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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site

Newcastle upon Tyne, NE4 5PL, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age in the range of 18-70 years.
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.
HbA1c ≤ 7.6% at Visit 1.
Body mass index (BMI) in the range of 22-38kg/m2 inclusive at Visit 1.

Exclusion criteria

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

Treatment and study plan

Vildagliptin

Drug

Dosage 50mg b.i.d.

Placebo

Drug

50mg bid

Primary outcomes

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

Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Single-center,Double-blind,Randomised,Placebo-controlled,Parallel-group Study to Assess the Effect of 24 Weeks of Treatment With Vildagliptin on Insulin Sensitivity and Its Underlying Mechanism in Patients With T2DM Treated With Metformin

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: May 19, 2011
Registry last updated: Aug 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed