Evaluate the Safety and Tolerability of INCB019602 When Administered With Metformin in Patients With Type 2 Diabetes - Tabular View

Tracking Information
First Received Date ^ICMJE	June 13, 2008
Last Updated Date	February 23, 2009
Start Date ^ICMJE	May 2008
Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 16, 2008)	Safety and tolerability as determined by monitoring of AEs, vital signs, ECGs, physical examinations, and clinical laboratory blood and urine parameters. [ Time Frame: End of Study ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00698789 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 16, 2008)	Change from Baseline in fasting plasma glucose and population pharmacokinetics of INCB019602 in type 2 diabetic patients. [ Time Frame: End of Study ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Evaluate the Safety and Tolerability of INCB019602 When Administered With Metformin in Patients With Type 2 Diabetes
Official Title ^ICMJE	A Double-Blind, Placebo Controlled, Randomized Study to Evaluate the Safety and Tolerability of INCB019602 Plus Metformin Compared to Metformin Alone in Type 2 Diabetic Subjects
Brief Summary	Determine the effect of treatment with INCB019602 administered as an add-on to stable dose metformin therapy in type 2 diabetic subjects on safety and glycemic control.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Condition ^ICMJE	Type 2 Diabetes
Intervention ^ICMJE	Drug: INCB019602 Drug: Placebo
Study Arms / Comparison Groups	Experimental: Dose 1 INCB019602 Experimental: Dose 2 INCB019602 Experimental: Dose 3 INCB019602 Experimental: Dose 4 INCB019602 Experimental: Dose 5 INCB019602 Placebo Comparator: Placebo
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
Estimated Enrollment ^ICMJE	120
Completion Date
Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Established diagnosis of T2D Currently taking metformin monotherapy at a stable dose level FPG between 150 and 270 mg/dL Exclusion Criteria: History or clinical manifestations of renal impairment Hyperglycemia > 270 mg/dL Receiving thiazolidenediones, Exenatide or sulfonylureas within 90 days prior to screening Prior use of Acipimox which is known under the name Olbetam within 90 days prior to screening. Diagnosed major depression within the last 2 years requiring hospitalization History of chronic insulin therapy for glycemic control
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00698789
Responsible Party	Pam Murphy, VP Investor Relations and Corporate Communication, Incyte Corporation
Study ID Numbers ^ICMJE	INCB 19602-201
Study Sponsor ^ICMJE	Incyte Corporation
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Incyte Corporation
Verification Date	February 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP