A Study To Compare the Effect of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00351832
First received: July 11, 2006
Last updated: May 7, 2007
Last verified: May 2007
  Purpose

This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic agent. This 12-week clinical study is to evaluate the effect of vildagliptin 50mg qd, 50mg bid or 100mg qd compared to placebo in patients with type 2 diabetes.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Vildagliptin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 12 Weeks Treatment With Vildagliptin (50mg qd, 50mg Bid, 100mg qd) to Placebo in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline on HbA1c at 12 weeks

Secondary Outcome Measures:
  • Change from baseline on fasting plasma glucose at 12 weeks
  • Change from baseline on HOMA B at 12 weeks
  • Change from baseline on HOMA IR at 12 weeks
  • Change from baseline in body weight at 12 weeks
  • Change from baseline on fasting lipids at 12 weeks

Estimated Enrollment: 236
Study Start Date: June 2006
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Diagnosis of type 2 diabetes
  • Patients who have been placed on dietary therapy/exercise therapy without achievement of glycemic control
  • Outpatients

Exclusion Criteria:

  • Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
  • Significant cardiovascular disease
  • Significant diabetic complications

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00351832

Locations
Japan
Novartis Pharmaceuticals
Tokyo, Japan
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00351832     History of Changes
Other Study ID Numbers: CLAF237A1303
Study First Received: July 11, 2006
Last Updated: May 7, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:
Type 2 diabetes
Vildagliptin
Hemoglobin A1c

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

ClinicalTrials.gov processed this record on April 15, 2014