Randomized, Double-blind, Active-controlled, Study of Rivoglitazone in Type 2 Diabetes Mellitus

This study has been terminated.
(DSPD focussing on Study 301 to confirm clinical profile before proceeding.)
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00571519
First received: December 11, 2007
Last updated: February 6, 2013
Last verified: February 2013

December 11, 2007
February 6, 2013
November 2007
May 2008   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00571519 on ClinicalTrials.gov Archive Site
  • Fasting plasma glucose [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • HbA1c responder rates [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Effects on lipid parameters [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Randomized, Double-blind, Active-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-controlled, parallel-group study in subjects with type 2 diabetes currently sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic monotherapy. Pioglitazone is used as active comparator. The total duration of a subject's participation will be approximately 30 weeks, including a 2-week placebo lead-in period, a 26-week double-blind treatment period, and a 2-week post-treatment follow-up period. Subjects who complete the randomized portion of the study per protocol may have the opportunity to continue in a long-term extension study of active treatments.

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: Rivoglitazone HCl
    0.5 mg tablets
    Other Name: CS-011
  • Drug: rivoglitazone HCl
    1.0 mg tablets
    Other Name: CS-011
  • Drug: rivoglitazone HCl
    1.5 mg tablets
    Other Name: CS-011
  • Drug: placebo
    placebo tablets matching rivoglitazone tablets
  • Drug: pioglitazone HCl
    15 mg tablets
  • Drug: pioglitazone HCl
    30 mg tablets
  • Drug: pioglitazone HCl 45 mg
    45 mg tablets
  • Drug: placebo
    placebo capsules for pioglitazone
  • Drug: metformin
    Oral tablets. Rescue medication.
  • Experimental: 1
    rivoglitazone HCl 0.5mg
    Interventions:
    • Drug: Rivoglitazone HCl
    • Drug: metformin
  • Experimental: 2
    rivoglitazone HCl 1.0 mg
    Interventions:
    • Drug: rivoglitazone HCl
    • Drug: metformin
  • Experimental: 3
    rivolglitazone HCl 1.5 mg
    Interventions:
    • Drug: rivoglitazone HCl
    • Drug: metformin
  • Placebo Comparator: 4
    placebo matching rivoglitazone HCl tablets
    Interventions:
    • Drug: placebo
    • Drug: metformin
  • Active Comparator: 5
    pioglitazone HCl 15 mg
    Interventions:
    • Drug: pioglitazone HCl
    • Drug: metformin
  • Active Comparator: 6
    pioglitazone HCl 30 mg
    Interventions:
    • Drug: pioglitazone HCl
    • Drug: metformin
  • Active Comparator: 7
    pioglitazone HCl 45 mg
    Interventions:
    • Drug: pioglitazone HCl 45 mg
    • Drug: metformin
  • Placebo Comparator: 8
    matching placebo for pioglitazone
    Interventions:
    • Drug: placebo
    • Drug: metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
94
May 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • type 2 diabetes
  • HbA1c >7% and Less than or equal to 8.5%
  • C-peptide >0.5 ng/mL
  • current monotherapy with stable dose, non-thiazoleidine for greater than or equal to 3 months prior to screening
  • untreated with any antihyperglycemic agent during 2 months prior to screening

Exclusion Criteria:

  • type 1 diabetes
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00571519
CS011-A-U302
Yes
Daiichi Sankyo Inc.
Daiichi Sankyo Inc.
Not Provided
Study Director: VP Clinical Development, MD DSPD
Daiichi Sankyo Inc.
February 2013

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