Efficacy and Safety of Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy (HbA1c 7.0-9.5%)

This study is currently recruiting participants.

Verified by Novartis, August 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00728351

Purpose

The present study is designed to evaluate the efficacy and safety of fixed combination therapy of vildagliptin and metformin (25/1000 mg bid) in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy.

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

MedlinePlus related topics: Diabetes

Drug Information available for: Metformin Metformin hydrochloride Vildagliptin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Double-Blind, Randomized Study to Compare the Efficacy of 24 Weeks Treatment With Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) Versus Metformin Monotherapy (1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy.

Further study details as provided by Novartis:

Primary Outcome Measures:

HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy

Secondary Outcome Measures:

FPG reduction
Safety and tolerability
Body weight change from baseline
Changes in the fasting lipid profile

Estimated Enrollment:	300
Study Start Date:	June 2008
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Active Comparator 1000 bid metformin	Drug: metformin 1000 bid metformin
1: Experimental vildagliptin metformin fixed dose combination 25/1000 mg bid	Drug: vildagliptin, metformin vildagliptin, metformin fixed dose combination 25/1000 mg bid

Eligibility

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

Criteria

Inclusion Criteria:

History of T2DM treated with Metformin

Exclusion Criteria:

FPG >= 260 mg/dL (14.4mmol/L)

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728351

Contacts

Contact: Customer Information Center	862-778-8300 (US)
Contact: Customer Information Center (EU)	41 61 324 1111

Show 48 Study Locations

Sponsors and Collaborators

Novartis

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CLMF237A2309
Study First Received:	July 31, 2008
Last Updated:	August 4, 2008
ClinicalTrials.gov Identifier:	NCT00728351
Health Authority:	France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; United States: Food and Drug Administration

Keywords provided by Novartis:

Type 2 diabetes, vildagliptin

Study placed in the following topic categories:

Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Vildagliptin

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 13, 2009