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Vildagliptin Glycemic Profiles Assessment Using a Continuous Glucose Monitoring Device.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01262586
First Posted: December 17, 2010
Last Update Posted: November 18, 2016
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 (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
December 16, 2010
December 17, 2010
November 18, 2016
November 2010
March 2011   (Final data collection date for primary outcome measure)
Change in Glycemic profiles between vildagliptin and glimepiride [ Time Frame: Baseline and treatment Day 5, 24hr continuous glucose measurements ]
Same as current
Complete list of historical versions of study NCT01262586 on ClinicalTrials.gov Archive Site
Glucose Fluctuation before and during treatment [ Time Frame: Baseline and treatment Day 5, 24hr continuous measurements ]
Same as current
Not Provided
Not Provided
 
Vildagliptin Glycemic Profiles Assessment Using a Continuous Glucose Monitoring Device.
Pilot Study to Assess the Difference in Glycemic Profiles Between Vildagliptin and Glimepiride Using Continuous Glucose Monitoring Device
This study will use Continuous Glucose Monitoring to assess differences in glycemic profiles between vildagliptin and glimepiride.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Type II Diabetes Mellitus
  • Drug: Vildagliptin
  • Drug: Glimepiride
  • Experimental: Vildagliptin
    Intervention: Drug: Vildagliptin
  • Active Comparator: Glimepiride
    Intervention: Drug: Glimepiride
He YL, Foteinos G, Neelakantham S, Mattapalli D, Kulmatycki K, Forst T, Taylor A. Differential effects of vildagliptin and glimepiride on glucose fluctuations in patients with type 2 diabetes mellitus assessed using continuous glucose monitoring. Diabetes Obes Metab. 2013 Dec;15(12):1111-9. doi: 10.1111/dom.12146. Epub 2013 Jul 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
March 2011
March 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes patients on stable metformin
  • 18-70 years old
  • Willing to perform at least 4 capillary blood glucose tests per day

Exclusion Criteria:

  • Type 2 diabetes patients on any other antidiabetic treatment
  • Patients listed in other trials
  • Patients with significant diabetic organ disease or complications.

Other protocol-defined inclusion/exclusion criteria may apply

Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01262586
CLAF237A23151
2010-021236-34 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2016

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