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

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Glucagon-Like Peptide 1

Criteria

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.