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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014