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A 56-Week Extension to a Clinical Study to Assess the Efficacy and Safety of Vildagliptin Compared to Placebo in Drug Naive Patients With Type 2 Diabetes and Mild Hyperglycemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00300287
First Posted: March 8, 2006
Last Update Posted: August 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
March 6, 2006
March 8, 2006
August 2, 2017
February 20, 2006
June 26, 2007   (Final data collection date for primary outcome measure)
Change from baseline in HbA1c at 108 weeks
Not Provided
Complete list of historical versions of study NCT00300287 on ClinicalTrials.gov Archive Site
  • Adverse event profile after 108 weeks of treatment
  • Change in HbA1c from week 52 to week 108
  • Change from baseline in fasting plasma glucose at week 108
  • Change in fasting plasma glucose from week 52 to week 108
  • Change from baseline in body weight at week 108
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A 56-Week Extension to a Clinical Study to Assess the Efficacy and Safety of Vildagliptin Compared to Placebo in Drug Naive Patients With Type 2 Diabetes and Mild Hyperglycemia
A 56-Week Extension to a Clinical Study to Assess the Efficacy and Safety of Vildagliptin Compared to Placebo in Drug Naive Patients With Type 2 Diabetes and Mild Hyperglycemia
This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to gather data on the long-term safety and effectiveness 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 and whose blood glucose levels are close to normal.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: Vildagliptin
Not Provided
Scherbaum WA, Schweizer A, Mari A, Nilsson PM, Lalanne G, Wang Y, Dunning BE, Foley JE. Evidence that vildagliptin attenuates deterioration of glycaemic control during 2-year treatment of patients with type 2 diabetes and mild hyperglycaemia. Diabetes Obes Metab. 2008 Nov;10(11):1114-24. doi: 10.1111/j.1463-1326.2008.00875.x. Epub 2008 Mar 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
June 26, 2007
June 26, 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Completion of study CLAF237A2307 within 4 weeks of entering into the extension
  • Written informed consent
  • Ability to comply with all study requirements
  • Blood glucose criteria must be met

Exclusion Criteria:

  • Premature discontinuation from study CLAF237A2307
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
Not Provided
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00300287
CLAF237A2307E1
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Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
July 2017

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