Diabetes Mellitus, Type 2
Conditions
Keywords
type 2 diabetes, vildagliptin
Brief summary
This study was not conducted in the United States. The purpose of this study was to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not previously been treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a specified range.
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
* Blood glucose criteria must be met * Not currently on drug therapy for type 2 diabetes * Body mass index (BMI) in the range 22-45
Exclusion criteria
* Pregnancy or lactation * Type 1 diabetes * Evidence of serious 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 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event profile after 12 weeks of treatment | — |
| Patients with reduction in HbA1c >/= 0.7% after 12 weeks | — |
| Change from baseline in fasting plasma glucose at 12 weeks | — |
| Change from baseline in HOMA-B at 12 weeks | — |
| Change from baseline in body weight at 12 weeks | — |
Countries
Switzerland
Outcome results
None listed