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

Phase 2

Completed

• Conditions: Diabetes

• Registration Number: NCT00057317
• Lead Sponsor: Hoffmann-La Roche

Brief 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 5 to 20 mg/day will be studied.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-12
• Study First Submitted: 2003-03-31
• Study First Submitted QC: 2003-03-31
• Study First Posted: 2003-04-01
• Primary Completion: 2003-12
• Study Completion: 2003-12
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-23
• Last Update Posted: 2016-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified