Albiglutide with Insulin Glargine in Patients with Type 2 Diabetes

• Research type

  Research Study

• Full title

  A Randomized, Open-Label, Active-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine as Compared with the Combination of Insulin Glargine and Preprandial Lispro Insulin in Subjects With Type 2 Diabetes Mellitus

• IRAS ID

  34336

• Contact name

  Luigi Gnudi

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2009-015386-30

• ISRCTN Number

  Not Sent

• Research summary

  Type 2 diabetes is the most common form of diabetes. In sufferers, either their bodies do not produce enough insulin or their cells do not fully use the insulin produced. The body needs insulin to use sugar, which is the basic fuel for cells in the body. Insulin takes sugar from the blood into the cells. When sugar builds up in the blood, it can cause cells to starve for energy and over time, may damage the eyes, kidneys, nerves or heart. Current management of the disease consists of diet, exercise and weight reduction, together with oral anti-diabetic medicine or insulin as appropriate.A substance called GLP-1 is released in the intestine in response to food and has been shown to have effects that would be beneficial to type 2 diabetics. Native GLP-1 does not last long enough to be a suitable treatment. However, GlaxoSmithKline is developing a new drug, called albiglutide, which is a long-acting GLP-1 agonist that can be given by injection once weekly.The aim of the study is to assess how effective albiglutide is at reducing blood sugar when given in combination with insulin glargine compared to the combination of insulin glargine and preprandial lispro insulin.Participants will be randomly assigned to receive either:- albiglutide and insulin glargine- insulin glargine and preprandial lispro insulinThey have a 50% chance of being assigned to either group.About 500 participants will be enrolled, with about 18 participants from 6 clinics in the UK. The study will include screening, run-in, treatment and post-treatment follow-up with overall duration 64-68 weeks.Participants will attend the clinic approximately 17-21 times during the study. Study procedures include physical examination, visual examination, vital signs, ECG, blood and urine samples and questionnaire completion. After the study, participants will be offered appropriate treatment for their type 2 diabetes.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  09/H0713/69

• Date of REC Opinion

  20 Jan 2010

• REC opinion

  Further Information Favourable Opinion