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Placebo and Active Controlled Study of Rivoglitazone in Type 2 Diabetes

This study has been completed.
Information provided by:
Daiichi Sankyo, Inc. Identifier:
First received: September 1, 2005
Last updated: April 8, 2011
Last verified: April 2011
This is a 6-month study to evaluate the effects of monotherapy with rivoglitazone, an insulin sensitizer, on glycemic control in newly identified type 2 diabetics or diabetics not adequately treated with other antidiabetic agents. The study tests rivoglitazone and uses a placebo and active treatment group for comparison.

Condition Intervention Phase
Type 2 Diabetes Drug: Rivoglitazone Drug: Pioglitazone Drug: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Double-dummy, Placebo-controlled 26-week Dose-response Study of Rivoglitazone HCl (CS-011) With Active Comparator (Pioglitazone HCl) in Subjects With Type 2 Diabetes

Resource links provided by NLM:

Further study details as provided by Daiichi Sankyo, Inc.:

Primary Outcome Measures:
  • Change in HbA1c

Secondary Outcome Measures:
  • FPG, Lipids, hsCRP, Adiponectin

Enrollment: 441
Study Start Date: December 2004
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 2 diabetes in male or female patients
  • Between 18 and 75 years of age
  • With a HbA1c greater than or equal to 7.5% and less than 10.5% at randomization

Exclusion Criteria:

  • Type 1 diabetics or type 2 diabetics currently on insulin therapy
  • Patients unwilling or unable to discontinue their anti-diabetic medication(s)
  • History of ketoacidosis
  • History of therapy with rosiglitazone, troglitazone, pioglitazone
  Contacts and Locations
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Please refer to this study by its identifier: NCT00143520

  Show 74 Study Locations
Sponsors and Collaborators
Daiichi Sankyo, Inc.
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Medical monitor, Daiichi Sankyo Identifier: NCT00143520     History of Changes
Other Study ID Numbers: CS0011-203
Study First Received: September 1, 2005
Last Updated: April 8, 2011

Keywords provided by Daiichi Sankyo, Inc.:
Placebo and active control dose response study of rivoglitazone in type 2 diabetics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on September 21, 2017