Efficacy and Safety of Vildagliptin Compared to Acarbose in Drug Naive Patients With Type 2 Diabetes

This study has been completed.

First Received: May 4, 2005 Last Updated: January 2, 2007 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00110240

Purpose

This study is not being conducted in the United States. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to acarbose in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.

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

MedlinePlus related topics: Diabetes

Drug Information available for: Acarbose Vildagliptin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Vildagliptin Compared to Acarbose in Drug Naive Patients With Type 2 Diabetes

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in HbA1c at 24 weeks

Secondary Outcome Measures:

Change from baseline in HbA1c at 24 weeks for subset of Chinese patients
Overall adverse event profile after 24 weeks of treatment
Gastrointestinal side effect profiles after 24 weeks of treatment
Change from baseline in fasting plasma glucose at 24 weeks
Patients with endpoint HbA1c <7% after 24 weeks

Estimated Enrollment:	660
Study Start Date:	April 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Not currently on drug therapy for type 2 diabetes
Body mass index (BMI) in the range 20-40
Blood glucose criteria must be met

Exclusion Criteria:

Pregnancy or lactation
Type 1 diabetes
Evidence of significant diabetic complications
Evidence of serious cardiovascular conditions
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: NCT00110240

Locations

Switzerland
Novartis Pharmaceuticals
Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	CLAF237A2323
Study First Received:	May 4, 2005
Last Updated:	January 2, 2007
ClinicalTrials.gov Identifier:	NCT00110240 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Type 2 diabetes
vildagliptin

Study placed in the following topic categories:

Acarbose
Dipeptidyl-Peptidase IV Inhibitors
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Vildagliptin
Metabolic Disorder
Protease Inhibitors

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Enzyme Inhibitors
Glucose Metabolism Disorders
Vildagliptin
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on May 07, 2009