Efficacy of Fixed Combination Therapy of Vildagliptin and Metformin Compared to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes | RxWiki

Efficacy of Fixed Combination Therapy of Vildagliptin and Metformin Compared to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes

Overview[ - collapse ][ - ]

Purpose	The purpose of this study is to evaluate the efficacy and safety of a fixed combination of vildagliptin and metformin in lowering blood glucose in patients with type 2 diabetes
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: Vildagliptin Drug: Metformin Drug: Vildagliptin + Metformin
Phase	Phase 3
Sponsor	Novartis Pharmaceuticals
Responsible Party	Novartis
ClinicalTrials.gov Identifier	NCT00382096
First Received	September 26, 2006
Last Updated	January 2, 2013
Last verified	January 2013

Tracking Information[ + expand ][ + ]

First Received Date	September 26, 2006
Last Updated Date	January 2, 2013
Start Date	September 2006
Estimated Primary Completion Date	Not Provided
Current Primary Outcome Measures	Change from baseline in HbA1c [Time Frame: At week 24] [Designated as safety issue: No]
Current Secondary Outcome Measures	Change from baseline in fasting plasma glucose [Time Frame: At week 24] [Designated as safety issue: No] Percent of patients with endpoint HbA1c <7% [Time Frame: At week 24] [Designated as safety issue: Yes] Percent of patients with reduction in HbA1c >/=0.7% [Time Frame: At week 24] [Designated as safety issue: No] Adverse event profile after treatment [Time Frame: At week 24] [Designated as safety issue: Yes] Change from baseline in body weight [Time Frame: At week 24] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Efficacy of Fixed Combination Therapy of Vildagliptin and Metformin Compared to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes
Official Title	A Randomized, Double-blind, Active-controlled, Multicenter Study to Compare the Effect of 24 Weeks Treatment With a Fixed Combination Therapy of Vildagliptin and Metformin to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes
Brief Summary	The purpose of this study is to evaluate the efficacy and safety of a fixed combination of vildagliptin and metformin in lowering blood glucose in patients with type 2 diabetes
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, Investigator), Primary Purpose: Treatment
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: Vildagliptin Drug: Metformin Drug: Vildagliptin + Metformin
Study Arm (s)	Experimental: Vildagliptin + Metformin Dose 1 Experimental: Vildagliptin + Metformin Dose 2 Active Comparator: Vildagliptin Active Comparator: Metformin

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	1179
Estimated Completion Date	Not Provided
Estimated Primary Completion Date	June 2008
Eligibility Criteria	Inclusion Criteria: - Male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes - Diagnosis of T2DM for at least 4 weeks prior to study entry - Age 18 - 78 years inclusive - Body mass index (BMI) of 22 - 40 kg/m2 - HbA1c: 7.5 - 11% inclusive - FPG <270 mg/dL (15 mmol/L) Exclusion Criteria - Pregnant or lactating female - A history of type 1 diabetes - Evidence of significant diabetic complications - Other protocol-defined inclusion/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	NCT00382096
Other Study ID Numbers	CLMF237A2302
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	January 2013

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