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

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: INCB019602 Drug: Placebo	Phase II

MedlinePlus related topics:

Diabetes

Drug Information available for:

Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study

Official Title:	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

Further study details as provided by Incyte Corporation:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	120
Study Start Date:	May 2008
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Dose 1 INCB019602	Drug: INCB019602 INCB019602
B: Experimental Dose 2 INCB019602	Drug: INCB019602 INCB019602
C: Experimental Dose 3 INCB019602	Drug: INCB019602 INCB019602
D: Experimental Dose 4 INCB019602	Drug: INCB019602 INCB019602
E: Experimental Dose 5 INCB019602	Drug: INCB019602 INCB019602
G: Placebo Comparator Placebo	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698789

Contacts


Contact: Jill Bowman	302-498-6746	jbowman@incyte.com

Locations


United States, Arizona
		Recruiting
	Phoenix, Arizona, United States, 85029
		Recruiting
	Tucson, Arizona, United States, 85705

United States, California
		Recruiting
	Chula Vista, California, United States, 91911
		Recruiting
	Orange, California, United States, 92869
		Recruiting
	Mission Viejo, California, United States, 92691
		Recruiting
	San Diego, California, United States, 92117
		Recruiting
	Santa Ana, California, United States, 92701
		Recruiting
	Tustin, California, United States, 92780
		Recruiting
	Paramount, California, United States, 90723
		Recruiting
	Los Angeles, California, United States

United States, Colorado
		Recruiting
	Colorado Springs, Colorado, United States, 80909

United States, Florida
		Recruiting
	St. Petersburg, Florida, United States, 33709

United States, Kansas
		Recruiting
	Shawnee Mission, Kansas, United States, 66216

United States, Louisiana
		Recruiting
	Shreveport, Louisiana, United States, 71101

United States, Michigan
		Recruiting
	Dearborn, Michigan, United States, 48126

United States, Missouri
		Not yet recruiting
	St. Louis, Missouri, United States, 63110

United States, Nebraska
		Not yet recruiting
	Omaha, Nebraska, United States, 68154

United States, New Jersey
		Recruiting
	Elizabeth, New Jersey, United States, 07202

United States, North Carolina
		Recruiting
	Charlotte, North Carolina, United States, 28211

United States, Oklahoma
		Recruiting
	Oklahoma City, Oklahoma, United States, 73103

United States, Rhode Island
		Recruiting
	East Providence, Rhode Island, United States, 02914

United States, Texas
		Recruiting
	San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Incyte Corporation

More Information

Responsible Party:	Incyte Corporation ( Pam Murphy, VP Investor Relations and Corporate Communication )
Study ID Numbers:	INCB 19602-201
First Received:	June 13, 2008
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00698789
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases

Metformin

Diabetes Mellitus, Type 2

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Additional relevant MeSH terms:

Hypoglycemic Agents

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 19, 2008

Sponsored by:	Incyte Corporation
Information provided by:	Incyte Corporation
ClinicalTrials.gov Identifier:	NCT00698789