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

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00382096

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	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Vildagliptin Drug: Metformin Drug: Vildagliptin + Metformin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Vildagliptin Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in HbA1c [ Time Frame: At week 24 ] [ Designated as safety issue: No ]

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 ]

Enrollment:	1179
Study Start Date:	September 2006
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Vildagliptin + Metformin Dose 1: Experimental	Drug: Vildagliptin + Metformin
Vildagliptin + Metformin Dose 2: Experimental	Drug: Vildagliptin + Metformin
Vildagliptin: Active Comparator	Drug: Vildagliptin
Metformin: Active Comparator	Drug: Metformin

Eligibility

Ages Eligible for Study:	18 Years to 78 Years
Genders Eligible for Study:	Both

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00382096

Locations

United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Germany

Investigative Centers, Germany

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Additional Information:

Novartis patient recruitment website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CLMF237A2302
Study First Received:	September 26, 2006
Last Updated:	July 23, 2009
ClinicalTrials.gov Identifier:	NCT00382096 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; United States: Food and Drug Administration

Keywords provided by Novartis:

Type 2 diabetes
vildagliptin
metformin
hemoglobin A1c

Additional relevant MeSH terms:

Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Metformin
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors

Vildagliptin
Pharmacologic Actions
Protease Inhibitors
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010