Randomized, Double-Blind, Active-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:	NCT00571519

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 III

MedlinePlus related topics: Diabetes

Drug Information available for: Pioglitazone Pioglitazone hydrochloride Metformin Metformin hydrochloride Rivoglitazone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), 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:

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
1: Experimental rivoglitazone HCl 0.5mg	Drug: Rivoglitazone HCl o.5 mg tablets Drug: metformin Oral tablets. Rescue medication.
2: Experimental rivoglitazone HCl 1.0 mg	Drug: rivoglitazone HCl 1.0 mg tablets Drug: metformin Oral tablets. Rescue medication.
3: Experimental rivolglitazone HCl 1.5 mg	Drug: rivoglitazone HCl 1.5 mg tablets Drug: metformin Oral tablets. Rescue medication.
4: Placebo Comparator placebo matching rivoglitazone HCl tablets	Drug: placebo placebo tablets matching rivoglitazone tablets Drug: metformin Oral tablets. Rescue medication.
5: Active Comparator pioglitazone HCl 15 mg	Drug: pioglitazone HCl 15 mg tablets Drug: metformin Oral tablets. Rescue medication.
6: Active Comparator pioglitazone HCl 30 mg	Drug: pioglitazone HCl 30 mg tablets Drug: metformin Oral tablets. Rescue medication.
7: Active Comparator pioglitazone HCl 45 mg	Drug: pioglitazone HCl 45 mg 45 mg tablets Drug: metformin Oral tablets. Rescue medication.
8: Placebo Comparator 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

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 Francisco, California, United States, 94115

San Diego, California, United States, 92128
United States, Connecticut

Ridgefield, Connecticut, United States, 06877
United States, Florida

Pembroke Pines, Florida, United States, 33026

Fort Lauderdale, Florida, United States, 33308
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

Harrisburg, Pennsylvania, United States, 17112

Fleetwood, Pennsylvania, United States, 19522
United States, South Carolina

Simpsonville, South Carolina, United States, 29681
United States, Texas

Dallas, Texas, United States, 75216

Plano, Texas, United States, 75093

Daingerfield, Texas, United States, 75638

San Antonio, Texas, United States, 78205

Sponsors and Collaborators

Daiichi Sankyo Inc.

Investigators

Study Director:

VP Clinical Development, MD

DSPD

More Information

Responsible Party:	Daiichi Sankyo, Inc. ( Executive Director, Clinical development )
Study ID Numbers:	CS011-A-U302
Study First Received:	December 11, 2007
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00571519
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Pioglitazone
Metformin
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 13, 2009