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Vildagliptin Glycemic Profiles Assessment Using a Continuous Glucose Monitoring Device.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01262586
First received: December 16, 2010
Last updated: May 3, 2012
Last verified: May 2012
History of Changes
  Purpose

This study will use Continuous Glucose Monitoring to assess differences in glycemic profiles between vildagliptin and glimepiride.


Condition Intervention Phase
Type II Diabetes Mellitus
 Drug: Vildagliptin
Drug: Glimepiride
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study to Assess the Difference in Glycemic Profiles Between Vildagliptin and Glimepiride Using Continuous Glucose Monitoring Device

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in Glycemic profiles between vildagliptin and glimepiride [ Time Frame: Baseline and treatment Day 5, 24hr continuous glucose measurements ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glucose Fluctuation before and during treatment [ Time Frame: Baseline and treatment Day 5, 24hr continuous measurements ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: November 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vildagliptin Drug: Vildagliptin
Active Comparator: Glimepiride Drug: Glimepiride

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262586

Locations
Germany
Novartis Investigative Site
Mainz, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01262586     History of Changes
Other Study ID Numbers: CLAF237A23151, 2010-021236-34
Study First Received: December 16, 2010
Last Updated: May 3, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Type II Diabetes Mellitus
Vildagliptin
Glimepiride
Continuous glucose monitoring

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Vildagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013