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OpenTrials
Completed

NCT Number: NCT00143520

Placebo and Active Controlled Study of Rivoglitazone in Type 2 Diabetes

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivoglitazone

Drug

pioglitazone

Drug

Placebo

Drug

Primary outcomes

  1. Change in HbA1c

Secondary outcomes

  1. FPG, Lipids, hsCRP, Adiponectin

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 2, 2005
Registry last updated
May 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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