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

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

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
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

Locations

United States, Arizona

Phoenix, Arizona, United States, 85029

Tucson, Arizona, United States, 85705
United States, California

Chula Vista, California, United States, 91911

Orange, California, United States, 92869

Mission Viejo, California, United States, 92691

San Diego, California, United States, 92117

Santa Ana, California, United States, 92701

Tustin, California, United States, 92780

Paramount, California, United States, 90723

Los Angeles, California, United States
United States, Colorado

Colorado Springs, Colorado, United States, 80909
United States, Florida

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

Shawnee Mission, Kansas, United States, 66216
United States, Louisiana

Shreveport, Louisiana, United States, 71101
United States, Michigan

Dearborn, Michigan, United States, 48126
United States, Missouri

St. Louis, Missouri, United States, 63110
United States, Nebraska

Omaha, Nebraska, United States, 68154
United States, New Jersey

Elizabeth, New Jersey, United States, 07202
United States, North Carolina

Charlotte, North Carolina, United States, 28211
United States, Oklahoma

Oklahoma City, Oklahoma, United States, 73103
United States, Rhode Island

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

San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Incyte Corporation

More Information

No publications provided

Responsible Party:	Incyte Corporation ( Pam Murphy, VP Investor Relations and Corporate Communication )
Study ID Numbers:	INCB 19602-201
Study First Received:	June 13, 2008
Last Updated:	February 23, 2009
ClinicalTrials.gov Identifier:	NCT00698789 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Metformin
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009