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

This study has been completed.

Sponsor:

Information provided by:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00057304

First received: March 31, 2003

Last updated: June 23, 2005

Last verified: November 2004

History of Changes

Tracking Information
First Received Date ^ICMJE	March 31, 2003
Last Updated Date	June 23, 2005
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00057304 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study to Determine the Efficacy, Safety, Tolerability & Pharmacokinetics of RO 205-2349 in Patients With Type 2 Diabetes Mellitus
Official Title ^ICMJE	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
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Primary Purpose: Treatment
Condition ^ICMJE	Diabetes
Intervention ^ICMJE	Drug: Insulin sensitizer
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	35 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Bulgaria, Estonia, Mexico, Panama, Puerto Rico, Romania, Switzerland, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00057304
Other Study ID Numbers ^ICMJE	BM17151
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Hoffmann-La Roche
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Hoffmann-La Roche
Verification Date	November 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top