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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01013766 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK1362885 in Type 2 Diabetics | PHASE1 | COMPLETED | 23 | — | — | Aug 13, 2009 | Nov 20, 2009 | Jun 20, 2017 | 2 | United States |
| NCT00823940 | A Phase 1 Study to Evaluate the Safety and Tolerability of GSK1362885 in Healthy Normal Subjects | PHASE1 | COMPLETED | 42 | — | — | Jan 13, 2009 | Apr 27, 2009 | Jul 7, 2017 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| AM/PM/BID | OTHER | Subjects will receive a dose of 100mg in the AM on Day 1, followed by a dose of 100mg in the PM on Day 4, and a dose of 50mg BID on Day 6. |
| PM/AM/BID | OTHER | Subjects will receive a dose of 100mg in the PM on Day 1, followed by a dose of 100mg in the AM on Day 4, followed by 50mg BID on Day 6. |
| Cohort A1 | PLACEBO_COMPARATOR | Dose escalation: 5 - 100mg and placebo in 4 planned doses |
| Cohort A2 | PLACEBO_COMPARATOR | Dose escalation: 100-600mg and placebo in 4 planned doses |
| Cohort B1 | OTHER | Glucagon challenge test |
| Cohort B3 | ACTIVE_COMPARATOR | Glucagon challenge test + selected dose of GSK1362885 |
| Name | Type | Description |
|---|---|---|
| GSK1362885 | DRUG | 100mg in the AM, 100mg in the PM, 50mg BID |
| Glucagon | DRUG | 0.5mg IV bolus |
| Glucagon + GSK1362885 | DRUG | 0.5mg Glucagon IV bolus + selected dose of GSK1362885 |
Inclusion Criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: * A diagnosis of T2DM as determined by a responsible physician based on a medical evaluation including medical history, physical examination, and laboratory tests. Subjects may b...