Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00101673
First received: January 12, 2005
Last updated: May 4, 2012
Last verified: May 2012

January 12, 2005
May 4, 2012
March 2004
June 2005   (final data collection date for primary outcome measure)
Change from baseline in HbA1c at 12 weeks
Blood glucose levels
Complete list of historical versions of study NCT00101673 on ClinicalTrials.gov Archive Site
  • Adverse event profile after 12 weeks of treatment
  • Patients with reduction in HbA1c >/= 0.7% after 12 weeks
  • Change from baseline in fasting plasma glucose at 12 weeks
  • Change from baseline in HOMA-B at 12 weeks
  • Change from baseline in body weight at 12 weeks
Not Provided
Not Provided
Not Provided
 
Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%
Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%

This study was not conducted in the United States. The purpose of this study was 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.

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
251
June 2005
June 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy or lactation
  • 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 and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00101673
CLAF237A2329
Not Provided
Novartis ( Novartis Pharmaceuticals )
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