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Randomized, Double-Blind Active Comparator-Controlled Study of Rivoglitazone in Type 2 Diabetes Mellitus

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: NCT00484198
Recruitment Status : Completed
First Posted : June 8, 2007
Last Update Posted : February 3, 2010
Information provided by:
Daiichi Sankyo, Inc.

Brief Summary:
This is a 26-week, multicenter, randomized, double-blind, placebo and active comparator (Pioglitazone)-controlled, parallel-group study in subjects with type 2 diabetes currently sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic monotherapy. The total duration of a subject's participation will be approximately 30 weeks, including a 2-week placebo run-in period, a 26-week double-blind treatment period, and a 2-week post-treatment follow-up period.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: pioglitazone Drug: placebo Drug: rivoglitazone HCl Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1820 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo and Active Comparator-Controlled, Parallel-Group Study of the Efficacy and Safety of Rivoglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Study Start Date : April 2007
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: 1 Drug: placebo

Experimental: 2
Rivoglitazone 1.0 mg
Drug: rivoglitazone HCl

Experimental: 3
Rivoglitazone 1.5 mg
Drug: rivoglitazone HCl

Active Comparator: 4
Pioglitazone 45 mg
Drug: pioglitazone
Other Name: Actos

Primary Outcome Measures :
  1. Glycemic control - HbA1c [ Time Frame: 26 weeks ]

Secondary Outcome Measures :
  1. Glycemic control - FPG Responder rates - A1C Effects on lipid parameters [ Time Frame: 26 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of type 2 diabetes
  • Male or female at least 18 years of age
  • A1C > 7% and less or equal to 8.5%
  • Non-fasting C-peptide > 0.5ng/mL
  • Current monotherapy treatment with stable dose of approved non-TZD antihyperglycemic medication for greater or equal to 3 months prior to screening or
  • Untreated with any antihyperglycemic agent during 2 months prior to screening

Exclusion Criteria:

  • History of type 1 diabetes or ketoacidosis
  • History of long-term therapy with insulin
  • BMI > 45 kg/m2
  • Known history of CHF
  • Impaired hepatic function
  • History of prior treatment failure with, or intolerance of, a TZD
  • Contraindication to treatment with pioglitazone
  • Treatment with fibrates
  • If untreated with oral antihyperglycemic, considered to have failed diet and exercise modification as sole treatment for type 2 diabetes

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): NCT00484198

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Sponsors and Collaborators
Daiichi Sankyo, Inc.
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Responsible Party: Vice President, Clinical Development, Daiichi Sankyo Identifier: NCT00484198    
Other Study ID Numbers: CS0011-A-U301
First Posted: June 8, 2007    Key Record Dates
Last Update Posted: February 3, 2010
Last Verified: February 2010
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs