Efficacy and Safety of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes and Mild Hyperglycemia

Novartis

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Vildagliptin Placebo; Drug: vildagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00101712

CLAF237A2307

Details and patient eligibility

About

This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo 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 and whose blood glucose levels are close to normal.

Enrollment: 274 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Blood glucose criteria must be met
• Not currently on drug therapy for type 2 diabetes
• Body mass index (BMI) in the range 22-45
• Diagnosis of type 2 diabetes for at least 8 weeks

Exclusion criteria

• Pregnancy or lactation
• Type 1 diabetes
• Evidence of serious diabetic complications
• Evidence of serious cardiovascular complications
• Significant laboratory 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: Double Blind

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274 participants in 2 patient groups, including a placebo group

Vildagliptin

Experimental group

Treatment:

Drug: vildagliptin

Placebo

Placebo Comparator group

Treatment:

Drug: Vildagliptin Placebo