Non-Insulin-Dependent Diabetes MellitusPhase 3NCT00359112
AVANDAMET Versus Metformin And Sulphonylurea In People With Poorly Controlled Type 2 Diabetes
A Phase 3 study testing metformin, sulphonylurea and Avandamet in people with Non-Insulin-Dependent Diabetes Mellitus, run by GlaxoSmithKline at 142 sites in 11 countries.
Trial summary
This study compares the effects of Avandamet (rosiglitazone maleate/metformin) treatment and metformin plus sulphonylurea treatment in overweight people with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Insulin-Dependent Diabetes Mellitus
- What is being tested?
- metformin, sulphonylurea and Avandamet
- How many people
- 544 participants
- Where
- 142 sitesin 11 countries
- Study dates
- Feb 2004to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index > or = to 25 kg/m2.
- HbA1c > or =7% and < or =10% at screening.
- FPG > or = 7.0mmol/L (126mg/dL) at visit 2.
- Receiving at least 0.85g of metformin at constant dose(s) for at least 8 weeks prior to visit 1a.
- Female subjects must be postmenopausal or using effective contraceptive measures.
Who cannot join
- Use of any other oral antidiabetic drug other than metformin within 12 weeks prior to screening.
- Subjects with clinically significant ongoing oedema requiring pharmacological treatment or with a history of oedema requiring pharmacological treatment.
- Subjects with a history of severe hypoglycaemia.
- Renal disease or renal dysfunction.
- Presence of clinically significant hepatic disease.
- Presence of unstable or severe angina or known NYHA grade I-IV congestive heart failure.
- Subjects who have had a previous myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass graft or cerebrovascular accident within 3 months prior to screening.
Trial locations and contacts
142 sites in 11 countries.
142 sites in 11 countries
Germany35 sites
GSK Investigational Site
Beckum, North Rhine-Westphalia, 59269
GSK Investigational Site
Bergkamen-Rünthe, North Rhine-Westphalia, 59192
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44869
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51069
GSK Investigational Site
Dinslaken, North Rhine-Westphalia, 46537
GSK Investigational Site
Dortmund, North Rhine-Westphalia, 44137
GSK Investigational Site
Dresden, Saxony, 01219
GSK Investigational Site
Einbeck, Lower Saxony, 37574
GSK Investigational Site
Elmshorn, Schleswig-Holstein, 25335
GSK Investigational Site
Essen, North Rhine-Westphalia, 45134
GSK Investigational Site
Essen, North Rhine-Westphalia, 45359
GSK Investigational Site
Goch, North Rhine-Westphalia, 47574
GSK Investigational Site
Grafing, Bavaria, 85567
GSK Investigational Site
Großalmerode, Hesse, 37247
GSK Investigational Site
Güglingen, Baden-Wurttemberg, 74363
GSK Investigational Site
Hanover, Lower Saxony, 30519
GSK Investigational Site
Herzogenaurach, Bavaria, 91074
GSK Investigational Site
Immenstadt im Allgäu, Bavaria, 87509
GSK Investigational Site
Isernhagen-Süd, Lower Saxony, 30916
GSK Investigational Site
Kippenheim, Baden-Wurttemberg, 77971
GSK Investigational Site
Königsfeld im Schwarzwald, Baden-Wurttemberg, 78126
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55116
GSK Investigational Site
Neuwied, Rhineland-Palatinate, 56564
GSK Investigational Site
Oberteisendorf, Bavaria, 83317
GSK Investigational Site
Papenburg, Lower Saxony, 26871
GSK Investigational Site
Rhaunen, Rhineland-Palatinate, 55624
GSK Investigational Site
Saaldorf, Bavaria, 83416
GSK Investigational Site
Saarlouis, Saarland, 66740
GSK Investigational Site
Speyer, Rhineland-Palatinate, 67346
GSK Investigational Site
Viersen, North Rhine-Westphalia, 41749
GSK Investigational Site
Waldshut-Tiengen, Baden-Wurttemberg, 79961
GSK Investigational Site
Wallerfing, Bavaria, 94574
GSK Investigational Site
Weinheim, Baden-Wurttemberg, 69469
GSK Investigational Site
Wolmirstedt, Saxony-Anhalt, 39326
GSK Investigational Site
Würzburg, Bavaria, 97072
Spain27 sites
GSK Investigational Site
Alcobendas/Madrid, 28100
GSK Investigational Site
Alcora/Castellón, 12110
GSK Investigational Site
Alicante
GSK Investigational Site
Alzira, 46600
GSK Investigational Site
Artana/Castellón, 12527
GSK Investigational Site
Barcelona, 08015
GSK Investigational Site
Barcelona, 08022
GSK Investigational Site
Benicassim (Castellon)
GSK Investigational Site
Cáceres, 10004
GSK Investigational Site
Cadiz, 11009
GSK Investigational Site
Castellon
GSK Investigational Site
Girona
GSK Investigational Site
Granada, 18014
GSK Investigational Site
Madrid, 28034
GSK Investigational Site
Madrid, 28037
GSK Investigational Site
Madrid, 28041
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Málaga, 29009
GSK Investigational Site
Mérida, 6800
GSK Investigational Site
Móstoles/Madrid, 28935
GSK Investigational Site
Onda (Castellon)
GSK Investigational Site
Pontevedra, 36002
GSK Investigational Site
Sabadell (Barcelona), 08208
GSK Investigational Site
Sant Joan d'Alacant, 3550
GSK Investigational Site
Santa Coloma de Gramanet (Barcelona), 08923
GSK Investigational Site
Tarrasa, Barcelona, 08221
GSK Investigational Site
Valencia, 46010
France15 sites
GSK Investigational Site
Anzin, 59410
GSK Investigational Site
Briollay, 49125
GSK Investigational Site
Commelle, 42120
GSK Investigational Site
Cremeaux, 42260
GSK Investigational Site
Évron, 53600
GSK Investigational Site
Laval, 53000
GSK Investigational Site
Louverné, 53950
GSK Investigational Site
Lyon, 69007
GSK Investigational Site
Paris, 75015
GSK Investigational Site
Roanne, 42300
GSK Investigational Site
Roubaix, Hauts-de-France, 59100
GSK Investigational Site
Saint-Ouen, 93400
GSK Investigational Site
Sainte-Suzanne, 53270
GSK Investigational Site
Segré, 49500
GSK Investigational Site
Vénissieux, 69200
Switzerland14 sites
GSK Investigational Site
Bern, 3007
GSK Investigational Site
Emmenbrücke, 6020
GSK Investigational Site
Gettnau, 6142
GSK Investigational Site
Jegenstorf, 3303
GSK Investigational Site
Lucerne, 6004
GSK Investigational Site
Lugano, 6900
GSK Investigational Site
Pregassona, 6963
GSK Investigational Site
Salmsach, 8599
GSK Investigational Site
St-Maurice, 1890
GSK Investigational Site
Steckborn, 8266
GSK Investigational Site
Winterthur, 8400
GSK Investigational Site
Winterthur, 8405
GSK Investigational Site
Zurich, 8046
GSK Investigational Site
Zurich, 8050
Belgium12 sites
GSK Investigational Site
Bruges, 8000
GSK Investigational Site
Brussels, 1030
GSK Investigational Site
Brussels, 1210
GSK Investigational Site
Champion, 5020
GSK Investigational Site
Heverlee, 3001
GSK Investigational Site
Landen, 3400
GSK Investigational Site
Oostham, 3945
GSK Investigational Site
Petit-Rechain, 4800
GSK Investigational Site
Pulle, 2243
GSK Investigational Site
Tessenderlo, 3980
GSK Investigational Site
Tremelo, 3120
GSK Investigational Site
Willebroek, 2830
Netherlands12 sites
GSK Investigational Site
Beek en Donk, 5741 CG
GSK Investigational Site
Beerzerveld, 7685 PG
GSK Investigational Site
Heerlen, 6416 EG
GSK Investigational Site
Hoogvliet, 3192 JN
GSK Investigational Site
Landgraaf, 6373 JS
GSK Investigational Site
Musselkanaal, 9581 AJ
GSK Investigational Site
Oude Pekela, 9665 AR
GSK Investigational Site
Spijkenisse, 3207 NB
GSK Investigational Site
The Hague, 2582 LJ
GSK Investigational Site
Woerden, 3443 GG
GSK Investigational Site
Zaandam, 1504 JA
GSK Investigational Site
Zieuwent, 7136 KH
Italy8 sites
GSK Investigational Site
Arenzano (GE), Liguria, 16011
GSK Investigational Site
Bologna, Emilia-Romagna, 40138
GSK Investigational Site
Città Di Castello (PG), Umbria, 06012
GSK Investigational Site
Ferrara, Emilia-Romagna, 44100
GSK Investigational Site
Genoa, Liguria, 16132
GSK Investigational Site
Ravenna, Emilia-Romagna, 48100
GSK Investigational Site
Sassari, Sardinia, 07100
GSK Investigational Site
Terni, Umbria, 05100
United Kingdom7 sites
GSK Investigational Site
Bath, Somerset, BA1 3NG
GSK Investigational Site
Blackpool, Lancashire, FY4 3AD
GSK Investigational Site
Bristol, BS2 8HW
GSK Investigational Site
Glasgow, Lanarkshire, G3 8YJ
GSK Investigational Site
Glasgow, Lanarkshire, G69 7AD
GSK Investigational Site
Leeds, LS12 1JE
GSK Investigational Site
Sheffield, S5 7AU
Mexico5 sites
GSK Investigational Site
Durango, Durango, 3400
GSK Investigational Site
Guadalajara, Jalisco, 44340
GSK Investigational Site
Mexico City, 11850
GSK Investigational Site
Pachuca, Hidalgo, 42039
GSK Investigational Site
Tijuana, Baja California Norte, 22320
Lithuania4 sites
GSK Investigational Site
Kaunas, LT-44320
GSK Investigational Site
Kaunas, LT-49335
GSK Investigational Site
Vilnius, LT-07156
GSK Investigational Site
Vilnius, LT-08661
Ireland3 sites
GSK Investigational Site
Blanchardstown, 15
GSK Investigational Site
Dublin, 8
GSK Investigational Site
Dublin, 9
About this study
Official title: A Randomised, Multi-Centre, Phase IV, Double-Blind, Parallel Group Study Comparing the Effects of 52 Weeks Administration of AVANDAMET and Metformin Plus Sulphonylurea on Change in HbA1c From Baseline in Overweight Type 2 Diabetics Poorly Controlled on Metformin.
This study compares the effects of Avandamet (rosiglitazone maleate/metformin) treatment and metformin plus sulphonylurea treatment in overweight people with type 2 diabetes.
- Conditions
- Non-Insulin-Dependent Diabetes Mellitus
- Being tested
- metformin, sulphonylurea, Avandamet
- Keywords
- Type 2 diabetes, overweight, AVANDAMET, metformin, sulphonylurea
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metforminDrug
sulphonylureaDrug
AvandametDrug
Also called metformin, sulphonylurea
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c level from baseline following 52 weeks of treatment.
Secondary outcomes (8)
Change in FPG (fasting plasma glucose)
insulin sensitivity
beta cell function
change in PAI-1
CRP
number of hypoglycaemic events
Change in 24 hr ABPM
Diabetes treatment satisfaction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2006 (estimated)
- Study startFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Insulin-Dependent Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Double blind
- Enrolment
- 544 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, DM, FRCP, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00359112
- Sponsor's protocol ID
- AVM100264
- Status last verified
- May 2009
- First submitted
- 28 Jul 2006
- Last updated
- 18 May 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Multi-Centre, Phase IV, Double-Blind, Parallel Group Study Comparing the Effects of 52 Weeks Administration of AVANDAMET and Metformin Plus Sulphonylurea on Change in HbA1c From Baseline in Overweight Type 2 Diabetics Poorly Controlled on Metformin.
- ClinicalTrials.gov ID
- NCT00359112
- Acronym / sponsor ID
- AVM100264
- Conditions
- Non-Insulin-Dependent Diabetes Mellitus
- Keywords
- Type 2 diabetes, overweight, AVANDAMET, metformin, sulphonylurea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 544 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- First posted
- 1 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares the effects of Avandamet (rosiglitazone maleate/metformin) treatment and metformin plus sulphonylurea treatment in overweight people with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Body mass index > or = to 25 kg/m2.
- HbA1c > or =7% and < or =10% at screening.
- FPG > or = 7.0mmol/L (126mg/dL) at visit 2.
- Receiving at least 0.85g of metformin at constant dose(s) for at least 8 weeks prior to visit 1a.
- Female subjects must be postmenopausal or using effective contraceptive measures.
Key exclusion criteria (7 listed)
- Use of any other oral antidiabetic drug other than metformin within 12 weeks prior to screening.
- Subjects with clinically significant ongoing oedema requiring pharmacological treatment or with a history of oedema requiring pharmacological treatment.
- Subjects with a history of severe hypoglycaemia.
- Renal disease or renal dysfunction.
- Presence of clinically significant hepatic disease.
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 |
|---|---|---|
| metformin | Drug | – |
| sulphonylurea | Drug | – |
| AvandametAlso: metformin, sulphonylurea | Drug | – |
Primary outcome
Change in HbA1c level from baseline following 52 weeks of treatment.
8 secondary outcomes
Change in FPG (fasting plasma glucose)
insulin sensitivity
beta cell function
change in PAI-1
CRP
number of hypoglycaemic events
Change in 24 hr ABPM
Diabetes treatment satisfaction.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2009.
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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.
GSK Clinical Trials, DM, FRCP study director
GlaxoSmithKline
142 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing metformin, sulphonylurea and Avandamet in people with Non-Insulin-Dependent Diabetes Mellitus, run by GlaxoSmithKline at 142 sites in 11 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 5 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 18 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 142 sites in Germany, Spain, France, Switzerland, Belgium and 6 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 HbA1c level from baseline following 52 weeks of treatment.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2009.