Efficacy and Safety of Vildagliptin Compared to Gliclazide in Drug Naive Patients With Type 2 Diabetes

Novartis

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: vildagliptin; Drug: Gliclazide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00102388

CLAF237A2310

Details and patient eligibility

About

This study is not being conducted in the United States. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to gliclazide in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.

Enrollment: 1,092 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Not currently on drug therapy for type 2 diabetes
• Body mass index (BMI) in the range 22-45
• Blood glucose criteria must be met

Exclusion criteria

• Pregnancy or lactation
• Type 1 diabetes
• Evidence of significant diabetic complications
• Evidence of serious cardiovascular conditions
• Laboratory value abnormalities as defined by the protocol
• Other protocol-defined exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,092 participants in 2 patient groups

vildagliptin

Experimental group

Treatment:

Drug: vildagliptin

Gliclazide

Active Comparator group

Treatment:

Drug: Gliclazide