Effect of Injection site and BMI on the Bioavailability of LY2189265
Research type
Research Study
Full title
The Effect of Injection Site on the Relative Bioavailability of LY2189265 in Subjects with Low and High Body Mass Index
IRAS ID
45744
Contact name
Ashley Brooks
Sponsor organisation
Eli Lilly and Company
Eudract number
2009-017233-21
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
Glucagon-like peptide-1 (GLP-1) is hormone secreted by intestinal cells, which helps reduce glucose levels in blood. LY2189265 is a new drug under development, which is similar to GLP-1 but has a longer duration of action. It is being developed for use in patients with Diabetes to improve control of blood sugar. As of 4th September 2009, approximately 437 people (157 healthy subjects and 280 patients with type 2 diabetes) have taken LY2189265 in 7 completed or concluded studies. This study involves single injections of 1.5 mg of LY2189265 under the skin of the arm, thigh and abdomen in healthy male and female volunteers. Up to 50 subjects will be categorized into two main groups based on their Body Mass Index (BMI) ie. Low BMI group and high BMI group. Subjects in each group will be randomised to receive a single injection of LY2189265 in the arm, thigh and abdomen over three treatment periods. In each treatment period, subjects will be admitted to the research unit on the day before the injection is given (Day-1), to Day 3 (approximately 48 hours after injection) and return to the research unit on Days 4, 6, 8, and 15 for blood sampling as nonresidential visits. There will be a washout period of 28 days between two doses of LY2189265. The follow-up visit will occur at least 21 days after the last dose of LY2189265. The study will run over a period of approximately 14 weeks.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
10/IEC05/3
Date of REC Opinion
30 Mar 2010
REC opinion
Further Information Favourable Opinion