Placebo and Active Controlled Study of Rivoglitazone in Type 2 Diabetes

This study has been completed.

Sponsor:

Information provided by:

Daiichi Sankyo Inc.

ClinicalTrials.gov Identifier:

NCT00143520

First received: September 1, 2005

Last updated: April 8, 2011

Last verified: April 2011

History of Changes

Purpose

This is a 6-month study to evaluate the effects of monotherapy with rivoglitazone, an insulin sensitizer, on glycemic control in newly identified type 2 diabetics or diabetics not adequately treated with other antidiabetic agents. The study tests rivoglitazone and uses a placebo and active treatment group for comparison.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: Rivoglitazone Drug: Pioglitazone Drug: Placebo	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-blind, Double-dummy, Placebo-controlled 26-week Dose-response Study of Rivoglitazone HCl (CS-011) With Active Comparator (Pioglitazone HCl) in Subjects With Type 2 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Pioglitazone Pioglitazone hydrochloride

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

Change in HbA1c

Secondary Outcome Measures:

FPG, Lipids, hsCRP, Adiponectin

Enrollment:	441
Study Start Date:	December 2004
Study Completion Date:	December 2005
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetes in male or female patients
Between 18 and 75 years of age
With a HbA1c greater than or equal to 7.5% and less than 10.5% at randomization

Exclusion Criteria:

Type 1 diabetics or type 2 diabetics currently on insulin therapy
Patients unwilling or unable to discontinue their anti-diabetic medication(s)
History of ketoacidosis
History of therapy with rosiglitazone, troglitazone, pioglitazone

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143520

Show 74 Study Locations

Sponsors and Collaborators

Daiichi Sankyo Inc.

More Information

No publications provided by Daiichi Sankyo Inc.

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

Truitt KE, Goldberg RB, Rosenstock J, Chou HS, Merante D, Triscari J, Wang AC. A 26-week, placebo- and pioglitazone-controlled, dose-ranging study of rivoglitazone, a novel thiazolidinedione for the treatment of type 2 diabetes. Curr Med Res Opin. 2010 Jun;26(6):1321-31.

Responsible Party:	Medical monitor, Daiichi Sankyo
ClinicalTrials.gov Identifier:	NCT00143520 History of Changes
Other Study ID Numbers:	CS0011-203
Study First Received:	September 1, 2005
Last Updated:	April 8, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:

Placebo and active control dose response study of rivoglitazone in type 2 diabetics

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013

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