Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00871507 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (Explores What the Body Does to the Drug), and Pharmacodynamics (Explores What a Drug Does to the Body) of JNJ-38431055 in Volunteers With Type 2 Diabetes Mellitus | PHASE1 | COMPLETED | 25 | — | — | Apr 1, 2009 | Jul 1, 2009 | May 22, 2014 | 2 | United States |
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | - |
| 002 | EXPERIMENTAL | - |
| 003 | PLACEBO_COMPARATOR | - |
| 004 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| JNJ-38431055 Dose 1 | DRUG | Liquid suspension/solution of JNJ-38431055 administered as a single dose |
| Sitagliptin 100 mg | DRUG | Capsule containing 100 mg of sitagliptin administered as a single dose. |
| Placebo | DRUG | Placebo suspension/solution and Placebo capsule administered as single doses |
| JNJ-38431055 Dose 2 | DRUG | Liquid suspension/solution of JNJ-38431055 administered as a single dose |
Inclusion Criteria: * Males or postmenopausal or surgically sterilized females, who have type 2 diabetes mellitus * Medically stable on the basis of physical examination, medical history, laboratory safety test results, vital signs and ECG performed at Screening * Body Mass Index (BMI) between 22 a...