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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00672386 | A Study of the Safety and Effectiveness of a R256918 in Patients With Type 2 Diabetes | PHASE2 | COMPLETED | 352 | — | — | Dec 1, 2007 | Sep 1, 2008 | Jul 14, 2014 | 62 | Belgium, Denmark +9 |
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | JNJ16269110 5 mg twice daily for 12 weeks |
| 002 | EXPERIMENTAL | JNJ16269110 10 mg twice daily for 12 weeks |
| 003 | EXPERIMENTAL | JNJ16269110 15 mg twice daily for 12 weeks |
| 004 | PLACEBO_COMPARATOR | Placebo twice daily for 12 weeks |
| Name | Type | Description |
|---|---|---|
| JNJ16269110 | DRUG | 5 mg twice daily for 12 weeks |
| Placebo | DRUG | twice daily for 12 weeks |
| Metformin | DRUG | Participants will continue taking metformin at the same dose and according to the same dosing regimen as before the study. |
| Dietary Counseling | OTHER | Participants will receive dietary counseling at Screening, Week 4, 8, 12, and will be instructed to remain on a calorically appropriate diet with a maximum of 30% of calories derived from fat (in accordance with local practice guidelines for the treatment of type 2 diabetes mellitus) during the entire study. |
Inclusion Criteria: * History of Type 2 Diabetes Mellitus and treated with a stable dose of metformin for at least 2 months * Women must be postmenopausal or surgically incapable of childbearing or if sexually active, be practicing an effective method of birth control * BMI between 25 and 45 kg/m2 ...