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

Novartis Pharmaceuticals43 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

VildagliptinDRUG

Dosage 50mg b.i.d.

PlaceboDRUG

50mg bid

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Novartis Investigative Site

Newcastle upon Tyne, United Kingdom

Outcomes

Primary Outcomes

Measure: effect of treatment on insulin sensitivity, assessed as glucose Rd (rate of glucose disposal).

Time frame: 24 weeks

Data from ClinicalTrials.gov

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