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Extension to a Study of the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With Hemoglobin A1c (HbA1c) 9-11%

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00138593
First received: August 27, 2005
Last updated: May 4, 2012
Last verified: May 2012
History of Changes
  Purpose

This study is not being conducted in the United States. This is a 52-week extension to a study to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not previously been treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a specified range. The purpose of the extension study is to gather data on the long term safety and effectiveness of vildagliptin in people with type 2 diabetes.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extension to a Study of the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety in combination with pioglitizone after 52 weeks of treatment
  • Change from baseline in HbA1c at 52 weeks

Secondary Outcome Measures:
  • Change from baseline in fasting plasma glucose at 52 weeks
  • Change from baseline in fasting lipids at 52 weeks
  • Change from baseline in body weight at 52 weeks
  • Change from baseline in HOMA B at 52 weeks
  • Change from baseline in HOMA IR at 52 weeks

Estimated Enrollment: 180
Study Start Date: July 2004
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Only patients successfully completing study CLAF237A2329 are eligible
  • Written informed consent
  • HbA1c reduction from baseline to week 12 (visit 5) of the core study is greater than or equal to 0.3 absolute units
  • Ability to comply with all study requirements

Exclusion Criteria:

  • Premature discontinuation from study CLAF237A2329
  • Other protocol-defined exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00138593

Locations
Switzerland
Novartis Pharmaceuticals
Basel, Switzerland
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00138593     History of Changes
Other Study ID Numbers: CLAF237A2329E1
Study First Received: August 27, 2005
Last Updated: May 4, 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 June 17, 2013