Study to Determine the Efficacy, Safety, Tolerability & Pharmacokinetics of RO 205-2349 in Patients With Type 2 Diabetes Mellitus
Phase 2
Completed
- Conditions
- Diabetes
- Interventions
- Drug: RO 205-2349
- Registration Number
- NCT00057304
- 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 2 to 5 mg/day will be studied.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 190
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RO 205-2349 2 mg QD RO 205-2349 RO 205-2349 2 mg was taken once daily (QD) for 16 weeks during the double-blind treatment period. RO 205-2349 5 mg QD RO 205-2349 RO 205-2349 5 mg was taken once daily (QD) for 16 weeks during the double-blind treatment period.
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method