Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 diabetes, Vildagliptin, Hemoglobin A1c
Brief summary
This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic agent. This 12-week clinical study is to evaluate the effect of vildagliptin 50mg qd, 50mg bid or 100mg qd compared to placebo in patients with type 2 diabetes.
Interventions
DRUGVildagliptin
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Inclusion criteria
* Diagnosis of type 2 diabetes * Patients who have been placed on dietary therapy/exercise therapy without achievement of glycemic control * Outpatients
Exclusion criteria
* Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes * Significant cardiovascular disease * Significant diabetic complications Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline on HbA1c at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline on fasting plasma glucose at 12 weeks | — |
| Change from baseline on HOMA B at 12 weeks | — |
| Change from baseline on HOMA IR at 12 weeks | — |
| Change from baseline in body weight at 12 weeks | — |
| Change from baseline on fasting lipids at 12 weeks | — |
Countries
Japan
Outcome results
None listed