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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: INCB019602
* Drug: INCB019602
* Drug: INCB019602
* Drug: INCB019602
* Drug: INCB019602
* Drug: Placebo
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>5 mg of INCB019602 in AM with placebo administration in PM | Drug: INCB019602<br>* 5 mg of INCB019602 in AM with placebo administration in PM<br>Drug: Placebo<br>* Placebo administration in AM or PM depending on treatment arm dosing regimen.<br>Drug: Metformin<br>* Stable dose metformin monotherapy<br>|
| Experimental: Treatment B<br>20 mg of INCB019602 in AM with placebo administration in PM | Drug: INCB019602<br>* 20 mg in AM with placebo administration in PM<br>Drug: Placebo<br>* Placebo administration in AM or PM depending on treatment arm dosing regimen.<br>Drug: Metformin<br>* Stable dose metformin monotherapy<br>|
| Experimental: Treatment C<br>5 mg of INCB019602 in PM with placebo administration in AM | Drug: INCB019602<br>* 5 mg in PM with placebo administration in AM<br>Drug: Placebo<br>* Placebo administration in AM or PM depending on treatment arm dosing regimen.<br>Drug: Metformin<br>* Stable dose metformin monotherapy<br>|
| Experimental: Treatment D<br>20 mg of INCB019602 in PM with placebo administration in AM | Drug: INCB019602<br>* 20 mg in PM with placebo administration in AM<br>Drug: Placebo<br>* Placebo administration in AM or PM depending on treatment arm dosing regimen.<br>Drug: Metformin<br>* Stable dose metformin monotherapy<br>|
| Experimental: Treatment E<br>7.5 mg of INCB019602 in PM QoD with placebo administration in AM as well as PM on non active dose days | Drug: INCB019602<br>* 7.5 mg in PM QoD with placebo administration in AM as well as PM on non-active dose days<br>Drug: Placebo<br>* Placebo administration in AM or PM depending on treatment arm dosing regimen.<br>Drug: Metformin<br>* Stable dose metformin monotherapy<br>|
| Placebo Comparator: Treatment F<br>Placebo BID | Drug: Placebo<br>* Placebo administration in AM or PM depending on treatment arm dosing regimen.<br>Drug: Metformin<br>* Stable dose metformin monotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability as determined by monitoring of AEs, vital signs, ECGs, physical examinations, and clinical laboratory blood and urine parameters. |  | End of Study | 

Secondary Outcome Measures

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