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

This study has been terminated.
(Study ended after diabetes development plan review. .)
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT00698789
First received: June 13, 2008
Last updated: October 25, 2012
Last verified: October 2012
  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
Drug: Metformin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]

Enrollment: 48
Study Start Date: May 2008
Study Completion Date: June 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A
5 mg of INCB019602 in AM with placebo administration in PM
Drug: INCB019602
5 mg of INCB019602 in AM with placebo administration in PM
Drug: Placebo
Placebo administration in AM or PM depending on treatment arm dosing regimen.
Drug: Metformin
Stable dose metformin monotherapy
Experimental: Treatment B
20 mg of INCB019602 in AM with placebo administration in PM
Drug: INCB019602
20 mg in AM with placebo administration in PM
Drug: Placebo
Placebo administration in AM or PM depending on treatment arm dosing regimen.
Drug: Metformin
Stable dose metformin monotherapy
Experimental: Treatment C
5 mg of INCB019602 in PM with placebo administration in AM
Drug: INCB019602
5 mg in PM with placebo administration in AM
Drug: Placebo
Placebo administration in AM or PM depending on treatment arm dosing regimen.
Drug: Metformin
Stable dose metformin monotherapy
Experimental: Treatment D
20 mg of INCB019602 in PM with placebo administration in AM
Drug: INCB019602
20 mg in PM with placebo administration in AM
Drug: Placebo
Placebo administration in AM or PM depending on treatment arm dosing regimen.
Drug: Metformin
Stable dose metformin monotherapy
Experimental: Treatment E
7.5 mg of INCB019602 in PM QoD with placebo administration in AM as well as PM on non active dose days
Drug: INCB019602
7.5 mg in PM QoD with placebo administration in AM as well as PM on non-active dose days
Drug: Placebo
Placebo administration in AM or PM depending on treatment arm dosing regimen.
Drug: Metformin
Stable dose metformin monotherapy
Placebo Comparator: Treatment F
Placebo BID
Drug: Placebo
Placebo administration in AM or PM depending on treatment arm dosing regimen.
Drug: Metformin
Stable dose metformin monotherapy

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Los Angeles, California, United States
Mission Viejo, California, United States, 92691
Orange, California, United States, 92869
Paramount, California, United States, 90723
San Diego, California, United States, 92117
Santa Ana, California, United States, 92701
Tustin, California, United States, 92780
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
Investigators
Study Director: William V Williams, MD Incyte Corporation
  More Information

No publications provided

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT00698789     History of Changes
Other Study ID Numbers: INCB 19602-201
Study First Received: June 13, 2008
Last Updated: October 25, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014