Vildagliptin Glycemic Profiles Assessment Using a Continuous Glucose Monitoring Device.

Phase 3

Completed

• Conditions: Type II Diabetes Mellitus
• Interventions: Drug: Glimepiride; Drug: Vildagliptin

• Registration Number: NCT01262586
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-12-16
• Study First Submitted QC: 2010-12-16
• Study First Posted: 2010-12-17
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Glimepiride	Glimepiride	-
Vildagliptin	Vildagliptin	-

Primary Outcome Measures

Name	Time	Method
Change in Glycemic profiles between vildagliptin and glimepiride	Baseline and treatment Day 5, 24hr continuous glucose measurements

Secondary Outcome Measures

Name	Time	Method
Glucose Fluctuation before and during treatment	Baseline and treatment Day 5, 24hr continuous measurements

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Mainz, Germany