Efficacy and Safety of Vildagliptin Compared to Metformin in Elderly Drug Naive Patients With Type 2 Diabetes

Novartis

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Vildagliptin 100 mg qd; Drug: Metformin 1500 mg daily

Study type: Interventional

Funder types: Industry

Identifiers

NCT00383578

CLAF237A2398

Details and patient eligibility

About

This study is designed to demonstrate the efficacy and safety of vildagliptin compared to metformin in elderly drug naive patients with type 2 diabetes

Enrollment: 335 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age from 65 years to the upper age limit recommended by local prescribing information for metformin
• Drug naive patients with type 2 diabetes.
• Body mass index (BMI) in the range of 22-40 kg/m2.
• HbA1c in the range of 7 to 9% inclusive
• FPG <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

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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335 participants in 2 patient groups

Vildagliptin

Experimental group

Treatment:

Drug: Vildagliptin 100 mg qd

Metformin

Active Comparator group

Treatment:

Drug: Metformin 1500 mg daily