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Vildagliptin Glycemic Profiles Assessment Using a Continuous Glucose Monitoring Device.

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.
 
ClinicalTrials.gov Identifier: NCT01262586
Recruitment Status : Completed
First Posted : December 17, 2010
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE December 16, 2010
First Posted Date  ICMJE December 17, 2010
Last Update Posted Date November 18, 2016
Study Start Date  ICMJE November 2010
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2010)
Change in Glycemic profiles between vildagliptin and glimepiride [ Time Frame: Baseline and treatment Day 5, 24hr continuous glucose measurements ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2010)
Glucose Fluctuation before and during treatment [ Time Frame: Baseline and treatment Day 5, 24hr continuous measurements ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vildagliptin Glycemic Profiles Assessment Using a Continuous Glucose Monitoring Device.
Official Title  ICMJE Pilot Study to Assess the Difference in Glycemic Profiles Between Vildagliptin and Glimepiride Using Continuous Glucose Monitoring Device
Brief Summary This study will use Continuous Glucose Monitoring to assess differences in glycemic profiles between vildagliptin and glimepiride.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type II Diabetes Mellitus
Intervention  ICMJE
  • Drug: Vildagliptin
  • Drug: Glimepiride
Study Arms  ICMJE
  • Experimental: Vildagliptin
    Intervention: Drug: Vildagliptin
  • Active Comparator: Glimepiride
    Intervention: Drug: Glimepiride
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 16, 2010)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01262586
Other Study ID Numbers  ICMJE CLAF237A23151
2010-021236-34 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date November 2016

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