Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis

ClinicalTrials.gov Identifier:

NCT00138619

First received: August 27, 2005

Last updated: May 4, 2012

Last verified: May 2012

History of Changes

Purpose

This is an 80-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to rosiglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: vildagliptin	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes

Resource links provided by NLM:

Drug Information available for: Rosiglitazone

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Safety during 104 weeks of treatment
Change from baseline in HbA1c at 104 weeks

Secondary Outcome Measures:

Change in HbA1c between 24 weeks and 104 weeks
Change from baseline in fasting plasma glucose at 104 weeks
Change in fasting plasma glucose between 24 weeks and 104 weeks
Change from baseline in HOMA B at 104 weeks
Change in HOMA B between 24 weeks and 104 weeks


Enrollment:	478
Study Start Date:	November 2004
Study Completion Date:	April 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All

Criteria

Inclusion Criteria:

Only patients successfully completing study CLAF237A2327 are eligible
Written informed consent
Ability to comply with all study requirements

Exclusion Criteria:

Premature discontinuation from study CLAF237A2327
Other protocol-defined 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: NCT00138619

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	Novartis Pharmaceuticals

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rosenstock J, Niggli M, Maldonado-Lutomirsky M. Long-term 2-year safety and efficacy of vildagliptin compared with rosiglitazone in drug-naïve patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2009 Jun;11(6):571-8. doi: 10.1111/j.1463-1326.2008.01021.x. Epub 2009 Apr 5.


Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00138619 History of Changes
Other Study ID Numbers:	CLAF237A2327E1
Study First Received:	August 27, 2005
Last Updated:	May 4, 2012

Keywords provided by Novartis:


Type 2 diabetes vildagliptin

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Vildagliptin Rosiglitazone	Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Hypoglycemic Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 26, 2017

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