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NCT00057304 Clinical Trial

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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00057304
Other study ID # BM17151
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 2003
Est. completion date March 2004

Study information
Verified date April 2023
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 190
Est. completion date March 2004
Est. primary completion date March 2004
Accepts healthy volunteers No
Gender All
Age group 35 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• RO 205-2349

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Bulgaria,  Estonia,  Mexico,  Panama,  Puerto Rico,  Romania,  Switzerland,  United Kingdom, 

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