Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-41443532 · 3 trials · 2 indications
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. |
| 001 | EXPERIMENTAL | JNJ-41443532 250mg tablet once daily for 1 day |
| 002 | PLACEBO_COMPARATOR | Placebo Matching placebo |
| 003 | EXPERIMENTAL | JNJ-41443532 250mg tablet once daily |
| 004 | EXPERIMENTAL | JNJ-41443532 500mg once daily (with 250mg tablets) |
| 005 | EXPERIMENTAL | JNJ-41443532 1000mg once daily (with 250mg tablets) |
| 006 | EXPERIMENTAL | JNJ-41443532 1500mg once daily (with 250mg tablets) |
| 007 | PLACEBO_COMPARATOR | Placebo Matching placebo |
| 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 also been evaluated in healthy volunteers for pharmacokinetic studies. The drug is in clinical development by Johnson & Johnson and is not yet approved.
JNJ-41443532 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is an investigational small molecule in Phase 2 clinical development for Type 2 Diabetes Mellitus.
JNJ-41443532 is in Phase 2 clinical development. It has completed two Phase 1 trials in healthy volunteers and one Phase 2 trial in patients with Type 2 Diabetes Mellitus. The drug remains investigational and is not FDA approved.
JNJ-41443532 has completed three clinical trials. NCT01105780 was a Phase 1 pharmacokinetic study in healthy adults in the United States. NCT01106469 was a Phase 1 ascending dose study in healthy males in Belgium. NCT01230749 was a Phase 2 study in patients with Type 2 Diabetes Mellitus.
No alternative names for JNJ-41443532 have been disclosed. The drug is identified solely by its compound number in clinical trial registries and is not known to be marketed under any other name.