A Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin Plus Metformin

Novartis

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: vildagliptin + metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00468039

CLMF237A2302S1

Details and patient eligibility

About

This study will evaluate the effects of treatment with vildagliptin and metformin as initial combination in newly diagnosed patients with type 2 diabetes who have very high levels of HbA1c and/or fasting plasma glucose.

Enrollment: 94 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

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 type 2 diabetes for at least 4 weeks prior to study entry
• Body mass index 22-40 kg/meter squared
• HbA1c > 11% and/or FPG >270 mg/dL

Exclusion criteria

• Pregnant or lactating female
• History of type 1 diabetes
• Evidence of significant diabetic complications
• Treatment with insulin or any other oral antidiabetic agent

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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94 participants in 1 patient group

vildagliptin + metformin

Experimental group

Treatment:

Drug: vildagliptin + metformin