Efficacy of Vildagliptin 100 MG as Compared to Placebo as Add-on to Metformin in Patients With Type 2 Diabetes - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00351884

Purpose

Vildagliptin is an oral anti-diabetic agent. This is a 24-week study to assess the efficacy on HbA1c of 100 mg vildagliptin once daily as compared to placebo as add-on to metformin in patients with type 2 diabetes inadequately controllled with metformin.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Vildagliptin	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, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 24 Weeks Treatment With Vildagliptin 100 MG QD to Placebo as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in HbA1c at 24 weeks

Secondary Outcome Measures:

Safety of vildagliptin in combination with metformin during 24 weeks of treatment
Change from baseline in fasting plasma glucose at 24 weeks
Patients with endpoint HbA1c < 7% after 24 weeks
Patients with reduction in HbA1c greater than or equal to 0.7% after 24 weeks
Change from baseline in body weight at 24 weeks

Estimated Enrollment:	369
Study Start Date:	May 2006

Eligibility

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

Criteria

Inclusion Criteria:

Patients on metformin for at least three months and on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1
Body mass index in the range 22-40
Blood glucose criteria must be met

Exclusion Criteria:

Pregnancy or lactation
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: NCT00351884

Locations

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

Investigative Centers, Germany

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

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

Study ID Numbers:	CLAF237A23103
Study First Received:	July 11, 2006
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00351884
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Type 2 diabetes
vildagliptin
Hemoglobin A1c

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
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009