A 56-Week Extension to a Clinical Study to Assess the Efficacy and Safety of Vildagliptin Compared to Placebo in Drug Naive Patients With Type 2 Diabetes and Mild Hyperglycemia - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00300287

Purpose

This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to gather data on the long-term safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo 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 and whose blood glucose levels are close to normal.

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

MedlinePlus related topics: Diabetes

Drug Information available for: Vildagliptin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 56-Week Extension to a Clinical Study to Assess the Efficacy and Safety of Vildagliptin Compared to Placebo in Drug Naive Patients With Type 2 Diabetes and Mild Hyperglycemia

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in HbA1c at 108 weeks

Secondary Outcome Measures:

Adverse event profile after 108 weeks of treatment
Change in HbA1c from week 52 to week 108
Change from baseline in fasting plasma glucose at week 108
Change in fasting plasma glucose from week 52 to week 108
Change from baseline in body weight at week 108

Estimated Enrollment:	150
Study Start Date:	February 2006

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Completion of study CLAF237A2307 within 4 weeks of entering into the extension
Written informed consent
Ability to comply with all study requirements
Blood glucose criteria must be met

Exclusion Criteria:

Premature discontinuation from study CLAF237A2307

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300287

Locations

Germany

Investigative Sites, Germany

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Publications indexed to this study:

Scherbaum WA, Schweizer A, Mari A, Nilsson PM, Lalanne G, Wang Y, Dunning BE, Foley JE. Evidence that vildagliptin attenuates deterioration of glycaemic control during 2-year treatment of patients with type 2 diabetes and mild hyperglycaemia. Diabetes Obes Metab. 2008 Nov;10(11):1114-24. Epub 2008 Mar 18.

Study ID Numbers:	CLAF237A2307E1
Study First Received:	March 6, 2006
Last Updated:	July 16, 2007
ClinicalTrials.gov Identifier:	NCT00300287
Health Authority:	Finland: National Agency for Medicines

Keywords provided by Novartis:

Type 2 diabetes
Vildagliptin

Study placed in the following topic categories:

Metabolic Diseases
Hyperglycemia
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 15, 2009