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

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00484198
First received: June 7, 2007
Last updated: February 1, 2010
Last verified: February 2010
History of Changes
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
 Drug: pioglitazone
Drug: placebo
Drug: rivoglitazone HCl
 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, Placebo and Active Comparator-Controlled, Parallel-Group Study of the Efficacy and Safety of Rivoglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Glycemic control - HbA1c [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glycemic control - FPG Responder rates - A1C Effects on lipid parameters [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1820
Study Start Date: April 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: placebo
Tablets
Experimental: 2
Rivoglitazone 1.0 mg
 Drug: rivoglitazone HCl
Tablets
Experimental: 3
Rivoglitazone 1.5 mg
 Drug: rivoglitazone HCl
Tablets
Active Comparator: 4
Pioglitazone 45 mg
 Drug: pioglitazone
Tablets
Other Name: Actos

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00484198

  Show 184 Study Locations
Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

No publications provided

Responsible Party: Vice President, Clinical Development, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00484198     History of Changes
Other Study ID Numbers: CS0011-A-U301
Study First Received: June 7, 2007
Last Updated: February 1, 2010
Health Authority: United States: Food and Drug Administration

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 May 22, 2013