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

June 7, 2007
February 1, 2010
April 2007
February 2009   (final data collection date for primary outcome measure)
Glycemic control - HbA1c [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Glycemic control - HbA1c [ Time Frame: 26 weeks ]
Complete list of historical versions of study NCT00484198 on ClinicalTrials.gov Archive Site
Glycemic control - FPG Responder rates - A1C Effects on lipid parameters [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Glycemic control - FPG Responder rates - A1C Effects on lipid parameters
Not Provided
Not Provided
 
Randomized, Double-Blind Active Comparator-Controlled Study of Rivoglitazone in Type 2 Diabetes Mellitus
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: pioglitazone
    Tablets
    Other Name: Actos
  • Drug: placebo
    Tablets
  • Drug: rivoglitazone HCl
    Tablets
  • Placebo Comparator: 1
    Intervention: Drug: placebo
  • Experimental: 2
    Rivoglitazone 1.0 mg
    Intervention: Drug: rivoglitazone HCl
  • Experimental: 3
    Rivoglitazone 1.5 mg
    Intervention: Drug: rivoglitazone HCl
  • Active Comparator: 4
    Pioglitazone 45 mg
    Intervention: Drug: pioglitazone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1820
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Austria,   Chile,   Czech Republic,   Germany,   Hungary,   India,   Latvia,   Mexico,   Peru,   Puerto Rico,   Romania,   Serbia,   Slovakia,   South Africa,   Ukraine,   United Kingdom
 
NCT00484198
CS0011-A-U301
Yes
Vice President, Clinical Development, Daiichi Sankyo
Daiichi Sankyo Inc.
Not Provided
Not Provided
Daiichi Sankyo Inc.
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP