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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00057304
First received: March 31, 2003
Last updated: June 23, 2005
Last verified: November 2004
History of Changes
  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 2 to 5 mg/day will be studied.


Condition Intervention Phase
Diabetes
 Drug: Insulin sensitizer
 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

  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: NCT00057304

  Show 46 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00057304     History of Changes
Other Study ID Numbers: BM17151
Study First Received: March 31, 2003
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 17, 2013