0), week 2, week 6, week 12, week 18, week 24

  11. Body Weight: Change From Beginning to End of the Extension Period

    Change = Last weight value measured during the extension period (LOCF value) - weight value at beginning of the Extension Period (Week 24)

    Measured: week 24, week 30, week 36, week 48

  12. Daily Dose of Insulin Glargine

    Measured: week 1, week 2, week 6, week 12, week 24

  13. Daily Dose of Liraglutide

    Measured: week 1, week 2, week 6, week 12, week 24

  14. Daily Dose of Insulin Glargine Administered During the Extension Period

    Measured: week 30, week 36, week 48

  15. Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Comparative Period

    Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia.

    Severe symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia, requiring the assistance of another person for active administration of carbohydrate, glucagon or other countermeasure because the patient could not treat him/herself due to acute neurological impairment directly resulting from the hypoglycemia (assistance by another person when the patient could have treated him/herself was not considered as requiring assistance)and one of the following criteria:

    • The event was associated with a measured PG level < 36 mg/dL (2 mmol/L),
    • Or, in absence of PG value, the event was associated with neurological recovery attributable to the restoration of PG to normal, after oral carbohydrate, intravenous glucose or glucagon administration.

    Measured: all across the comparative period (from week 0 to week 24)

  16. Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Extension Period

    Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia.

    Severe symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia, requiring the assistance of another person for active administration of carbohydrate, glucagon or other countermeasure because the patient could not treat him/herself due to acute neurological impairment directly resulting from the hypoglycemia (assistance by another person when the patient could have treated him/herself was not considered as requiring assistance)and one of the following criteria:

    • The event was associated with a measured PG level < 36 mg/dL (2 mmol/L),
    • Or, in absence of PG value, the event was associated with neurological recovery attributable to the restoration of PG to normal, after oral carbohydrate, intravenous glucose or glucagon administration.

    Measured: all across the extension period (from week 24 to week 48)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionOct 2012
  4. Study completionMar 2013

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
978 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01117350
Sponsor's protocol ID
LANTU_C_03680
Other IDs
2010-018437-21, U1111-1116-9684
Acronym
EAGLE
Status last verified
Mar 2014
First submitted
4 May 2010
Last updated
11 Apr 2014

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Insulin glargine, Liraglutide and Metformin in people with Diabetes Mellitus, Type 2, run by Sanofi at 136 sites in 17 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 9 inclusion and 26 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 11 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 136 sites in United States, France, Spain, Russia, Austria and 12 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 29 Jan 2014). 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?

Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Comparative Period (time frame: week 12, week 24). 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 NCT01117350.

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 11 Apr 2014.

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