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Study of Ro 205-2349 in Patients With Type 2 Diabetes Mellitus

This study has been completed.

Sponsored by: Hoffmann-La Roche
Information provided by: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00057317
  Purpose

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 5 to 20 mg/day will be studied.


Condition Intervention Phase
Diabetes
Drug: Ro 205-2349
Phase II

MedlinePlus related topics:   Diabetes   

ChemIDplus related topics:   Ro 205-2349   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Official Title:   A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Determine the Efficacy, Safety, Tolerability and Pharmacokinetics of Ro 205-2349 in Patients With Type 2 Diabetes Mellitus
  Eligibility
Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057317

Show 118 study locations  Show 118 Study Locations

Sponsors and Collaborators
Hoffmann-La Roche
  More Information

Study ID Numbers:   WM16177
First Received:   March 31, 2003
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00057317
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on August 28, 2008




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