Efficacy of Fixed Combination Therapy of Vildagliptin and Metformin Compared to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes

Novartis

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Vildagliptin + Metformin; Drug: Vildagliptin; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00382096

CLMF237A2302

Details and patient eligibility

About

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

Enrollment: 1,179 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,179 participants in 4 patient groups

Vildagliptin + Metformin Dose 1

Experimental group

Treatment:

Drug: Vildagliptin + Metformin

Vildagliptin + Metformin Dose 2

Experimental group

Treatment:

Drug: Vildagliptin + Metformin

Vildagliptin

Active Comparator group

Treatment:

Drug: Vildagliptin

Metformin

Active Comparator group

Treatment:

Drug: Metformin