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

Phase 2

Terminated

• Conditions: Type 2 Diabetes
• Interventions: Drug: INCB019602; Drug: Placebo; Drug: Metformin

• Registration Number: NCT00698789
• Lead Sponsor: Incyte Corporation

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 available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-06-13
• Study First Submitted QC: 2008-06-16
• Study First Posted: 2008-06-17
• Primary Completion: 2009-02
• Study Completion: 2009-06
• Status Verified: 2012-10
• Disposition First Submitted: 2012-10-11
• Disposition First Submitted QC: 2012-10-11
• Disposition First Posted: 2012-10-15
• Last Update Submitted: 2012-10-25
• Last Update Posted: 2012-10-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment A	INCB019602	5 mg of INCB019602 in AM with placebo administration in PM
Treatment A	Placebo	5 mg of INCB019602 in AM with placebo administration in PM
Treatment A	Metformin	5 mg of INCB019602 in AM with placebo administration in PM
Treatment B	INCB019602	20 mg of INCB019602 in AM with placebo administration in PM
Treatment B	Placebo	20 mg of INCB019602 in AM with placebo administration in PM
Treatment B	Metformin	20 mg of INCB019602 in AM with placebo administration in PM
Treatment C	INCB019602	5 mg of INCB019602 in PM with placebo administration in AM
Treatment C	Placebo	5 mg of INCB019602 in PM with placebo administration in AM
Treatment D	INCB019602	20 mg of INCB019602 in PM with placebo administration in AM
Treatment D	Placebo	20 mg of INCB019602 in PM with placebo administration in AM
Treatment E	INCB019602	7.5 mg of INCB019602 in PM QoD with placebo administration in AM as well as PM on non active dose days
Treatment E	Placebo	7.5 mg of INCB019602 in PM QoD with placebo administration in AM as well as PM on non active dose days
Treatment E	Metformin	7.5 mg of INCB019602 in PM QoD with placebo administration in AM as well as PM on non active dose days
Treatment F	Placebo	Placebo BID
Treatment F	Metformin	Placebo BID
Treatment D	Metformin	20 mg of INCB019602 in PM with placebo administration in AM
Treatment C	Metformin	5 mg of INCB019602 in PM with placebo administration in AM

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change from Baseline in fasting plasma glucose and population pharmacokinetics of INCB019602 in type 2 diabetic patients.	End of Study