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

October 25, 2012 updated by: Incyte Corporation

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

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

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85029
      • Tucson, Arizona, United States, 85705
    • 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
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
    • Florida
      • St. Petersburg, Florida, United States, 33709
    • Kansas
      • Shawnee Mission, Kansas, United States, 66216
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
    • Michigan
      • Dearborn, Michigan, United States, 48126
    • Missouri
      • St. Louis, Missouri, United States, 63110
    • Nebraska
      • Omaha, Nebraska, United States, 68154
    • New Jersey
      • Elizabeth, New Jersey, United States, 07202
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
    • Texas
      • San Antonio, Texas, United States, 78229

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: INCB019602
20 mg in AM with placebo administration in PM
Drug: INCB019602
5 mg in PM with placebo administration in AM
Drug: INCB019602
20 mg in PM with placebo administration in AM
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
Experimental: Treatment B
20 mg of INCB019602 in AM with placebo administration in PM
Drug: INCB019602
5 mg of INCB019602 in AM with placebo administration in PM
Drug: INCB019602
20 mg in AM with placebo administration in PM
Drug: INCB019602
5 mg in PM with placebo administration in AM
Drug: INCB019602
20 mg in PM with placebo administration in AM
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
Experimental: Treatment C
5 mg of INCB019602 in PM with placebo administration in AM
Drug: INCB019602
5 mg of INCB019602 in AM with placebo administration in PM
Drug: INCB019602
20 mg in AM with placebo administration in PM
Drug: INCB019602
5 mg in PM with placebo administration in AM
Drug: INCB019602
20 mg in PM with placebo administration in AM
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
Experimental: Treatment D
20 mg of INCB019602 in PM with placebo administration in AM
Drug: INCB019602
5 mg of INCB019602 in AM with placebo administration in PM
Drug: INCB019602
20 mg in AM with placebo administration in PM
Drug: INCB019602
5 mg in PM with placebo administration in AM
Drug: INCB019602
20 mg in PM with placebo administration in AM
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
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
5 mg of INCB019602 in AM with placebo administration in PM
Drug: INCB019602
20 mg in AM with placebo administration in PM
Drug: INCB019602
5 mg in PM with placebo administration in AM
Drug: INCB019602
20 mg in PM with placebo administration in AM
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
End of Study

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in fasting plasma glucose and population pharmacokinetics of INCB019602 in type 2 diabetic patients.
Time Frame: End of Study
End of Study

Collaborators and Investigators

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

Sponsor

Incyte Corporation

Investigators

  • Study Director: William V Williams, MD, Incyte Corporation

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)

February 1, 2009

Study Completion (Actual)

June 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 (Estimate)

October 30, 2012

Last Update Submitted That Met QC Criteria

October 25, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB 19602-201

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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