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

Sponsored by:	Daiichi Sankyo Inc.
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00484198

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 III

MedlinePlus related topics: Diabetes

Drug Information available for: Pioglitazone Pioglitazone hydrochloride Rivoglitazone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: placebo Tablets
2: Experimental Rivoglitazone 1.0 mg	Drug: rivoglitazone HCl Tablets
3: Experimental Rivoglitazone 1.5 mg	Drug: rivoglitazone HCl Tablets
4: Active Comparator Pioglitazone 45 mg	Drug: pioglitazone Tablets

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484198

Show 184 Study Locations

Sponsors and Collaborators

Daiichi Sankyo Inc.

More Information

Responsible Party:	Daiichi Sankyo ( Vice President, Clinical Development )
Study ID Numbers:	CS0011-A-U301
Study First Received:	June 7, 2007
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00484198
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Pioglitazone
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009