A Study of the Effect of Taspoglutide on Gastric Emptying in Patients With Type 2 Diabetes

A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Investigate the Effect of Taspoglutide on Gastric Emptying Measured by a Paracetamol Test After Single Dose and After Multiple Doses in Patients With Type 2 Diabetes

This 3 arm, placebo-controlled study will investigate the effect of Taspoglutide on gastric emptying in patients with type 2 diabetes. Patients will be randomized into one of 3 groups to receive a)10mg Taspoglutide sc weekly for 12 weeks b)10mg Taspoglutide sc weekly for 4 weeks followed by 20mg Taspoglutide sc weekly for 8 weeks or c) placebo sc weekly for 12 weeks, with all injections administered in the abdomen.Gastric emptying will be assessed by a paracetamol test at intervals during the study. The anticipated time on study treatment is 3 months, and the target sample size is <100 individuals.

Inclusion Criteria:

• adult patients, 18-75 years of age;
• type 2 diabetes mellitus, treated with stable oral antidiabetic drug therapy for >=3 months prior to screening;
• stable weight +/-10% for >=3 months before screening.

Exclusion Criteria:

• type 1 diabetes mellitus;
• acute gastrointestinal symptoms at screening and/or day -1;
• clinically relevant cardiovascular, bronchopulmonary, gastrointestinal or neurological disease.