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Completed

NCT Number: NCT00575471

Placebo Controlled Dose-Response Study of Rivoglitazone in Type 2 Diabetes

The purpose of this study is to assess the efficacy response of rivoglitazone HCl on the change in HbA1c after 12 weeks of treatment in patients with type 2 diabetes.

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Key information

Conditions

Type 2 Diabetes Carotid Intimal Medial Thickness 1 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fukuoka, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • type 2 diabetes mellitus
  • HbA1c >6.5% and <10%
  • FPG >126 mg/dL (7mmol/L) and <270 mg/dL (15 mmol/L)

Exclusion criteria

  • history of type 1 diabetes
  • history of ketoacidosis
  • current insulin therapy
  • C-peptide <0.5ng/mL
  • impaired hepatic function
  • CHF or history of CHF (NYHA stage I - IV)
  • uncontrolled hypertension

Treatment and study plan

Rivoglitazone HCl

Drug

0.5 mg tablets once daily for 12 weeks

Placebo

Drug

Matching placebo tablets once daily for 12 weeks

Primary outcomes

  1. Change in HbA1c from baseline for rivoglitazone compared to placebo

    Time frame: 12 weeks

Secondary outcomes

  1. Change in Fasting Plasma Glucose from baseline for rivoglitazone HCl compared to placebo

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled 12-Week Dose-Response Study of Rivoglitazone (CS-011) in Patients With Type 2 Diabetes.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 18, 2007
Registry last updated
Mar 2, 2009

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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