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CompletedNCT00057304Updated Apr 28, 2023

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

A Phase 2 interventional study of RO 205-2349 in Diabetes, sponsored by Hoffmann-La Roche. Completed at 46 sites in 9 countries. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-28.

Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
190
Allocation
Randomized
Ages
35 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 190 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
190 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugRO 205-2349

    Also known as: Edaglitazone

06

Study locations

46 sites
  • Hollywood, Florida 33021, United States
  • Durham, North Carolina 27710, United States
  • Morrisville, North Carolina 27560, United States
  • Portland, Oregon 97219, United States
  • Portland, Oregon 97239, United States
  • Camp Hill, Pennsylvania 17011, United States
  • Greer, South Carolina 29651, United States
  • Memphis, Tennessee 38119, United States
  • Memphis, Tennessee 38163, United States
  • Dallas, Texas 75230, United States
  • Houston, Texas 77030, United States
  • Midland, Texas 79705, United States
  • Lebanon, Virginia 24266, United States
  • Virginia Beach, Virginia 23451, United States
  • Pleven, 5800, Bulgaria
  • Plovdiv, 4002, Bulgaria
  • Sofia, 1233, Bulgaria
  • Sofia, 1431, Bulgaria
  • Sofia, 1606, Bulgaria
  • Tallinn, 10138, Estonia
  • Tartu, 50406, Estonia
  • Tartu, 50708, Estonia
  • Voru, 65609, Estonia
  • Chihuahua, Chih., Mexico
  • Guadalajara, JAL., 44340, Mexico
  • Guadalajara, 44349, Mexico
  • Merida, 97000, Mexico
  • Mexico City, 06700, Mexico
  • Monterrey, 64320, Mexico
  • Monterrey, 64410, Mexico
  • Monterrey, 64460, Mexico
  • Pachuca, Hidalgo, 42039, Mexico
  • Panama, Panama
  • Ponce, 00732-7994, Puerto Rico
  • Arad, 2900, Romania
  • Brasov, 500326, Romania
  • Bucuresti, 020475, Romania
  • Bucuresti, 7000, Romania
  • Craiova, 1100, Romania
  • Galati, 6200, Romania
  • Ploiesti, 2000, Romania
  • Targoviste, 0200, Romania
  • Tirgu-mures, 4300, Romania
  • Meyrin, 1217, Switzerland
  • Bracknell, RG12 1HX, United Kingdom
  • Nottingham, NG2 3HF, United Kingdom
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00057304
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Apr 1, 2003
Start date
Jun 2003
Primary completion
Mar 2004
Completion
Mar 2004
Last update
Apr 28, 2023
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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