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A Clinical 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:
Novartis
ClinicalTrials.gov Identifier:
NCT00099905
First received: December 21, 2004
Last updated: May 1, 2012
Last verified: May 2012

December 21, 2004
May 1, 2012
April 2004
October 2005   (final data collection date for primary outcome measure)
Change from baseline in HbA1c at 24 weeks
Blood glucose level
Complete list of historical versions of study NCT00099905 on ClinicalTrials.gov Archive Site
  • Change from baseline in fasting plasma glucose at 24 weeks
  • Patients with endpoint HbA1c <7% after 24 weeks
  • Patients with reduction in HbA1c>/=to 0.7% after 24 weeks
  • Change from baseline in body weight at 24 weeks
  • Change from baseline in fasting lipids at 24 weeks
Not Provided
Not Provided
Not Provided
 
A Clinical Study to Assess the Efficacy and Safety of Three Doses of Vildagliptin in Patients With Type 2 Diabetes
A Clinical Study to Assess the Efficacy and Safety of Three Doses of Vildagliptin in Patients With Type 2 Diabetes

The purpose of this study is to assess 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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: vildagliptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
639
October 2005
October 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Body mass index (BMI) in the range 22-45
  • Blood glucose criteria must be met
  • Not currently on drug therapy for type 2 diabetes

Exclusion Criteria:

  • Type 1 diabetes
  • Evidence of serious diabetic complications
  • Evidence of serious cardiovascular conditions
  • Laboratory value abnormalities as defined by the protocol
  • Other protocol-defined exclusion criteria may apply
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00099905
CLAF237A2301
Not Provided
Not Provided
Novartis Pharmaceuticals
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