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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Vildagliptin Placebo; Drug: vildagliptin

• Registration Number: NCT00101712
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-01-12
• Study First Submitted QC: 2005-01-12
• Study First Posted: 2005-01-13
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-04
• Last Update Posted: 2012-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 274

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Vildagliptin Placebo	-
Vildagliptin	vildagliptin	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in HbA1c at 52 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in fasting plasma glucose at 52 weeks
Coefficient of failure for HbA1c between 24 weeks and 52 weeks
Adverse event profile after 52 weeks of treatment
Patients with HbA1c <6.5% at 12 weeks
Patients with HbA1c <6.5% at 52 weeks

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇭 Basel, Switzerland