Safety and Efficacy of INCB013739 Plus Metformin Compared to Metformin Alone on Glycemic Control in Type 2 Diabetics

February 12, 2018 updated by: Incyte Corporation

Randomized Study to Evaluate the Safety and Efficacy of INCB013739 Plus Metformin Compared to Metformin Alone on Glycemic Control in Type 2 Diabetic Subjects

Determine the effect of treatment with INCB013739 administered as an 'add-on' to metformin therapy in type 2 diabetic subjects on safety and tolerability and glycemic control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

302

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Carolina, Puerto Rico, 00983
      • Fajardo, Puerto Rico, 00738
      • Ponce, Puerto Rico, 00716
      • Rio Grande, Puerto Rico, 00745
      • San Juan, Puerto Rico, 00909-1711
      • San Juan, Puerto Rico, 00926-2832
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35242
    • California
      • Artesia, California, United States
      • Calabasas, California, United States, 91307
      • Fresno, California, United States, 93720
      • Los Angeles, California, United States, 90057
      • Los Gatos, California, United States, 95032
      • Santa Ana, California, United States
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
    • Florida
      • Chiefland, Florida, United States, 32626
      • Hollywood, Florida, United States, 33021
      • Longwood, Florida, United States, 32779
      • Miami, Florida, United States, 33126
      • Miami Beach, Florida, United States, 33140
      • Ocala, Florida, United States, 34471
      • Orlando, Florida, United States, 32806
      • South Miami, Florida, United States, 33143
      • Tampa, Florida, United States, 33614
    • Georgia
      • Dunwoody, Georgia, United States, 30338
      • Rome, Georgia, United States, 30165
    • Illinois
      • Belleville, Illinois, United States, 62220
    • Kansas
      • Shawnee Mission, Kansas, United States, 66216
    • Maine
      • Bangor, Maine, United States, 04401
    • Maryland
      • Columbia, Maryland, United States, 21045
    • Michigan
      • Sterling Heights, Michigan, United States, 48314
    • Missouri
      • Florissant, Missouri, United States, 63031
      • Saint Louis, Missouri, United States, 63141
      • Saint Louis, Missouri, United States, 63128
    • Nevada
      • Las Vegas, Nevada, United States, 89101
    • New York
      • New York, New York, United States, 10016
      • Springfield Gardens, New York, United States, 11413
      • West Seneca, New York, United States, 14224
    • North Carolina
      • Calabash, North Carolina, United States, 95032
      • Mooresville, North Carolina, United States, 28117
      • New Bern, North Carolina, United States, 28562
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Kettering, Ohio, United States, 45429
      • Norton, Ohio, United States, 44614
    • Oklahoma
      • Norman, Oklahoma, United States, 73071
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16601
      • Harleysville, Pennsylvania, United States, 19438
      • Jenkintown, Pennsylvania, United States, 19046
      • Sellersville, Pennsylvania, United States, 18960
    • South Carolina
      • Greenville, South Carolina, United States, 29615
      • North Myrtle Beach, South Carolina, United States, 29582
      • Spartanburg, South Carolina, United States, 29303
    • Tennessee
      • Bristol, Tennessee, United States, 37620
    • Texas
      • Austin, Texas, United States, 78705
      • Dallas, Texas, United States, 75230
      • Georgetown, Texas, United States
      • Houston, Texas, United States, 77004
      • Houston, Texas, United States, 77074
      • Houston, Texas, United States, 77090
      • Houston, Texas, United States, 77023
      • Houston, Texas, United States, 77081
      • Midland, Texas, United States, 79705
      • North Richland Hills, Texas, United States, 76180
      • San Antonio, Texas, United States, 78229
      • Temple, Texas, United States, 76502
      • Waco, Texas, United States, 76710
    • Virginia
      • Burke, Virginia, United States, 22015
      • Hampton, Virginia, United States, 23666
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Established diagnosis of Type 2 Diabetes
  • Stable dose of metformin for more than 8 weeks

Exclusion Criteria:

  • Subjects with Addison's disease or Cushing's Syndrome
  • Type 1 diabetes mellitus or secondary forms of diabetes
  • Subjects with uncontrolled thyroid disease
  • History of renal impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment A - INCB013739 & Metformin
INCB013739 5 mg QD and Metformin
Drug: Metformin
Drug: INCB013739
INCB013739 5 mg QD tablet
Drug: INCB013739
INCB013739 15 mg QD tablet
Drug: INCB013739
INCB013739 50 mg QD tablet
Drug: INCB013739
INCB013739 100 mg QD tablet
Drug: INCB013739
INCB013739 200 mg QD
Experimental: Treatment B - INCB013739 & Metformin
INCB013739 15 mg QD and Metformin
Drug: Metformin
Drug: INCB013739
INCB013739 5 mg QD tablet
Drug: INCB013739
INCB013739 15 mg QD tablet
Drug: INCB013739
INCB013739 50 mg QD tablet
Drug: INCB013739
INCB013739 100 mg QD tablet
Drug: INCB013739
INCB013739 200 mg QD
Experimental: Treatment C - INCB013739 & Metformin
INCB013739 50 mg QD and Metformin
Drug: Metformin
Drug: INCB013739
INCB013739 5 mg QD tablet
Drug: INCB013739
INCB013739 15 mg QD tablet
Drug: INCB013739
INCB013739 50 mg QD tablet
Drug: INCB013739
INCB013739 100 mg QD tablet
Drug: INCB013739
INCB013739 200 mg QD
Experimental: Treatment D - INCB013739 & Metformin
INCB013739 100 mg QD and Metformin
Drug: Metformin
Drug: INCB013739
INCB013739 5 mg QD tablet
Drug: INCB013739
INCB013739 15 mg QD tablet
Drug: INCB013739
INCB013739 50 mg QD tablet
Drug: INCB013739
INCB013739 100 mg QD tablet
Drug: INCB013739
INCB013739 200 mg QD
Experimental: Treatment E - INCB013739 & Metformin
INCB013739 200 mg QD and Metformin
Drug: Metformin
Drug: INCB013739
INCB013739 5 mg QD tablet
Drug: INCB013739
INCB013739 15 mg QD tablet
Drug: INCB013739
INCB013739 50 mg QD tablet
Drug: INCB013739
INCB013739 100 mg QD tablet
Drug: INCB013739
INCB013739 200 mg QD
Placebo Comparator: Treatment F - Placebo
Matching placebo
Drug: Placebo comparator matching INCB013739
Orally once daily tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline to Week 12 in hemoglobin A1c (HbA1c)
Time Frame: Baseline and Week 12 (or early termination study visit)
Baseline and Week 12 (or early termination study visit)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline to Week 12 in fasting plasma glucose (FPG).
Time Frame: Baseline and Week 12 (or early termination study visit)
Baseline and Week 12 (or early termination study visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Investigators

  • Study Director: Bill Williams, MD, Incyte Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

June 13, 2008

First Submitted That Met QC Criteria

June 16, 2008

First Posted (Estimate)

June 17, 2008

Study Record Updates

Last Update Posted (Actual)

February 14, 2018

Last Update Submitted That Met QC Criteria

February 12, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB 13739-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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