GLP112754 Albiglutide in participants With Type 2 Diabetes Mellitus V2

• Research type

  Research Study

• Full title

  A Randomized, Open-Label, Parallel-Group, Multicenter Study to Determine the Efficacy and Long-Term Safety of Albiglutide Compared With Insulin in Subjects With Type 2 Diabetes Mellitus

• IRAS ID

  22509

• Sponsor organisation

  GlaxoSmithKline Research and Development Ltd.

• Eudract number

  2008-007661-24

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a phase III, randomised, open-label, parallel-group, multicentre study. The purpose of this study is to evaluate whether treatment with Albiglutide is safe and can help treat people with type 2 diabetes. The study will also find out if taking albiglutide with metformin alone, or with metformin plus a sulfonylurea, is better than taking insulin glargine with metformin alone or with metformin plus a sulfonylurea. This study is also being done to see how the body absorbs, uses, and gets rid of albiglutide.It is planned that about 750 participants with type 2 diabetes, 18 years of age or older, will be in this study. Approximately 22 of these participants will be recruited in the UK. This study will last about 170 weeks, or approximately three years.The participant will be assigned by chance to 1 of the 2 study groups:<ul> <li style="color: Group 1: Albiglutide, 30 mg weekly (may be increased up to 50 mg weekly) metformin daily with or without a sulfonylurea. </li> <li style="color: Group 2: Insulin glargine metformin daily with or without a sulfonylurea.</li></ul>The study will comprise 4 study periods: Screening, Run-in, Treatment, and Post treatment Follow-up.Participants will have 28 study centre visits (Screening, weekly through Run-in 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/H0606/62

• Date of REC Opinion

  1 Jul 2009

• REC opinion

  Further Information Favourable Opinion