Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-41443532 · 1 trial · 1 indication
Difference is calculated as the change in 24-hour WAG in Least Square Mean (LSM) from baseline to Day 28 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change. 24-hour WAG is defined as the area under the plasma glucose concentration time curve over 0 to 24 hours, divided by 24.
| Arm | Type | Description |
|---|---|---|
| JNJ-41443532 250 mg | EXPERIMENTAL | Participants will receive JNJ-41443532 250 mg in morning and evening for 28 days. |
| JNJ-41443532 1000 mg | EXPERIMENTAL | Participants will receive JNJ-41443532 1000 mg (4 X 250 mg) in morning and evening for 28 days. |
| Pioglitazone | ACTIVE_COMPARATOR | Participants will receive pioglitazone 30 mg in morning for 28 days. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo for JNJ-41443532 and pioglitazone for 28 days. |
| Name | Type | Description |
|---|---|---|
| JNJ-41443532 | 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. |
| Pioglitazone 30 mg | DRUG | Participants will receive tablet pioglitazone 30 mg orally in morning for 28 days. |
| Placebo | DRUG | Participants will receive matching placebo tablets of JNJ-41443532 and/or matching placebo tablets of pioglitazone orally as per the assigned arms. |
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 ...
JNJ-41443532 is an investigational small molecule being studied for the treatment of type 2 diabetes mellitus. It has been evaluated in a Phase 2 clinical trial in adults with the condition. It is not an approved therapy and remains in clinical development.
JNJ-41443532 targets CCR2, a chemokine receptor. It acts as a CCR2 antagonist, meaning it is designed to block signaling through that receptor. This mechanism distinguishes it from therapies that act directly on glucose handling or insulin secretion.
JNJ-41443532 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The compound is an oral small molecule that the company has advanced into mid-stage clinical testing for type 2 diabetes.
JNJ-41443532 has completed a Phase 2 clinical trial and is not approved by the FDA. It remains an investigational drug in clinical development. No active trials of JNJ-41443532 are currently listed.
JNJ-41443532 has been studied in one clinical trial, NCT01230749, titled A Study of Multiple Oral Doses of JNJ-41443532 in Patients With Type 2 Diabetes Mellitus. That Phase 2 trial was completed and enrolled 89 participants.
The Phase 2 trial NCT01230749 was a randomized, double-blind, placebo-controlled study of multiple oral doses of JNJ-41443532 in patients with type 2 diabetes mellitus. It enrolled 89 participants aged 25 years and older and has been completed.