Vildagliptin Compared to Glimepiride in Combination With Metformin in Patients With Type 2 Diabetes - Full Text View

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00106340

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	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: vildagliptin Drug: glimepiride	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Vildagliptin Compared to Glimepiride in Combination With Metformin in Patients With Type 2 Diabetes

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Glimepiride Vildagliptin Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Time to HbA1c >8% [ Time Frame: 2 year ] [ Designated as safety issue: No ]

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 ]

Enrollment:	3118
Study Start Date:	March 2005
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Vildagliptin	Drug: vildagliptin
Active Comparator: Glimepiride	Drug: glimepiride

Eligibility

Ages Eligible for Study:	18 Years to 73 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106340

Locations

United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Germany
Investigative Centers
Nurnberg, Germany

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:	NCT00106340 History of Changes
Other Study ID Numbers:	CLAF237A2308
Study First Received:	March 22, 2005
Last Updated:	February 27, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

type 2 diabetes
vildagliptin

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Vildagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs

Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012