Clinical trial NCT01230749
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2 Diabetes Mellitus Hyperglycemia JNJ-41443532 Pioglitazone Placebo
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Start date: 2010-12-01; Completion date: 2011-06-01
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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:
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.

Arms: arm 1: Participants will receive JNJ-41443532 250 mg in morning and evening for 28 days. arm 2: Participants will receive JNJ-41443532 1000 mg (4 X 250 mg) in morning and evening for 28 days. arm 3: Participants will receive pioglitazone 30 mg in morning for 28 days. arm 4: Participants will receive matching placebo for JNJ-41443532 and pioglitazone for 28 days.
Interventions: intervention 1: JNJ-41443532 intervention 2: Pioglitazone 30 mg intervention 3: Placebo
Intervention descriptions: intervention 1: 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 2: Participants will receive tablet pioglitazone 30 mg orally in morning for 28 days. intervention 3: Participants will receive matching placebo tablets of JNJ-41443532 and/or matching placebo tablets of pioglitazone orally as per the assigned arms.

Protocol documents: