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

Incyte

Status and phase: Terminated; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: INCB019602; Drug: Metformin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00698789

INCB 19602-201

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 6 patient groups, including a placebo group

Treatment A

Experimental group

Description:

5 mg of INCB019602 in AM with placebo administration in PM

Treatment:

Drug: INCB019602

Drug: INCB019602

Drug: INCB019602

Drug: INCB019602

Drug: Metformin

Drug: Placebo

Drug: INCB019602

Treatment B

Experimental group

Description:

20 mg of INCB019602 in AM with placebo administration in PM

Treatment:

Drug: INCB019602

Drug: INCB019602

Drug: INCB019602

Drug: INCB019602

Drug: Metformin

Drug: Placebo

Drug: INCB019602

Treatment C

Experimental group

Description:

5 mg of INCB019602 in PM with placebo administration in AM

Treatment:

Drug: INCB019602

Drug: INCB019602

Drug: INCB019602

Drug: INCB019602

Drug: Metformin

Drug: Placebo

Drug: INCB019602

Treatment D

Experimental group

Description:

20 mg of INCB019602 in PM with placebo administration in AM

Treatment:

Drug: INCB019602

Drug: INCB019602

Drug: INCB019602

Drug: INCB019602

Drug: Metformin

Drug: Placebo

Drug: INCB019602

Treatment E

Experimental group

Description:

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

Treatment:

Drug: INCB019602

Drug: INCB019602

Drug: INCB019602

Drug: INCB019602

Drug: Metformin

Drug: Placebo

Drug: INCB019602

Treatment F

Placebo Comparator group

Description:

Placebo BID

Treatment:

Drug: Metformin

Drug: Placebo