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To Assess the Efficacy and Safety of Vildagliptin as Add-on Therapy to Sulfonylurea in Patients With Type 2 Diabetes Inadequately Controlled With Sulfonylurea Monotherapy

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00325117
First received: May 10, 2006
Last updated: May 10, 2007
Last verified: May 2007
History of Changes

May 10, 2006
May 10, 2007
April 2006
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Change from baseline to endpoint on HbA1c at 12 weeks
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Complete list of historical versions of study NCT00325117 on ClinicalTrials.gov Archive Site
  • Change from baseline to endpoint on fasting plasma glucose at 12 weeks
  • Change from baseline to endpoint in HOMA B at 12 weeks
  • Change from baseline to endpoint in HOMA IR at 12 weeks
  • Change from baseline to endpoint on fasting lipids at 12 weeks
  • Adverse events profile after 12 weeks of treatment
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To Assess the Efficacy and Safety of Vildagliptin as Add-on Therapy to Sulfonylurea in Patients With Type 2 Diabetes Inadequately Controlled With Sulfonylurea Monotherapy
A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 12 Weeks Treatment With Vildagliptin to Placebo as Add-on Therapy to Sulfonylurea in Patients With Type 2 Diabetes Inadequately Controlled With Sulfonylurea Monotherapy

This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic agent. This 12-week clinical study is designed as a multicenter, randomized, double-blind, parallel-group, placebo-controlled study aimed to evaluate the efficacy and safety of vildagliptin as add-on therapy to a sulfonylurea in patients with type 2 diabetes inadequately controlled with sulfonylurea monotherapy.
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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
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Kikuchi M, Haneda M, Koya D, Tobe K, Onishi Y, Couturier A, Mimori N, Inaba Y, Goodman M. Efficacy and tolerability of vildagliptin as an add-on to glimepiride in Japanese patients with Type 2 diabetes mellitus. Diabetes Res Clin Pract. 2010 Sep;89(3):216-23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
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Inclusion Criteria:

  • Diagnosis of type 2 diabetes and treated with a stable dose of sulfonylurea
  • Patients on diet and exercise who have not reached target blood glucose levels
  • Outpatients

Exclusion Criteria:

  • Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
  • Significant cardiovascular complications as defined by the protocol
  • Significant diabetic complications as defined by the protocol

Other protocol-defined inclusion/exclusion criteria may apply.
Both
20 Years and older
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Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00325117
CLAF237A1302
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Novartis
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2007

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