Diabetes Mellitus Type 2
Conditions
Brief summary
This 6 arm study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of multiple doses and regimens of a GLP-1 analogue in patients with type 2 diabetes who are treated with a stable dose of metformin. Patients will be randomized to receive either subcutaneous placebo, or subcutaneous GLP-1 analogue, 5mg, 10mg or 20mg weekly, or 10mg or 20mg every 2 weeks. All patients will continue on their existing metformin treatment regimen throughout the study. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.
Interventions
DRUGPlacebo
sc weekly
DRUGtaspoglutide
20mg sc weekly
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, with stable metformin treatment for \>=3 months; * stable weight +/-10% for \>=3 months before screening.
Exclusion criteria
* type 1 diabetes mellitus; * treatment with any anti-hyperglycemic medication other than metformin monotherapy during last 3 months; * use of weight-lowering medications in the last 3 months; * uncontrolled hypertension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change from baseline in HbAlc | Week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Absolute change from baseline in FPG, fructosamine, body weight, fasting insulin, C-peptide, glucagon. | Week 8 |
| Changes in lipid profile | Week 8 |
| AEs, laboratory parameters, primary pharmacokinetic parameters | Throughout study |
Countries
Australia, Bulgaria, Germany, Guatemala, Hong Kong, Latvia, Lithuania, Mexico, Romania, United States
Outcome results
None listed