Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well Controlled With Metformin Alone - Full Text View

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00396357

Purpose

This study is designed to evaluate the efficacy and safety of vildagliptin in combination with metformin 500 mg bid compared to metformin 1000 mg bid in patients with type 2 diabetes.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Vildagliptin Drug: metformin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Multicenter, Double-blind, Randomized Parallel-group, Study to Demonstrate the Effect of 24 Weeks Treatment With Vildagliptin 100 mg qd as add-on to Metformin 500 mg Bid Compared to Metformin 1000 mg Bid in Patients With Type 2 Diabetes Inadequately Controlled on Metformin 500 mg Bid Monotherapy

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: Vildagliptin Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in hemoglobin A 1 c (HbA1c) after 24 weeks of treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse event profile after 24 weeks of treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Gastrointestinal tolerability after 24 weeks of treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Patients with endpoint HbA1c <7% and <6.5% after 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Patients with reduction in HbA1c >0.7% after 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change from baseline in fasting plasma glucose after 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment:	914
Study Start Date:	October 2006
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: vildagliptin + metformin	Drug: Vildagliptin
Active Comparator: Metformin	Drug: metformin

Eligibility

Ages Eligible for Study:	18 Years to 78 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18-78 years inclusive
Type 2 diabetes diagnosis at least 2 months prior to study entry
Body mass index in the range of 22-45 kg/m2
HbA1c in the range of 6.5 to 9% inclusive
Fasting plasma glucose <270 mg/dL (15 mmol/L)

Exclusion Criteria:

A history of type 1 diabetes
Evidence of significant diabetic complications
Treatment with insulin or any other oral antidiabetic agents
Congestive heart failure requiring pharmacologic treatment
Clinically significant renal dysfunction defined by metformin labeling criteria (serum creatinine levels >/= 1.5 mg/dl (males) and >/= 1.4 mg/dl (females)

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396357

Locations

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

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00396357 History of Changes
Other Study ID Numbers:	CLAF237A23104
Study First Received:	November 2, 2006
Last Updated:	February 27, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Type 2 diabetes
vildagliptin
hemoglobin A1c
metformin

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Metformin

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012