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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01358981 | A Study of LY2881835 in Healthy People and People With Diabetes | PHASE1 | COMPLETED | 18 | — | — | May 24, 2011 | Aug 17, 2011 | Jun 19, 2019 | 1 | Singapore |
Clinically significant adverse effects are treatment emergent adverse events (TEAEs) possibly related to study drug.
| Arm | Type | Description |
|---|---|---|
| LY2881835 | EXPERIMENTAL | One cohort of healthy participants will receive single oral doses of LY2881835 in up to 3 of the 4 periods in Part A (dose escalation: 0.5 milligram (mg), 1.5 mg, subsequent doses determined based on review of safety, tolerability, glycaemic response and available pharmacokinetic (PK) data from the first 2 dose levels). One cohort of participants with Type 2 Diabetes Mellitus (T2DM) will receive single oral doses of LY2881835 in up to 2 of the 3 periods in Part B (dose escalation: starting dose based on review of safety, tolerability, glycaemic response and available PK data from Part A). There is a washout period of at least 5 days between periods (doses). |
| placebo | PLACEBO_COMPARATOR | One cohort of healthy participants will receive a single oral dose of placebo in 1 of the 4 periods in Part A. Another cohort of participants with T2DM will receive a single oral dose of placebo in 1 of the 3 periods in Part B. There is a washout period of at least 5 days between periods (doses). |
| Name | Type | Description |
|---|---|---|
| LY2881835 | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
Inclusion Criteria: All subjects: * Are a healthy male or a healthy female who cannot become pregnant, or are patients with Type 2 Diabetes Mellitus (T2DM) who are not taking any drugs to lower blood sugar except metformin * Have a body mass index (BMI) of at least 18.5 kilograms per meter squared...