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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

August 27, 2005
May 4, 2012
July 2004
July 2006   (final data collection date for primary outcome measure)
  • Safety in combination with pioglitizone after 52 weeks of treatment
  • Change from baseline in HbA1c at 52 weeks
  • HbA1c
  • Safety and tolerability measures
Complete list of historical versions of study NCT00138593 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
Extension to a Study of the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With Hemoglobin A1c (HbA1c) 9-11%
Extension to a Study of the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%

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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: vildagliptin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
July 2006
July 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00138593
CLAF237A2329E1
Not Provided
Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP