Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 diabetes, vildagliptin, metformin, hemoglobin A1c
Brief summary
The purpose of this study is to evaluate the efficacy and safety of a fixed combination of vildagliptin and metformin in lowering blood glucose in patients with type 2 diabetes
Interventions
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 78 Years
Healthy volunteers
No
Inclusion criteria
* Male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes * Diagnosis of T2DM for at least 4 weeks prior to study entry * Age 18 - 78 years inclusive * Body mass index (BMI) of 22 - 40 kg/m2 * HbA1c: 7.5 - 11% inclusive * FPG \<270 mg/dL (15 mmol/L)
Exclusion criteria
* Pregnant or lactating female * A history of type 1 diabetes * Evidence of significant diabetic complications * Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c | At week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in fasting plasma glucose | At week 24 |
| Percent of patients with endpoint HbA1c <7% | At week 24 |
| Percent of patients with reduction in HbA1c >/=0.7% | At week 24 |
| Adverse event profile after treatment | At week 24 |
| Change from baseline in body weight | At week 24 |
Countries
Germany, United States
Outcome results
None listed