GLP112755.Albiglutide in participants With Type 2 Diabetes Mellitus V2

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide When Used in Combination With Pioglitazone With or Without Metformin in Subjects with Type 2 Diabetes Mellitus

• IRAS ID

  22510

• Sponsor organisation

  GlaxoSmithKline Research and Development Ltd.

• Eudract number

  2008-007662-37

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a phase III, randomised, double-blind, placebo-controlled, 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 evaluate if taking albiglutide with other diabetic medications such as pioglitazone (Actos), with or without metformin, is better than taking pioglitazone alone, with or without metformin. It is planned that about 300 participants, 18 years of age or older with type 2 diabetes will be recruited into the study. Approximately 10 of these participants will be in the UK. This study will last about 170 weeks, or approximately three years. The participant will be randomly assigned by chance to 1 of the 2 study groups:<ul> <li style="color: Group 1: Albiglutide, 30 mg weekly, plus pioglitazone with or without metformin.</li> <li style="color: Group 2: Albiglutide matching placebo (an injector pen that looks like albiglutide, but with no active ingredient) plus pioglitazone with or without metformin.</li></ul>The study will comprise 4 study periods: Screening, Run-in/Stabilisation, Treatment, and Post treatment Follow-up. Participants will have 26 study center 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/H0606/63

• Date of REC Opinion

  1 Jul 2009

• REC opinion

  Further Information Favourable Opinion