NCT00575471

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_2 type-2-diabetes

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_2 type-2-diabetes

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

March 2, 2009

Status Verified

February 1, 2009

Enrollment Period

8 months

First QC Date

December 17, 2007

Last Update Submit

February 27, 2009

Conditions

Type 2 Diabetes

Keywords

rivoglitazone HClthiazolidinedioneperoxisome proliferator-activated receptor gamma (PPARgamma)diabetes mellitus, type 2

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c from baseline for rivoglitazone compared to placebo

    12 weeks

Secondary Outcomes (1)

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

    12 weeks

Study Arms (4)

1

EXPERIMENTAL

rivoglitazone HCl 0.5 mg tablets once daily for 12 weeks

Drug: Rivoglitazone HCl

2

EXPERIMENTAL

rivoglitazone HCl 1 mg tablets once daily for 12 weeks

Drug: rivoglitazone HCl

3

EXPERIMENTAL

rivoglitazone HCl 1.5 mg tablets once daily for 12 weeks

Drug: rivoglitazone HCl

4

PLACEBO COMPARATOR

Matching placebo tablets once daily for 12 weeks

Drug: Placebo

Interventions

rivoglitazone HClDRUG

0.5 mg tablets once daily for 12 weeks

1
PlaceboDRUG

Matching placebo tablets once daily for 12 weeks

4

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Carotid Intimal Medial Thickness 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 17, 2007

First Posted

December 18, 2007

Study Start

July 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

March 2, 2009

Record last verified: 2009-02

Locations

JP(3)