GLP114179: Open label Albiglutide vs Liraglutide in type 2 diabetes

• Research type

  Research Study

• Full title

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

• IRAS ID

  53973

• Contact name

  Luigi Gnudi

• Eudract number

  2010-019690-15

• ISRCTN Number

  ISRCTN

• Research summary

  This is a randomized, open-label, multicentre, 2 parallel-group study to measure the efficacy and safety of a weekly subcutaneously injected dose of a new experimental drug called albiglutide compared to a licensed drug called liraglutide, which is injected daily. Participants aged 18 or older, with type 2 diabetes, whose blood sugar is inadequately controlled on their current treatment of metformin, thiazolidinedione (TZD), sulfonylurea (SU), or any combination of these oral antidiabetics will be recruited into the study. Participants will continue on their current regimen of oral antidiabetic medication for the duration of the study; some participants receiving SU may have their SU dose changed. The study is comprised of 4 periods: Screening, Run-in/Stabilization, Treatment and Post-treatment Follow-up. During the screening visit, informed consent and medical history will be obtained. Study tests will include: an eligibility assessment, physical examinations, vital signs, blood and urine tests, electrocardiogram & pregnancy tests. Eligible participants will enter the 4-week Run-in Period. At the end of the Run-in Period, the participant's HbA1c is measured (this test measures blood sugar control over time) and the results must be between 7.0% and 10.0% for the participant to be eligible for the study. Approximately 800 people worldwide will be randomly assigned to one of the following 2 groups ?½ Group 1: Albiglutide 30 mg weekly injection (increased to 50 mg weekly) ?½ Group 2: Liraglutide 0.6 mg daily injection (increased to 1.2 mg and then to 1.8 mg) Study participation will last approximately 46 weeks, during this time there will be 16 study visits each lasting between 1-4 hours. The study is sponsored by GlaxoSmithKline.

• REC name

  London - Central Research Ethics Committee

• REC reference

  10/H0718/45

• Date of REC Opinion

  8 Jul 2010

• REC opinion

  Favourable Opinion