Evaluation of effect of LY2189265 on gastric emptying in T2DM patients

• Research type

  Research Study

• Full title

  A Study to Evaluate the Effect of LY2189265 on Gastric Emptying Using Scintigraphy in Patients with Type 2 Diabetes Mellitus

• IRAS ID

  57085

• Contact name

  Alan G Wade

• Sponsor organisation

  Eli Lilly and Company Ltd

• Eudract number

  2009-017305-11

• Clinicaltrials.gov Identifier

  01215968

• Research summary

  LY2189265 is a new potential treatment which is being developed by Eli Lilly and Company Ltd with an aim to help people with type 2 diabetes mellitus in the future.Glucagon-like peptide-1 (GLP-1) is a natural protein secreted in the body after meal consumption that helps the body control the blood sugar levels. GLP-1 only works for a few minutes after each meal which is usually sufficient. LY2189265 works in a similar way to GLP-1 but it is longer acting and therefore it is hoped that it will help control blood sugar levels for longer in diabetic patients who are unable to control their own blood sugar levels naturally. Some diabetic patients in this Study may take metformin medication to control their diabetes. One of the aims of this research is to learn more about how LY2189265 affects how the body handles metformin in these patients. In this study, we will be looking at:?½ How LY2189265 affects gastric emptying in patients with diabetes?½ How LY2189265 affects how the body handles metformin?½ The safety profile of LY2189265 and if there are any side effects associated with itTo look at these parameters, we will add small amounts of radioactive material to a weekly breakfast consumed by the study patients. This breakfast will be given approximately 2 days after each dose of LY2189265 or placebo. The radiation emitted will be detected outside the body by a device known as a gamma camera. We will also take blood samples to allow us to measure the levels of LY2189265 and metformin in the bloodstream. Only type 2 diabetic patients who fulfil certain criteria will be recruited into this study, which will last about 8 months in total, but each patient will only be involved for approximately 11 to 13 weeks.

• REC name

  West of Scotland REC 1

• REC reference

  10/S0703/43

• Date of REC Opinion

  26 Aug 2010

• REC opinion

  Further Information Favourable Opinion