Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well Controlled With Metformin Alone

Novartis

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: metformin; Drug: Vildagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00396357

CLAF237A23104

Details and patient eligibility

About

This study is designed to evaluate the efficacy and safety of vildagliptin in combination with metformin 500 mg bid compared to metformin 1000 mg bid in patients with type 2 diabetes.

Enrollment: 914 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-78 years inclusive
• Type 2 diabetes diagnosis at least 2 months prior to study entry
• Body mass index in the range of 22-45 kg/m2
• HbA1c in the range of 6.5 to 9% inclusive
• Fasting plasma glucose <270 mg/dL (15 mmol/L)

Exclusion criteria

• A history of type 1 diabetes
• Evidence of significant diabetic complications
• Treatment with insulin or any other oral antidiabetic agents
• Congestive heart failure requiring pharmacologic treatment
• Clinically significant renal dysfunction defined by metformin labeling criteria (serum creatinine levels >/= 1.5 mg/dl (males) and >/= 1.4 mg/dl (females)

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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914 participants in 2 patient groups

vildagliptin + metformin

Experimental group

Treatment:

Drug: Vildagliptin

Metformin

Active Comparator group

Treatment:

Drug: metformin