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

NCT00698789 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2012-10-30

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • William V Williams, MD · Incyte Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-02-28
Completion
2009-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00698789 on ClinicalTrials.gov