Phase 2 Trial of LY2428757 in patients with Type 2 Diabetes Mellitus
Research type
Research Study
Full title
A 12-Week, Double-Blind, Placebo-Controlled Trial of LY2428757 in Patients with Type 2 Diabetes Mellitus
IRAS ID
9820
Sponsor organisation
Eli Lilly and Company
Eudract number
2008-004207-63
Clinicaltrials.gov Identifier
Research summary
Type2 Diabetes Mellitus (T2DM) is a common disorder that results in high levels of sugar in the blood which, over time, can result in damage to numerous body tissues. Various oral medications have been developed for the treatment of TD2M; however patients who have been treated with oral therapeutic agents often continue to progress to a stage where insulin therapy (regular insulin injections) has to be administered. LY2428757 is a synthetic analog of glucagon-like peptide-1 (GLP-1) and is being developed by Eli Lilly and company for the treatment of T2DM. GLP-1 is a naturally occurring hormone secreted by cells in the intestine. It plays an important role in controlling blood sugar levels in humans. There is another, twice daily, injectable GLP-1 based therapy (exenatide) already available for use in type 2 diabetes. LY2428757 is expected to lower blood sugar levels in individuals with T2DM through mechanisms similar to naturally occurring GLP-1. It is intended that this investigational medicine be given once a week as a subcutaneous injection(s) (under the skin). This is a double blind, randomized, placebo-controlled study. The study will test 5 different dose levels of LY2428757 or placebo (an injection that has a similar appearance to the study drug but has no medicine) with approximately 50 patients in each group. Neither the doctor nor the patient involved in the study will know which medication has been administered.The study will enrol adult patients with T2DM whose blood sugar levels are inadequately controlled with diet and exercise alone, or in combination with metformin therapy. The objective of the study is to evaluate the safety and effectiveness of LY2428757 when given to patients once-weekly for 12 weeks.This study will take place at approximately 72 centres in 13 countries across the world.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
09/H1002/4
Date of REC Opinion
28 Apr 2009
REC opinion
Further Information Favourable Opinion