Clinical trial NCT01230749: A Study of Multiple Oral Doses of JNJ-41443532 in Patients With Type 2 Diabetes Mellitus
Official title: A Double-Blind, Randomized, Placebo- and Active Comparator-Controlled, 4-Week Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of JNJ-41443532 in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Diabetes Mellitus
Hyperglycemia
JNJ-41443532
Pioglitazone
Placebo
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2010-10-29
Enrollment: 89
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change From Baseline (Day -1) to Day 28 in Twenty-Four-Hour Weighted Average Glucose (24-Hour WAG)
timeFrame: From baseline (Day -1) to Day 28
Secondary outcomes:
measure: Change From Baseline to Day 28 in Fasting Plasma Glucose (FPG)
timeFrame: From baseline to Day 28
measure: Change From Baseline to Day 28 in Insulin Secretion
timeFrame: From baseline to Day 28
measure: Change From Baseline to Day 28 in Insulin Resistance
timeFrame: From baseline to Day 28
measure: Change From Baseline to Day 28 in Systemic Levels of Interleukin 6 (IL-6)
timeFrame: From baseline to Day 28
measure: Change From Baseline to Day 28 in Systemic Levels of Interleukin 18 (IL-18)
timeFrame: From baseline to Day 28
measure: Change From Baseline to Day 28 in Systemic Levels of C-Reactive Protein (CRP)
timeFrame: From baseline to Day 28
measure: Change From Baseline to Day 29 in Body Weight
timeFrame: From baseline to Day 29
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References: