Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus, HbA1c reduction, vildagliptin, add-on to metformin, Chinese patients
Brief summary
The purpose of this study is to assess the efficacy and safety of vildagliptin 50 mg bid compared to placebo as an add-on therapy to metformin in Chinese patients with T2DM inadequately controlled by metformin alone.
Interventions
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 78 Years
Healthy volunteers
No
Inclusion criteria
* Patients with T2DM who have received metformin for at least 8 weeks and have been on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1 * Agreement to maintain the same dose of metformin from randomization to the end of the study * Age in the range of 18-78 years inclusive * Body mass index (BMI) in the range of 20-40 kg/m2 inclusive at Visit 1 * HbA1c in the range of \> 7.0 to ≤10% at Visit 1 * Agreement to maintain prior diet and exercise habits during the full course of the study * Ability to comply with all study requirements
Exclusion criteria
* Fasting Plasma Glucose (FPG) \> 270 mg/dl (15 mmol/L) at Visit 1 * Pregnant or nursing (lactating) women Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c after 24 weeks | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percent of patients with HbA1c < 7% after 24 weeks | 24 weeks |
| Adverse event profile after 24 weeks of treatment | 24 weeks |
| Change from baseline in fasting plasma glucose at 24 weeks | 24 weeks |
Countries
China
Outcome results
None listed