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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: May 17, 2011
Last updated: August 29, 2013
Last verified: August 2013
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.

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Vildagliptin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Measure: effect of treatment on insulin sensitivity, assessed as glucose Rd (rate of glucose disposal). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: April 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vildagliptin Drug: Vildagliptin
Dosage 50mg b.i.d.
Experimental: Placebo Drug: Placebo
50mg bid


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01356381

United Kingdom
Novartis Investigative Site
Newcastle Upon Tyne, United Kingdom, NE4 5PL
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals ) Identifier: NCT01356381     History of Changes
Other Study ID Numbers: CLAF237A2389  2006-004400-40 
Study First Received: May 17, 2011
Last Updated: August 29, 2013
Health Authority: United States: Food and Drug Administration
UK: Medicines and Healthcare products Regulatory Agency (

Keywords provided by Novartis:
Diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors processed this record on May 04, 2016