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
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Rivoglitazone HCl
Drug: rivoglitazone HCl
Drug: placebo
Drug: pioglitazone HCl
Drug: pioglitazone HCl 45 mg
Drug: metformin
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:


Further study details as provided by Daiichi Sankyo Inc.:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 94
Study Start Date: November 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
rivoglitazone HCl 0.5mg
Drug: Rivoglitazone HCl
0.5 mg tablets
Other Name: CS-011
Drug: metformin
Oral tablets. Rescue medication.
Experimental: 2
rivoglitazone HCl 1.0 mg
Drug: rivoglitazone HCl
1.0 mg tablets
Other Name: CS-011
Drug: metformin
Oral tablets. Rescue medication.
Experimental: 3
rivolglitazone HCl 1.5 mg
Drug: rivoglitazone HCl
1.5 mg tablets
Other Name: CS-011
Drug: metformin
Oral tablets. Rescue medication.
Placebo Comparator: 4
placebo matching rivoglitazone HCl tablets
Drug: placebo
placebo tablets matching rivoglitazone tablets
Drug: metformin
Oral tablets. Rescue medication.
Active Comparator: 5
pioglitazone HCl 15 mg
Drug: pioglitazone HCl
15 mg tablets
Drug: metformin
Oral tablets. Rescue medication.
Active Comparator: 6
pioglitazone HCl 30 mg
Drug: pioglitazone HCl
30 mg tablets
Drug: metformin
Oral tablets. Rescue medication.
Active Comparator: 7
pioglitazone HCl 45 mg
Drug: pioglitazone HCl 45 mg
45 mg tablets
Drug: metformin
Oral tablets. Rescue medication.
Placebo Comparator: 8
matching placebo for pioglitazone
Drug: placebo
placebo capsules for pioglitazone
Drug: metformin
Oral tablets. Rescue medication.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571519

Locations
United States, Alabama
Huntsville, Alabama, United States, 35802
Huntsville, Alabama, United States, 35801
United States, California
San Diego, California, United States, 92128
San Francisco, California, United States, 94115
United States, Connecticut
Ridgefield, Connecticut, United States, 06877
United States, Florida
Fort Lauderdale, Florida, United States, 33308
Pembroke Pines, Florida, United States, 33026
United States, Mississippi
Port Gibson, Mississippi, United States, 39150
United States, Nevada
Las Vegas, Nevada, United States, 89119
United States, New Mexico
Albuquerque, New Mexico, United States, 87109
United States, Ohio
Kettering, Ohio, United States, 45429
United States, Pennsylvania
Fleetwood, Pennsylvania, United States, 19522
Harrisburg, Pennsylvania, United States, 17112
United States, South Carolina
Simpsonville, South Carolina, United States, 29681
United States, Texas
Daingerfield, Texas, United States, 75638
Dallas, Texas, United States, 75216
Plano, Texas, United States, 75093
San Antonio, Texas, United States, 78205
Sponsors and Collaborators
Daiichi Sankyo Inc.
Investigators
Study Director: VP Clinical Development, MD DSPD
  More Information

No publications provided

Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00571519     History of Changes
Other Study ID Numbers: CS011-A-U302
Study First Received: December 11, 2007
Last Updated: February 6, 2013
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
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014