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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00354536 | In-patient Study With GSK716155 In Patients With Type 2 Diabetes Mellitus | PHASE2 | COMPLETED | 60 | — | — | Feb 1, 2006 | Sep 1, 2006 | Oct 26, 2016 | 5 | United States |
| NCT00394030 | Injection Site Study In Patients With Type 2 Diabetes Mellitus (T2DM) And Healthy Volunteers | PHASE1 | COMPLETED | 63 | — | — | Oct 16, 2006 | Mar 20, 2007 | Sep 11, 2017 | 6 | United States |
| Arm | Type | Description |
|---|---|---|
| albiglutide | ACTIVE_COMPARATOR | albiglutide injection |
| albiglutide placebo | PLACEBO_COMPARATOR | placebo injection |
| Group A | EXPERIMENTAL | In Group A healthy subjects will be randomized to receive 16 milligram (mg) of GSK716155 to abdomen. |
| Group B | EXPERIMENTAL | In Group B healthy subjects will be randomized to receive 64 mg of GSK716155 to abdomen. |
| Group C | EXPERIMENTAL | In Group C Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to abdomen. |
| Group D | EXPERIMENTAL | In Group D Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to arm. |
| Group E | EXPERIMENTAL | In Group E Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to leg. |
| Group F | EXPERIMENTAL | In Group F Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to abdomen. |
| Group G | EXPERIMENTAL | In Group G Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to arm. |
| Group H | EXPERIMENTAL | In Group H Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to leg. |
| Name | Type | Description |
|---|---|---|
| GSK716155 subcutaneous injections | DRUG | albiglutide subcutaneous injection |
| placebo injection | BIOLOGICAL | placebo injection |
Inclusion criteria: * Subjects must have type 2 diabetes mellitus that has been diagnosed for at least three months. * Must be taking either (1) no medication for their diabetes or (2) taking metformin, a sulfonylurea, or metformin and a sulfonylurea. * Subjects must be willing to wash-out of these...