GLP112757 Albiglutide in participants With Type 2 Diabetes Mellitus V2

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide Administered in Combination With Metformin and Glimepiride Compared With Metformin Plus Glimepiride and Placebo and With Metformin Plus Glimepiride and Pioglitazone in Subjects With Type 2 Diabetes Mellitus

• IRAS ID

  22511

• Sponsor organisation

  GlaxoSmithKline Research and Development Ltd.

• Eudract number

  2008-007664-42

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a phase III, randomised, double-blind, placebo- and active-controlled, parallel-group, multicenter study. The purpose of this study is to evaluate whether treatment with Albiglutide is safe and can help treat people with type 2 diabetes. This study will also find out if taking albiglutide in combination with metformin and glimepiride is better than taking metformin and glimepiride or taking metformin, glimepiride, and pioglitazone. It is planned that about 600 participants with type 2 diabetes, 18 years of age or older, will be in this study. Approximately 8 of these participants will be in the UK. This study will last about 172 weeks, or approximately three years.The participant will be assigned by chance to 1 of the 3 study groups:<ul> <li style="color: Group 1: Albiglutide matching placebo weekly metformin daily glimepiride 4 mg daily (may be lowered to 2 mg daily) pioglitazone 30 mg daily (may be increased up to 45 mg daily)</li> <li style="color: Group 2: Albiglutide 30 mg weekly (may be increased up to 50 mg weekly) metformin daily glimepiride 4 mg daily (may be lowered to 2 mg daily) pioglitazone matching placebo daily</li> <li style="color: Group 3: Albiglutide matching placebo weekly metformin daily glimepiride 4 mg daily (may be lowered to 2 mg daily) pioglitazone matching placebo daily</li></ul>The study will comprise 4 study periods: Screening, Run-in/Stabilisation, Treatment, and Post treatment Follow-up.Participants will have 30 study centre visits (Screening, weekly through Run-in/Stabilisation and the first 2 weeks of treatment, followed by visits at Weeks 4, 8, 9, 12, 16, 20, 24, 28, 36, 48, 52, 65, 78, 91, 104, 116, 130, 143, and 156 [End of Treatment], and Week 164 [Follow-up]); there will also be a telephone call at Week 155.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  09/H0606/64

• Date of REC Opinion

  1 Jul 2009

• REC opinion

  Further Information Favourable Opinion