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

Primary Purpose

Type 2 Diabetes

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

INCB019602

Placebo

Metformin

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment A

Treatment B

Treatment C

Treatment D

Treatment E

Treatment F

Arm Description

5 mg of INCB019602 in AM with placebo administration in PM

20 mg of INCB019602 in AM with placebo administration in PM

5 mg of INCB019602 in PM with placebo administration in AM

20 mg of INCB019602 in PM with placebo administration in AM

7.5 mg of INCB019602 in PM QoD with placebo administration in AM as well as PM on non active dose days

Placebo BID

Outcomes

Primary Outcome Measures

Safety and tolerability as determined by monitoring of AEs, vital signs, ECGs, physical examinations, and clinical laboratory blood and urine parameters.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00698789

First Posted

June 13, 2008

Last Updated

October 25, 2012

Sponsor

Incyte Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00698789

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Terminated

Why Stopped

Study ended after diabetes development plan review. .

Study Start Date

May 2008 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Incyte Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment A

Arm Type

Experimental

Arm Description

5 mg of INCB019602 in AM with placebo administration in PM

Arm Title

Treatment B

Arm Type

Experimental

Arm Description

20 mg of INCB019602 in AM with placebo administration in PM

Arm Title

Treatment C

Arm Type

Experimental

Arm Description

5 mg of INCB019602 in PM with placebo administration in AM

Arm Title

Treatment D

Arm Type

Experimental

Arm Description

20 mg of INCB019602 in PM with placebo administration in AM

Arm Title

Treatment E

Arm Type

Experimental

Arm Description

7.5 mg of INCB019602 in PM QoD with placebo administration in AM as well as PM on non active dose days

Arm Title

Treatment F

Arm Type

Placebo Comparator

Arm Description

Placebo BID

Intervention Type

Drug

Intervention Name(s)

INCB019602

Intervention Description

5 mg of INCB019602 in AM with placebo administration in PM

Intervention Type

Drug

Intervention Name(s)

INCB019602

Intervention Description

20 mg in AM with placebo administration in PM

Intervention Type

Drug

Intervention Name(s)

INCB019602

Intervention Description

5 mg in PM with placebo administration in AM

Intervention Type

Drug

Intervention Name(s)

INCB019602

Intervention Description

20 mg in PM with placebo administration in AM

Intervention Type

Drug

Intervention Name(s)

INCB019602

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

Stable dose metformin monotherapy

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

Time Frame

End of Study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William V Williams, MD

Organizational Affiliation

Incyte Corporation

Official's Role

Study Director

Facility Information:

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85029

Country

United States

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85705

Country

United States

City

Chula Vista

State/Province

California

ZIP/Postal Code

91911

Country

United States

City

Los Angeles

State/Province

California

Country

United States

City

Mission Viejo

State/Province

California

ZIP/Postal Code

92691

Country

United States

City

Orange

State/Province

California

ZIP/Postal Code

92869

Country

United States

City

Paramount

State/Province

California

ZIP/Postal Code

90723

Country

United States

City

San Diego

State/Province

California

ZIP/Postal Code

92117

Country

United States

City

Santa Ana

State/Province

California

ZIP/Postal Code

92701

Country

United States

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80909

Country

United States

City

St. Petersburg

State/Province

Florida

ZIP/Postal Code

33709

Country

United States

City

Shawnee Mission

State/Province

Kansas

ZIP/Postal Code

66216

Country

United States

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71101

Country

United States

City

Dearborn

State/Province

Michigan

ZIP/Postal Code

48126

Country

United States

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68154

Country

United States

City

Elizabeth

State/Province

New Jersey

ZIP/Postal Code

07202

Country

United States

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28211

Country

United States

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

City

East Providence

State/Province

Rhode Island

ZIP/Postal Code

02914

Country

United States

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

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

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