A Clinical Study to Assess the Effect of Vildagliptin on Beta Cell Function in Drug Naive Patients With Type 2 Diabetes

Novartis

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: placebo; Drug: vildagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00260156

CLAF237A2381

Details and patient eligibility

About

This study is not being conducted in the United States. The purpose of this study is to assess the effect of vildagliptin, an unapproved drug, on various measures of pancreatic islet function in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.

Enrollment: 59 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Not currently on drug therapy for type 2 diabetes
• Blood glucose criteria must be met

Exclusion criteria

• History of type 1 diabetes
• Evidence of significant diabetic complications
• Serious cardiovascular events within the past 6 months
• Other protocol-defined exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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59 participants in 2 patient groups, including a placebo group

vildagliptin

Experimental group

Treatment:

Drug: vildagliptin

Placebo

Placebo Comparator group

Treatment:

Drug: placebo