A Study of the Effect of Taspoglutide on Gastric Emptying in Patients With Type 2 Diabetes
- Registration Number
- NCT00809705
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 taspoglutide - 3 Placebo - 1 taspoglutide -
- Primary Outcome Measures
Name Time Method Tmax, log (AUC), log(Cmax)of paracetamol Days -1, 1, 5, 29, 33, 78 and 82
- Secondary Outcome Measures
Name Time Method Adverse events, laboratory parameters, vital signs Throughout study renal function (creatinine clearance, urine volume and electrolytes) Throughout study Multiple dose pharmacokinetics of Taspoglutide Throughout study