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

This study is currently recruiting participants.
Verified by Incyte Corporation, November 2008

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
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




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