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

Diabetes Clinical Trial

Official title:

A Phase II, Randomized, Double-blind, Placebo-controlled Dose-ranging Study to Determine the Efficacy, Safety, Tolerability and Pharmacokinetics of Ro 205-2349 in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00057317
• Other study ID #: WM16177
• Status: Completed
• Phase: Phase 2
• First received: March 31, 2003
• Last updated: August 23, 2016
• Start date: December 2001
• Est. completion date: December 2003

Study information

• Verified date: August 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• 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 5 to 20 mg/day will be studied.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2003
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

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,  Canada,  Estonia,  Latvia,  Lithuania,  Mexico,  Panama,  Puerto Rico,  Romania,  United Kingdom,