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

This study has been completed.
Information provided by:
Hoffmann-La Roche Identifier:
First received: March 31, 2003
Last updated: August 23, 2016
Last verified: August 2016
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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
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

Further study details as provided by Hoffmann-La Roche:

Study Start Date: December 2001
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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
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Please refer to this study by its identifier: NCT00057317

  Show 117 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
  More Information Identifier: NCT00057317     History of Changes
Other Study ID Numbers: WM16177
Study First Received: March 31, 2003
Last Updated: August 23, 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on August 21, 2017