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
  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:


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
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: NCT00484198

  Hide Study Locations
Locations
United States, Alabama
Anniston, Alabama, United States
Birmingham, Alabama, United States
Hoover, Alabama, United States
Muscle Shoals, Alabama, United States
United States, Arkansas
Hot Springs, Arkansas, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
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Buena Park, California, United States
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Springfield, Massachusetts, United States
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Portage, Michigan, United States
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Chile
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Germany
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Hungary
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Szentes, Hungary
India
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Maharashtra, India
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Riga, Latvia
Mexico
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Monterrey, Nuevo Leon, Mexico
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Merida, Yucatan, Mexico
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Peru
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Sunbury, Middlesex, United Kingdom
Addlestone, Surrey, United Kingdom
Wakefield, West Yorks, United Kingdom
Swindon, Wiltshire, United Kingdom
Chippenham, United Kingdom
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Pioglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014