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A Study of Multiple Oral Doses of JNJ-41443532 in Patients With Type 2 Diabetes Mellitus

NCT ID: NCT01230749

Last Updated: 2013-12-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-06-30

Brief Summary

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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (what the body does to the medication) and pharmacodynamics (what the medication does to the body) of treatment with JNJ-41443532 relative to treatment with placebo in type 2 diabetes mellitus participants.

Detailed Description

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This is a randomized (the study medication is assigned by chance), double-blind (neither investigator nor participant knows the treatment that the participant receives), multicenter (study conducted at multiple sites), and placebo (an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study) and active comparator (an established effective treatment that is compared with a medication to test whether the medication has a real effect in a clinical study) controlled study (placebo or active comparator is compared with the study medication to test whether the study medication has a real effect in clinical study). The study consists of 4 phases: screening phase (45 days before administration of study medication); pre-dosing run-in phase (a phase before a clinical study is commenced when no treatment is given. In this study, participant's glucose level will be observed during run-in-phase: days 15 to 1 before administration of study medication); treatment phase, and follow-up phase (7 to 10 days after the last dose of the study medication). Approximately 88 participants will be enrolled in this study. All participants will be randomly assigned to 4 treatment arms: JNJ-41443532 250 mg; JNJ-41443532 1000 mg; pioglitazone arm; and placebo. Safety evaluations will include assessment of adverse events including ocular assessments, clinical laboratory tests, electrocardiogram, vital signs, and physical examination which will be monitored throughout the study. The maximum study duration for each participant will be approximately 12 weeks.

Conditions

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Diabetes Mellitus, Type 2

Keywords

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Diabetes Mellitus, Type 2 Diabetes Mellitus Hyperglycemia JNJ-41443532 Pioglitazone Placebo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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JNJ-41443532 250 mg

Participants will receive JNJ-41443532 250 mg in morning and evening for 28 days.

Group Type EXPERIMENTAL

JNJ-41443532

Intervention Type DRUG

Participants will receive JNJ-41443532 tablet(s) orally in JNJ-41443532 250 mg arm (1 X 250 mg) and JNJ-41443532 1000 mg arm (4 X 250 mg) in morning and evening, for 28 days.

Placebo

Intervention Type DRUG

Participants will receive matching placebo tablets of JNJ-41443532 and/or matching placebo tablets of pioglitazone orally as per the assigned arms.

JNJ-41443532 1000 mg

Participants will receive JNJ-41443532 1000 mg (4 X 250 mg) in morning and evening for 28 days.

Group Type EXPERIMENTAL

JNJ-41443532

Intervention Type DRUG

Participants will receive JNJ-41443532 tablet(s) orally in JNJ-41443532 250 mg arm (1 X 250 mg) and JNJ-41443532 1000 mg arm (4 X 250 mg) in morning and evening, for 28 days.

Placebo

Intervention Type DRUG

Participants will receive matching placebo tablets of JNJ-41443532 and/or matching placebo tablets of pioglitazone orally as per the assigned arms.

Pioglitazone

Participants will receive pioglitazone 30 mg in morning for 28 days.

Group Type ACTIVE_COMPARATOR

Pioglitazone 30 mg

Intervention Type DRUG

Participants will receive tablet pioglitazone 30 mg orally in morning for 28 days.

Placebo

Intervention Type DRUG

Participants will receive matching placebo tablets of JNJ-41443532 and/or matching placebo tablets of pioglitazone orally as per the assigned arms.

Placebo

Participants will receive matching placebo for JNJ-41443532 and pioglitazone for 28 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will receive matching placebo tablets of JNJ-41443532 and/or matching placebo tablets of pioglitazone orally as per the assigned arms.

Interventions

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JNJ-41443532

Participants will receive JNJ-41443532 tablet(s) orally in JNJ-41443532 250 mg arm (1 X 250 mg) and JNJ-41443532 1000 mg arm (4 X 250 mg) in morning and evening, for 28 days.

Intervention Type DRUG

Pioglitazone 30 mg

Participants will receive tablet pioglitazone 30 mg orally in morning for 28 days.

Intervention Type DRUG

Placebo

Participants will receive matching placebo tablets of JNJ-41443532 and/or matching placebo tablets of pioglitazone orally as per the assigned arms.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosed Type 2 Diabetes Mellitus (T2DM) for at least 3 months prior screening
* On a stable treatment regimen for at least 2 months prior screening
* Medically stable on the basis of physical examination, medical history, and clinical laboratory tests performed at screening and 2 days before administration of the study medication
* Fasting plasma glucose (FPG) concentrations between 140 mg/dL and 270 mg/dL on 2 days before administration of the study medication
* Agrees to protocol-defined use of effective contraception

Exclusion Criteria

* History of other types of diabetes and complications or secondary forms of diabetes
* History of eating disorder or recent significant changes in body weight (ie, more or equal to 5 percent over 3 months prior to screening) due to dieting or nutritional treatments
* Taking antihyperglycemic agents (insulin, exenatide, and liraglutide) within 6 months or thiazolidinedione within 3 months of 2 days before administration of the study medication
* Clinically significant abnormal electrocardiogram
* History of, or currently active, significant illness or medical disorders, retinal disease, tuberculosis
* Clinically important serious infection, positive for serology at screening (hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus antibodies)
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Countries

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United States

Other Identifiers

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41443532EDI2001

Identifier Type: OTHER

Identifier Source: secondary_id

CR017401

Identifier Type: -

Identifier Source: org_study_id