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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: vildagliptin Drug: glimepiride Drug: Metformin Drug: Vildagliptin matching placebo Drug: Glimepiride matching placebo
Phase	Phase 3
Sponsor	Novartis Pharmaceuticals
Responsible Party	Novartis
ClinicalTrials.gov Identifier	NCT00106340
First Received	March 22, 2005
Last Updated	December 28, 2012
Last verified	December 2012

Tracking Information[ + expand ][ + ]

First Received Date	March 22, 2005
Last Updated Date	December 28, 2012
Start Date	March 2005
Estimated Primary Completion Date	Not Provided
Current Primary Outcome Measures	Time to HbA1c >8% [Time Frame: 2 year] [Designated as safety issue: No]
Current Secondary Outcome Measures	Change from baseline in HbA1c at 5 years [Time Frame: 2 years (amended)] [Designated as safety issue: No] Adverse event profile after 5 years of treatment [Time Frame: 2 years (amended)] [Designated as safety issue: Yes] Coefficient of failure for HbA1c from week 24 to 5 years [Time Frame: 2 years (amended)] [Designated as safety issue: No] Change from baseline in fasting plasma glucose at 5 years [Time Frame: 2 years (amended)] [Designated as safety issue: No] Change from baseline in body weight at 5 years [Time Frame: 2 years (amended)] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Vildagliptin Compared to Glimepiride in Combination With Metformin in Patients With Type 2 Diabetes
Official Title	Vildagliptin Compared to Glimepiride in Combination With Metformin in Patients With Type 2 Diabetes
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 Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: vildagliptin Other Names: LAF237, GalvusDrug: glimepiride Drug: Metformin Drug: Vildagliptin matching placebo Drug: Glimepiride matching placebo
Study Arm (s)	Experimental: Vildagliptin Active Comparator: Glimepiride

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	3118
Estimated Completion Date	Not Provided
Estimated Primary Completion Date	May 2008
Eligibility Criteria	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 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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States, Germany

Administrative Information[ + expand ][ + ]

NCT Number	NCT00106340
Other Study ID Numbers	CLAF237A2308
Has Data Monitoring Committee	Not Provided
Information Provided By	Novartis
Study Sponsor	Novartis Pharmaceuticals
Collaborators	Not Provided
Investigators	Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Verification Date	December 2012

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