Extension to a Study to Assess the Efficacy and Safety of Three Doses of Vildagliptin in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00138541
First received: August 27, 2005
Last updated: May 1, 2012
Last verified: May 2012
  Purpose

This is a 28-week extension to a study of the safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar. The purpose of the extension study is to gather long-term safety and efficacy data for vildagliptin in people with type 2 diabetes.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Extension to a Study to Assess the Efficacy and Safety of Three Doses of Vildagliptin in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety of vildagliptin during 52 weeks of treatment
  • Change from baseline in HbA1c at 52 weeks

Secondary Outcome Measures:
  • Change in HbA1c between 24 weeks and 52 weeks
  • Change from baseline in fasting plasma glucose at 52 weeks
  • Change in fasting plasma glucose between 24 weeks and 52 weeks
  • Change from baseline in HOMA B at 52 weeks
  • Change from baseline in HOMA IR at 52 weeks

Enrollment: 440
Study Start Date: October 2004
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Only patients successfully completing study CLAF237A2301 are eligible
  • Written informed consent
  • Ability to comply with all study requirements

Exclusion Criteria:

  • Premature discontinuation from study CLAF237A2301
  • Other protocol-defined 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: NCT00138541

Locations
United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00138541     History of Changes
Other Study ID Numbers: CLAF237A2301E1
Study First Received: August 27, 2005
Last Updated: May 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
type 2 diabetes
vildagliptin

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 September 18, 2014