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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01869959 | A Study of LY2405319 in Participants With Type 2 Diabetes | PHASE1 | COMPLETED | 47 | — | — | Apr 1, 2009 | Dec 1, 2009 | Mar 20, 2017 | 7 | United States |
The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. SAEs were classified using the Medical Dictionary for Regulatory Activities (MedDRA) 11.0. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received placebo-matching LY2405319 injected subcutaneously (SC) once daily for 28 days. |
| 3 mg LY2405319 | EXPERIMENTAL | Participants received 3 milligrams (mg) LY2405319 injected SC once daily for 28 days. |
| 10 mg LY2405319 | EXPERIMENTAL | Participants received 10 mg LY2405319 injected SC once daily for 28 days. |
| 20 mg LY2405319 | EXPERIMENTAL | Participants received 20 mg LY2405319 injected SC once daily for 28 days. |
| Name | Type | Description |
|---|---|---|
| LY2405319 | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
Inclusion Criteria: * Have a diagnosis of T2DM. * Are on diet and exercise or diet, exercise, and metformin (stable dose of at least 1000 mg/day for at least 60 days) regimen. * Have a glycosylated hemoglobin A1c (HbA1c) value of 7.0% to 10.0%, inclusive, or are on metformin and an additional oral ...