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A Clinical Study to Assess the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00238498
Recruitment Status : Completed
First Posted : October 13, 2005
Last Update Posted : May 2, 2012
Sponsor:
Information provided by:

Study Description
Brief Summary:
This study was not conducted in the United States. The purpose of this study was to assess the safety and effectiveness of a number of doses of vildagliptin, an unapproved drug, in the treatment of people with type 2 diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: vildagliptin Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 291 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Clinical Study to Assess the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes
Study Start Date : July 2004
Primary Completion Date : June 2005
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in HbA1c at 12 weeks

Secondary Outcome Measures :
  1. Change from baseline for postprandial glucose at 12 weeks
  2. Change from baseline on fasting plasma glucose at 12 weeks
  3. Change from baseline on postprandial glucose AUC at 12 weeks
  4. Change from baseline in HOMA B at 12 weeks
  5. Change from baseline in HOMA IR at 12 weeks

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Diagnosis of type 2 diabetes
  • Patients who have been placed on diet and 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 diseases
  • Significant diabetic complications
  • Other protocol-defined exclusion criteria may apply
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00238498


Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information

ClinicalTrials.gov Identifier: NCT00238498     History of Changes
Other Study ID Numbers: CLAF237A1202
First Posted: October 13, 2005    Key Record Dates
Last Update Posted: May 2, 2012
Last Verified: April 2012

Keywords provided by Novartis:
Type 2 diabetes
vildagliptin
HbA1c

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
Hypoglycemic Agents
Physiological Effects of Drugs