CClinicalTrials.gg
TerminatedNCT00698789Updated Oct 30, 2012

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

A Phase 2 interventional study of INCB019602 and INCB019602 in Type 2 Diabetes, sponsored by Incyte Corporation. Terminated at 22 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-10-30.

Sponsored by Incyte Corporation · Phase 2, Interventional, and Treatment

Why this study was terminated
Study ended after diabetes development plan review. .
Phase
Phase 2
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Type 2 Diabetes
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 48 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Incyte Corporation is the lead sponsor of 286 studies on the registry; 37 are open to participants now.

Of its 144 completed or terminated interventional studies of FDA-regulated products, 93 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Established diagnosis of T2D
  • Currently taking metformin monotherapy at a stable dose level
  • FPG between 150 and 270 mg/dL

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Treatment A

    5 mg of INCB019602 in AM with placebo administration in PM

    Drug: INCB019602 · Drug: Placebo · Drug: Metformin

  • Experimental
    Treatment B

    20 mg of INCB019602 in AM with placebo administration in PM

    Drug: INCB019602 · Drug: Placebo · Drug: Metformin

  • Experimental
    Treatment C

    5 mg of INCB019602 in PM with placebo administration in AM

    Drug: INCB019602 · Drug: Placebo · Drug: Metformin

  • Experimental
    Treatment D

    20 mg of INCB019602 in PM with placebo administration in AM

    Drug: INCB019602 · Drug: Placebo · Drug: Metformin

  • 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 · Drug: Placebo · Drug: Metformin

  • Placebo comparator
    Treatment F

    Placebo BID

    Drug: Placebo · Drug: Metformin

Interventions

  • DrugINCB019602

    5 mg of INCB019602 in AM with placebo administration in PM

  • DrugINCB019602

    20 mg in AM with placebo administration in PM

  • DrugINCB019602

    5 mg in PM with placebo administration in AM

  • DrugINCB019602

    20 mg in PM with placebo administration in AM

  • DrugINCB019602

    7.5 mg in PM QoD with placebo administration in AM as well as PM on non-active dose days

  • DrugPlacebo

    Placebo administration in AM or PM depending on treatment arm dosing regimen.

  • DrugMetformin

    Stable dose metformin monotherapy

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Change from Baseline in fasting plasma glucose and population pharmacokinetics of INCB019602 in type 2 diabetic patients.

    Time frame: End of Study

07

Study locations

22 sites
  • Phoenix, Arizona 85029, United States
  • Tucson, Arizona 85705, United States
  • Chula Vista, California 91911, United States
  • Los Angeles, California, United States
  • Mission Viejo, California 92691, United States
  • Orange, California 92869, United States
  • Paramount, California 90723, United States
  • San Diego, California 92117, United States
  • Santa Ana, California 92701, United States
  • Tustin, California 92780, United States
  • Colorado Springs, Colorado 80909, United States
  • St. Petersburg, Florida 33709, United States
  • Shawnee Mission, Kansas 66216, United States
  • Shreveport, Louisiana 71101, United States
  • Dearborn, Michigan 48126, United States
  • St. Louis, Missouri 63110, United States
  • Omaha, Nebraska 68154, United States
  • Elizabeth, New Jersey 07202, United States
  • Charlotte, North Carolina 28211, United States
  • Oklahoma City, Oklahoma 73103, United States
  • East Providence, Rhode Island 02914, United States
  • San Antonio, Texas 78229, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00698789
Lead sponsor
Incyte Corporation
Responsible party
Sponsor
First posted
Jun 17, 2008
Start date
May 2008
Primary completion
Feb 2009
Completion
Jun 2009
Last update
Oct 30, 2012

Study contacts

William V Williams, MD
study director · Incyte Corporation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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