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Clinical Trials/NCT01262586
NCT01262586
Completed
Phase 3

Pilot Study to Assess the Difference in Glycemic Profiles Between Vildagliptin and Glimepiride Using Continuous Glucose Monitoring Device

Novartis Pharmaceuticals1 site in 1 country24 target enrollmentNovember 2010
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ConditionsType II Diabetes Mellitus
InterventionsVildagliptinGlimepiride
DrugsVildagliptinGlimepiride

Overview

Phase
Phase 3
Intervention
Vildagliptin
Conditions
Type II Diabetes Mellitus
Sponsor
Novartis Pharmaceuticals
Enrollment
24
Locations
1
Primary Endpoint
Change in Glycemic profiles between vildagliptin and glimepiride
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
March 2011
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Arms & Interventions

Vildagliptin

Intervention: Vildagliptin

Glimepiride

Intervention: Glimepiride

Outcomes

Primary Outcomes

Change in Glycemic profiles between vildagliptin and glimepiride

Time Frame: Baseline and treatment Day 5, 24hr continuous glucose measurements

Secondary Outcomes

  • Glucose Fluctuation before and during treatment(Baseline and treatment Day 5, 24hr continuous measurements)

Study Sites (1)

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