Diabetes Mellitus Type 2
Conditions
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.
Interventions
DRUGPlacebo
sc once weekly for 12 weeks
DRUGtaspoglutide
10mg sc once weekly for 4 weeks, followed by 20mg sc once weekly for 8 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tmax, log (AUC), log(Cmax)of paracetamol | Days -1, 1, 5, 29, 33, 78 and 82 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Germany, United Kingdom
Outcome results
None listed