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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00057304

Enrollment

190

Registered

2003-04-01

Start date

2003-06-30

Completion date

2004-03-31

Last updated

2023-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

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.

Interventions

DRUGRO 205-2349

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Intervention model description

All potential participants entered the placebo run-in phase. At the end of the placebo run-in phase, eligible participants who met the final inclusion/exclusion criteria were randomized to the double-blind treatment period. treatment

Eligibility

Sex/Gender

ALL

Age

35 Years to 75 Years

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

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026