NCT00057304

Brief Summary

The objective of the study is to determine the dose(s) of Ro 205-2349 which, when compared to placebo, are efficacious, safe and tolerable in improving glycemic control in patients with type 2 diabetes. Doses of 2 to 5 mg/day will be studied.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
190

participants targeted

Target at P75+ for phase_2 diabetes

Timeline
Completed

Started Jun 2003

Shorter than P25 for phase_2 diabetes

Geographic Reach
9 countries

46 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

First Submitted

Initial submission to the registry

March 31, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 1, 2003

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2003

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

9 months

First QC Date

March 31, 2003

Last Update Submit

April 27, 2023

Conditions

Diabetes

Study Arms (2)

RO 205-2349 2 mg QD

EXPERIMENTAL

RO 205-2349 2 mg was taken once daily (QD) for 16 weeks during the double-blind treatment period.

Drug: RO 205-2349

RO 205-2349 5 mg QD

EXPERIMENTAL

RO 205-2349 5 mg was taken once daily (QD) for 16 weeks during the double-blind treatment period.

Drug: RO 205-2349

Interventions

RO 205-2349DRUG
Also known as: Edaglitazone
RO 205-2349 2 mg QDRO 205-2349 5 mg QD

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 35 to 75
  • Type 2 diabetes for longer than 3 months
  • HbA1c (glycosylated hemoglobin A1c) greater than 7.0% at screening
  • FPG (fasting plasma glucose) greater than 126 mg/dL at screening
  • BMI (body mass index) less than 40 kg/square meter

You may not qualify if:

  • Type I diabetes
  • Type 2 diabetes patients currently treated with insulin
  • Type 2 diabetes patients currently or previously treated with Actos, Avandia or Rezulin
  • FPG (fasting plasma glucose) greater than 270 mg/dL at baseline
  • Impaired liver or kidney function
  • Triglycerides greater than 600 mg/dL
  • Uncontrolled hypertension
  • Pregnant or lactating women
  • Women not using adequate contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (46)

Unknown Facility

Hollywood, Florida, 33021, United States

Location

Unknown Facility

Durham, North Carolina, 27710, United States

Location

Unknown Facility

Morrisville, North Carolina, 27560, United States

Location

Unknown Facility

Portland, Oregon, 97219, United States

Location

Unknown Facility

Portland, Oregon, 97239, United States

Location

Unknown Facility

Camp Hill, Pennsylvania, 17011, United States

Location

Unknown Facility

Greer, South Carolina, 29651, United States

Location

Unknown Facility

Memphis, Tennessee, 38119, United States

Location

Unknown Facility

Memphis, Tennessee, 38163, United States

Location

Unknown Facility

Dallas, Texas, 75230, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Midland, Texas, 79705, United States

Location

Unknown Facility

Lebanon, Virginia, 24266, United States

Location

Unknown Facility

Virginia Beach, Virginia, 23451, United States

Location

Unknown Facility

Pleven, 5800, Bulgaria

Location

Unknown Facility

Plovdiv, 4002, Bulgaria

Location

Unknown Facility

Sofia, 1233, Bulgaria

Location

Unknown Facility

Sofia, 1431, Bulgaria

Location

Unknown Facility

Sofia, 1606, Bulgaria

Location

Unknown Facility

Tallinn, 10138, Estonia

Location

Unknown Facility

Tartu, 50406, Estonia

Location

Unknown Facility

Tartu, 50708, Estonia

Location

Unknown Facility

Võru, 65609, Estonia

Location

Unknown Facility

Chihuahua, Chih., Mexico

Location

Unknown Facility

Guadalajara, 44349, Mexico

Location

Unknown Facility

Guadalajara, JAL., 44340, Mexico

Location

Unknown Facility

Mexico City, 06700, Mexico

Location

Unknown Facility

Mérida, 97000, Mexico

Location

Unknown Facility

Monterrey, 64320, Mexico

Location

Unknown Facility

Monterrey, 64410, Mexico

Location

Unknown Facility

Monterrey, 64460, Mexico

Location

Unknown Facility

Pachuca, Hidalgo, 42039, Mexico

Location

Unknown Facility

Panama City, Panama

Location

Unknown Facility

Ponce, 00732-7994, Puerto Rico

Location

Unknown Facility

Arad, 2900, Romania

Location

Unknown Facility

Brasov, 500326, Romania

Location

Unknown Facility

Bucharest, 020475, Romania

Location

Unknown Facility

Bucharest, 7000, Romania

Location

Unknown Facility

Craiova, 1100, Romania

Location

Unknown Facility

Galati, 6200, Romania

Location

Unknown Facility

Ploieşti, 2000, Romania

Location

Unknown Facility

Târgovişte, 0200, Romania

Location

Unknown Facility

Târgu Mureş, 4300, Romania

Location

Unknown Facility

Meyrin, 1217, Switzerland

Location

Unknown Facility

Bracknell, RG12 1HX, United Kingdom

Location

Unknown Facility

Nottingham, NG2 3HF, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

BM 13.1258

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: All potential participants entered the placebo run-in phase. At the end of the placebo run-in phase, eligible participants who met the final inclusion/exclusion criteria were randomized to the double-blind treatment period. treatment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2003

First Posted

April 1, 2003

Study Start

June 1, 2003

Primary Completion

March 1, 2004

Study Completion

March 1, 2004

Last Updated

April 28, 2023

Record last verified: 2023-04

Locations

ME(9)BU(5)US(14)GB(2)ES(4)PA(1)PR(1)RO(9)CH(1)