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
  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:


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
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: 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 August 27, 2014