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

Roche

Status and phase: Completed; Phase 2

Conditions: Diabetes

Treatments: Drug: RO 205-2349

Study type: Interventional

Funder types: Industry

Identifiers

NCT00057304

BM17151

Details and patient eligibility

About

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.

Enrollment: 190 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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190 participants in 2 patient groups

RO 205-2349 2 mg QD

Experimental group

Description:

RO 205-2349 2 mg was taken once daily (QD) for 16 weeks during the double-blind treatment period.

Treatment:

Drug: RO 205-2349

RO 205-2349 5 mg QD

Experimental group

Description:

RO 205-2349 5 mg was taken once daily (QD) for 16 weeks during the double-blind treatment period.

Treatment:

Drug: RO 205-2349