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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 13, 2008

Last Updated Date

October 25, 2012

Start Date ^ICMJE

May 2008

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00698789 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Type 2 Diabetes

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Treatment A
5 mg of INCB019602 in AM with placebo administration in PM
Interventions:
- Drug: INCB019602
- Drug: Placebo
- Drug: Metformin
Experimental: Treatment B
20 mg of INCB019602 in AM with placebo administration in PM
Interventions:
- Drug: INCB019602
- Drug: Placebo
- Drug: Metformin
Experimental: Treatment C
5 mg of INCB019602 in PM with placebo administration in AM
Interventions:
- Drug: INCB019602
- Drug: Placebo
- Drug: Metformin
Experimental: Treatment D
20 mg of INCB019602 in PM with placebo administration in AM
Interventions:
- 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
Interventions:
- Drug: INCB019602
- Drug: Placebo
- Drug: Metformin
Placebo Comparator: Treatment F
Placebo BID
Interventions:
- Drug: Placebo
- Drug: Metformin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

June 2009

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00698789

Other Study ID Numbers ^ICMJE

INCB 19602-201

Has Data Monitoring Committee

Responsible Party

Incyte Corporation

Study Sponsor ^ICMJE

Incyte Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

William V Williams, MD

Incyte Corporation

Information Provided By

Incyte Corporation

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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