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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: vildagliptin; Drug: glimepiride; Drug: Metformin; Drug: Glimepiride matching placebo; Drug: Vildagliptin matching placebo

• Registration Number: NCT00106340
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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 long term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of glimepiride 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: 2005-03
• Study First Submitted: 2005-03-22
• Study First Submitted QC: 2005-03-22
• Study First Posted: 2005-03-23
• Primary Completion: 2008-05
• Study Completion: 2008-05-20
• Disposition First Submitted: 2012-10-22
• Disposition First Submitted QC: 2012-10-22
• Disposition First Posted: 2012-10-29
• Status Verified: 2012-12
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3118

Inclusion Criteria

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

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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
Vildagliptin	Glimepiride matching placebo	-
Glimepiride	Vildagliptin matching placebo	-
Vildagliptin	Metformin	-
Vildagliptin	vildagliptin	-
Glimepiride	glimepiride	-
Glimepiride	Metformin	-

Primary Outcome Measures

Name	Time	Method
Time to HbA1c >8%	2 year

Secondary Outcome Measures

Name	Time	Method
Change from baseline in body weight at 5 years	2 years (amended)
Adverse event profile after 5 years of treatment	2 years (amended)
Coefficient of failure for HbA1c from week 24 to 5 years	2 years (amended)
Change from baseline in fasting plasma glucose at 5 years	2 years (amended)
Change from baseline in HbA1c at 5 years	2 years (amended)

Trial Locations

Locations (2)

Investigative Centers; 🇩🇪 Nurnberg, Germany

Novartis Pharmaceuticals; 🇺🇸 East Hanover, New Jersey, United States