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Clinical Trials/NCT01262586
NCT01262586CompletedPhase 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 enrollmentStarted: November 2010Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
24
Locations
1
Primary Endpoint
Change in Glycemic profiles between vildagliptin and glimepiride
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Glimepiride

Active Comparator

Intervention: Glimepiride (Drug)

Vildagliptin

Experimental

Intervention: Vildagliptin (Drug)

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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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