AWARD-3:Assessment of Weekly Administration of LY2189265 in Diabetes-3

• Research type

  Research Study

• Full title

  The Impact of LY2189265 versus Metformin on Glycemic Control in Early Type 2 Diabetes Mellitus (AWARD-3: Assessment of Weekly AdministRation of LY2189265 in Diabetes-3)

• IRAS ID

  49339

• Contact name

  Patrick Wright

• Sponsor organisation

  Eli Lilly & Company Ltd

• Eudract number

  2009-014841-10

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  The purpose of this study is to compare control of blood sugar using two different doses of LY2189265 (1.5 mg and 0.75 mg) with the current standard oral treatment, metformin, in patients who have type 2 diabetes mellitus. The study has 3 areas as shown below. Approximately 753 patients will take part. Patients will be randomly assigned into the 3 areas by a computer system using a ratio of 1:1:1. Neither the patient nor the study doctor will know which treatment they receive.1: LY2189265 injection (0.75 mg/week) oral placebo tablets (daily)2: LY2189265 injection (1.5 mg/week) oral placebo tablets (daily)3: Metformin tablet(s) (daily) placebo injection (weekly)The study consists of 3 periods: a 2 week lead-in period, followed by a 52 week treatment period, followed by a 4 week safety follow-up period. Type 2 diabetes mellitus is a progressive illness due to the body gradually losing the ability to make and utilize insulin. Glucagon-like peptide 1 (GLP-1) is a hormone made by the gut when food is eaten.GLP-1 improves the release of insulin by the body. The study drug LY2189265 is a chemical which acts like the natural hormone GLP-1.Metformin is the current standard treatment for type 2 diabetes mellitus.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  10/H1010/23

• Date of REC Opinion

  15 Jul 2010

• REC opinion

  Further Information Favourable Opinion