Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 diabetes, vildagliptin
Brief summary
The purpose of this study is to assess the long term safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.
Interventions
DRUGvildagliptin
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Not currently on drug therapy for type 2 diabetes * Blood glucose criteria must be met * Body mass index (BMI) in the range 22-45
Exclusion criteria
* History of type 1 diabetes * Evidence of significant diabetic complications * Serious cardiovascular events within the past 6 months * 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 |
|---|---|
| Adverse event profile after 24 weeks of treatment | — |
| Change from baseline in fasting plasma glucose at 24 weeks | — |
| Patients with endpoint HbA1c < 7% after 24 weeks | — |
| Patients with reduction in HbA1c >/= 0.7% after 24 weeks | — |
| Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs. low baseline HbA1c | — |
Countries
United States
Outcome results
None listed