Safety and Efficacy of INCB013739 Plus Metformin Compared to Metformin Alone on Glycemic Control in Type 2 Diabetics

Phase 2

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: INCB013739; Drug: Placebo comparator matching INCB013739; Drug: Metformin

• Registration Number: NCT00698230
• Lead Sponsor: Incyte Corporation

Brief Summary

Determine the effect of treatment with INCB013739 administered as an 'add-on' to metformin therapy in type 2 diabetic subjects on safety and tolerability 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: 2009-04
• Study Completion: 2009-05
• Disposition First Submitted: 2010-06-17
• Disposition First Submitted QC: 2010-06-17
• Disposition First Posted: 2010-06-22
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-12
• Last Update Posted: 2018-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

Inclusion Criteria

• Established diagnosis of Type 2 Diabetes
• Stable dose of metformin for more than 8 weeks

Exclusion Criteria

• Subjects with Addison's disease or Cushing's Syndrome
• Type 1 diabetes mellitus or secondary forms of diabetes
• Subjects with uncontrolled thyroid disease
• History of renal impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment B - INCB013739 & Metformin	INCB013739	INCB013739 15 mg QD and Metformin
Treatment C - INCB013739 & Metformin	INCB013739	INCB013739 50 mg QD and Metformin
Treatment A - INCB013739 & Metformin	INCB013739	INCB013739 5 mg QD and Metformin
Treatment D - INCB013739 & Metformin	INCB013739	INCB013739 100 mg QD and Metformin
Treatment B - INCB013739 & Metformin	Metformin	INCB013739 15 mg QD and Metformin
Treatment F - Placebo	Placebo comparator matching INCB013739	Matching placebo
Treatment E - INCB013739 & Metformin	INCB013739	INCB013739 200 mg QD and Metformin
Treatment E - INCB013739 & Metformin	Metformin	INCB013739 200 mg QD and Metformin
Treatment A - INCB013739 & Metformin	Metformin	INCB013739 5 mg QD and Metformin
Treatment C - INCB013739 & Metformin	Metformin	INCB013739 50 mg QD and Metformin
Treatment D - INCB013739 & Metformin	Metformin	INCB013739 100 mg QD and Metformin

Primary Outcome Measures

Name	Time	Method
Change from Baseline to Week 12 in hemoglobin A1c (HbA1c)	Baseline and Week 12 (or early termination study visit)

Secondary Outcome Measures

Name	Time	Method
Change from Baseline to Week 12 in fasting plasma glucose (FPG).	Baseline and Week 12 (or early termination study visit)