GLP112753.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 When Used in Combination With Metformin Compared With Metformin Plus Sitagliptin, Metformin Plus Glimepiride, and Metformin Plus Placebo in Subjects With Type 2 Diabetes Mellitus

• IRAS ID

  22508

• Sponsor organisation

  GlaxoSmithKline Research and Development Ltd.

• Eudract number

  2008-007660-41

• 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 people with type 2 diabetes. This study will also evaluate if taking albiglutide with metformin is better than taking metformin alone, metformin with sitagliptin, or metformin with glimepiride. Participants will continue using their current metformin medicine during the study. It is planned that about 1000 participants with type 2 diabetes, 18 years of age or older, will be recruited into the study. Approximately 30 of these participants will be in the UK. This study will last about last about 170 weeks, or approximately three years. The participant will be assigned by chance to 1 of the 4 study groups: <ul> <li style="color: Group 1: Albiglutide 30 mg weekly (may be increased up to 50 mg weekly) metformin daily sitagliptin matching placebo daily glimepiride matching placebo daily</li> <li style="color: Group 2: Albiglutide matching placebo weekly metformin daily sitagliptin 100 mg daily glimepiride matching placebo daily</li> <li style="color: Group 3: Albiglutide matching placebo weekly metformin daily sitagliptin matching placebo daily glimepiride 2 mg daily (may be increased up to 4 mg daily)</li> <li style="color: Group 4: Albiglutide matching placebo weekly metformin daily sitagliptin matching placebo daily glimepiride 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 26 study centre visits (Screening, weekly through Run- in/Stabilisation and the first 2 weeks of treatment, followed by visits at Weeks 4, 8, 12, 16, 20, 24, 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/H0606/61

• Date of REC Opinion

  1 Jul 2009

• REC opinion

  Further Information Favourable Opinion