Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00099931
First received: December 21, 2004
Last updated: May 4, 2012
Last verified: May 2012

December 21, 2004
May 4, 2012
May 2004
June 2005   (final data collection date for primary outcome measure)
Change from baseline in HbA1c at 24 weeks
Blood glucose levels
Complete list of historical versions of study NCT00099931 on ClinicalTrials.gov Archive Site
  • Change from baseline in fasting plasma glucose at 24 weeks
  • Adverse event profile after 24 weeks of treatment
  • Change from baseline in mean daily insulin dose at 24 weeks
  • Change from baseline in mean daily number of insulin injections at 24 weeks
  • Patients with endpoint <7% after 24 weeks
Not Provided
Not Provided
Not Provided
 
Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes
Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes

Many people with type 2 diabetes cannot maintain their target blood glucose levels on a single therapy. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to insulin in people with type 2 diabetes who are not at target blood glucose levels on insulin alone.

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
Fonseca V, Schweizer A, Albrecht D, Baron MA, Chang I, Dejager S. Addition of vildagliptin to insulin improves glycaemic control in type 2 diabetes. Diabetologia. 2007 Jun;50(6):1148-55. Epub 2007 Mar 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
254
June 2005
June 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Blood glucose criteria must be met
  • On a stable dose of insulin as defined by the protocol
  • Body mass inde (BMI) in the range 22-45

Exclusion Criteria:

  • Type 1 diabetes
  • Pregnancy or lactation
  • Evidence of serious diabetic complications
  • Evidence of serious cardiovascular complications
  • Laboratory value abnormalities as defined by the protocol
  • Other protocol defined exclusion criteria may apply
Both
18 Years to 80 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00099931
CLAF237A2311
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