NCT00698789

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-02-01
• Completion: 2009-06-01
• First posted: 2008-06-17
• Last updated: 2012-10-30

Locations

22 sites across 1 country: United States