Vildagliptin Glycemic Profiles Assessment Using a Continuous Glucose Monitoring Device.

Novartis

Status and phase: Completed; Phase 3

Conditions: Type II Diabetes Mellitus

Treatments: Drug: Vildagliptin; Drug: Glimepiride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01262586

2010-021236-34 (EudraCT Number)

CLAF237A23151

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Vildagliptin

Experimental group

Treatment:

Drug: Vildagliptin

Glimepiride

Active Comparator group

Treatment:

Drug: Glimepiride