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

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ClinicalTrials.gov Identifier: NCT00484198
Recruitment Status : Completed
First Posted : June 8, 2007
Last Update Posted : February 3, 2010
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: pioglitazone Drug: placebo Drug: rivoglitazone HCl Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1820 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : April 2007
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Glycemic control - HbA1c [ Time Frame: 26 weeks ]

Secondary Outcome Measures :
  1. Glycemic control - FPG Responder rates - A1C Effects on lipid parameters [ Time Frame: 26 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00484198


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Sponsors and Collaborators
Daiichi Sankyo, Inc.

Responsible Party: Vice President, Clinical Development, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00484198     History of Changes
Other Study ID Numbers: CS0011-A-U301
First Posted: June 8, 2007    Key Record Dates
Last Update Posted: February 3, 2010
Last Verified: February 2010

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