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 has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00728351

First received: July 31, 2008

Last updated: January 2, 2013

Last verified: January 2013

History of Changes

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment
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.

Resource links provided by NLM:

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:

HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy [ Time Frame: 24 weeks ]

Secondary Outcome Measures:

FPG reduction [ Time Frame: 24 weeks ]
Safety and tolerability [ Time Frame: 24 weeks ]
Body weight change from baseline [ Time Frame: 24 weeks ]
Changes in the fasting lipid profile [ Time Frame: 24 weeks ]


Enrollment:	317
Study Start Date:	June 2008
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: vildagliptin + metformin	Drug: vildagliptin + metformin
Active Comparator: metformin	Drug: metformin 1000 bid metformin

Eligibility


Ages Eligible for Study:	18 Years to 78 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Show 63 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators


Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

Additional Information:

Click here for more information on the clinical study This link exits the ClinicalTrials.gov site


Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00728351 History of Changes
Other Study ID Numbers:	CLMF237A2309
Study First Received:	July 31, 2008
Last Updated:	January 2, 2013

Keywords provided by Novartis ( Novartis Pharmaceuticals ):


Type 2 diabetes, vildagliptin

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 Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 22, 2017

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