Efficacy of add-on Therapy With Vildagliptin in Chinese Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy

Novartis

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Vildagliptin 50 mg bid; Drug: Vildagliptin 50 mg qd

Study type: Interventional

Funder types: Industry

Identifiers

NCT00822211

CLAF237A23140

Details and patient eligibility

About

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.

Enrollment: 404 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

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/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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404 participants in 3 patient groups, including a placebo group

Vildagliptin Dose 1

Experimental group

Treatment:

Drug: Vildagliptin 50 mg bid

Vildagliptin Dose 2

Experimental group

Treatment:

Drug: Vildagliptin 50 mg qd

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo