Study to Assess the Effect of 24 Weeks of Treatment With Vildagliptin in Patients With Type 2 Diabetes

Novartis

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Vildagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01356381

2006-004400-40 (EudraCT Number)

CLAF237A2389

Details and patient eligibility

About

The study will demonstrate the effect of 24 weeks of treatment with vildagliptin compared to placebo on insulin sensitivity in patients with type 2 diabetes mellitus (T2DM) treated with metformin, assessed as glucose Rd (rate of glucose disposal) during a hyperinsulinemic euglycemic clamp.

Enrollment: 43 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age in the range of 18-70 years.
2. Patients with T2DM, diagnosed at least 6 months prior to Visit 1, who have received metformin for at least 3 months and have been on a stable dose of at least 1000mg daily for a minimum of 4 weeks prior to Visit 1.
3. HbA1c ≤ 7.6% at Visit 1.
4. Body mass index (BMI) in the range of 22-38kg/m2 inclusive at Visit 1.

Exclusion criteria

1. Pregnant or nursing (lactating) women.
2. Patients with cardiac pacemakers or with metallic implants incompatible with magnetic resonance methodology.
3. Congestive heart failure requiring pharmacologic treatment. Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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43 participants in 2 patient groups

vildagliptin

Experimental group

Treatment:

Drug: Vildagliptin

Placebo

Experimental group

Treatment:

Drug: Placebo