Study to Determine the Efficacy, Safety, Tolerability & Pharmacokinetics of RO 205-2349 in Patients With Type 2 Diabetes Mellitus

April 27, 2023 updated by: Hoffmann-La Roche

A Phase II Randomized, Double-Blind, Dose-Ranging Study to Determine the Efficacy, Safety, Tolerability & Pharmacokinetics of RO 205-2349 in Patients With Type 2 Diabetes Mellitus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

190

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Pleven, Bulgaria, 5800
      • Plovdiv, Bulgaria, 4002
      • Sofia, Bulgaria, 1233
      • Sofia, Bulgaria, 1431
      • Sofia, Bulgaria, 1606
  • Estonia
      • Tallinn, Estonia, 10138
      • Tartu, Estonia, 50406
      • Tartu, Estonia, 50708
      • Voru, Estonia, 65609
  • Mexico
      • Chihuahua, Chih., Mexico
      • Guadalajara, Mexico, 44349
      • Guadalajara, JAL., Mexico, 44340
      • Merida, Mexico, 97000
      • Mexico City, Mexico, 06700
      • Monterrey, Mexico, 64460
      • Monterrey, Mexico, 64320
      • Monterrey, Mexico, 64410
      • Pachuca, Hidalgo, Mexico, 42039
  • Panama
      • Panama, Panama
  • Puerto Rico
      • Ponce, Puerto Rico, 00732-7994
  • Romania
      • Arad, Romania, 2900
      • Brasov, Romania, 500326
      • Bucuresti, Romania, 7000
      • Bucuresti, Romania, 020475
      • Craiova, Romania, 1100
      • Galati, Romania, 6200
      • Ploiesti, Romania, 2000
      • Targoviste, Romania, 0200
      • Tirgu-mures, Romania, 4300
  • Switzerland
      • Meyrin, Switzerland, 1217
  • United Kingdom
      • Bracknell, United Kingdom, RG12 1HX
      • Nottingham, United Kingdom, NG2 3HF
  • United States
    • Florida
      • Hollywood, Florida, United States, 33021
    • North Carolina
      • Durham, North Carolina, United States, 27710
      • Morrisville, North Carolina, United States, 27560
    • Oregon
      • Portland, Oregon, United States, 97239
      • Portland, Oregon, United States, 97219
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
    • South Carolina
      • Greer, South Carolina, United States, 29651
    • Tennessee
      • Memphis, Tennessee, United States, 38119
      • Memphis, Tennessee, United States, 38163
    • Texas
      • Dallas, Texas, United States, 75230
      • Houston, Texas, United States, 77030
      • Midland, Texas, United States, 79705
    • Virginia
      • Lebanon, Virginia, United States, 24266
      • Virginia Beach, Virginia, United States, 23451

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RO 205-2349 2 mg QD
RO 205-2349 2 mg was taken once daily (QD) for 16 weeks during the double-blind treatment period.
Drug: RO 205-2349
Other Names:
  • Edaglitazone
Experimental: RO 205-2349 5 mg QD
RO 205-2349 5 mg was taken once daily (QD) for 16 weeks during the double-blind treatment period.
Drug: RO 205-2349
Other Names:
  • Edaglitazone

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2003

Primary Completion (Actual)

March 1, 2004

Study Completion (Actual)

March 1, 2004

Study Registration Dates

First Submitted

March 31, 2003

First Submitted That Met QC Criteria

March 31, 2003

First Posted (Estimate)

April 1, 2003

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 27, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BM17151

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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