Placebo and Active Controlled Study of Rivoglitazone in Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00143520
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : April 11, 2011
Information provided by:
Daiichi Sankyo, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Rivoglitazone Drug: Pioglitazone Drug: Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 441 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2004
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Change in HbA1c

Secondary Outcome Measures :
  1. FPG, Lipids, hsCRP, Adiponectin

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00143520

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Sponsors and Collaborators
Daiichi Sankyo, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Medical monitor, Daiichi Sankyo Identifier: NCT00143520     History of Changes
Other Study ID Numbers: CS0011-203
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: April 11, 2011
Last Verified: April 2011

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
Hypoglycemic Agents
Physiological Effects of Drugs