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Sponsored by: |
Daiichi Sankyo Inc. |
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Information provided by: | Daiichi Sankyo Inc. |
ClinicalTrials.gov Identifier: | NCT00484198 |
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 |
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 |
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
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Metabolic Diseases Pioglitazone Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |