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

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Pioglitazone 30 mg; Drug: Placebo; Drug: JNJ-41443532

Study type: Interventional

Funder types: Industry

Identifiers

NCT01230749

41443532EDI2001 (Other Identifier)

CR017401

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 89 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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89 participants in 4 patient groups, including a placebo group

JNJ-41443532 250 mg

Experimental group

Description:

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

Treatment:

Drug: JNJ-41443532

Drug: Placebo

JNJ-41443532 1000 mg

Experimental group

Description:

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

Treatment:

Drug: JNJ-41443532

Drug: Placebo

Pioglitazone

Active Comparator group

Description:

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

Treatment:

Drug: Pioglitazone 30 mg

Drug: Placebo

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo