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

Tracking Information
First Received Date ^ICMJE	March 31, 2003
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00057317 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of Ro 205-2349 in Patients With Type 2 Diabetes Mellitus
Official Title ^ICMJE	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
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 5 to 20 mg/day will be studied.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Condition ^ICMJE	Diabetes
Intervention ^ICMJE	Drug: Ro 205-2349
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
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, Canada, Estonia, Latvia, Lithuania, Mexico, Panama, Puerto Rico, Romania, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00057317
Responsible Party
Study ID Numbers ^ICMJE	WM16177
Study Sponsor ^ICMJE	Hoffmann-La Roche
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Hoffmann-La Roche
Verification Date	April 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP