Vildagliptin Compared to Gliclazide in Combination With Metformin in Patients With Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Gliclazide; Drug: vildagliptin; Drug: Metformin

• Registration Number: NCT00102466
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study is not being conducted in the United States. Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to that of gliclazide in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted QC: 2005-01-28
• Study First Submitted: 2005-01-29
• Study First Posted: 2005-01-31
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Disposition First Submitted: 2013-01-02
• Disposition First Submitted QC: 2013-01-02
• Disposition First Posted: 2013-01-04
• Status Verified: 2017-05
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1007

Inclusion Criteria

• On a stable dose of metformin as defined by the protocol
• Blood glucose criteria must be met
• Body mass index (BMI) in the range 22-45

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gliclazide	Gliclazide	-
Vildagliptin	Metformin	-
Vildagliptin	vildagliptin	-
Gliclazide	Metformin	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in HbA1c at 52 weeks	52 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse event profile after 52 weeks of treatment	52 weeks
Change from baseline in fasting plasma glucose at 52 weeks	52 weeks
Patients with endpoint HbA1c <7% at 52 weeks	52 weeks
Patients with reduction in HbA1c >/= 0.7% after 52 weeks	52 weeks
Patients with reduction in HbA1c >/= 0.5% after 52 weeks	52 weeks

Trial Locations

Locations (2)

Investigative Centers; 🇩🇪 Nurnberg, Germany

Novartis Pharmaceuticals; 🇨🇭 Basel, Switzerland