Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 diabetes, vildagliptin
Brief summary
This study is not being conducted in the United States. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to acarbose in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.
Interventions
DRUGvildagliptin
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Not currently on drug therapy for type 2 diabetes * Body mass index (BMI) in the range 20-40 * Blood glucose criteria must be met
Exclusion criteria
* Pregnancy or lactation * Type 1 diabetes * Evidence of significant diabetic complications * Evidence of serious cardiovascular conditions * Laboratory value abnormalities as defined by the protocol * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c at 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c at 24 weeks for subset of Chinese patients | — |
| Overall adverse event profile after 24 weeks of treatment | — |
| Gastrointestinal side effect profiles after 24 weeks of treatment | — |
| Change from baseline in fasting plasma glucose at 24 weeks | — |
| Patients with endpoint HbA1c <7% after 24 weeks | — |
Countries
Switzerland
Outcome results
None listed