Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK1362885 · 2 trials · 1 indication
| 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...
GSK1362885 is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied for its safety, tolerability, pharmacokinetics, and pharmacodynamics in clinical trials.
GSK1362885 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting Phase 1 clinical trials to evaluate the drug's safety and tolerability in healthy subjects and in patients with Type 2 Diabetes Mellitus.
GSK1362885 is in Phase 1 clinical development. Two Phase 1 trials have been completed, involving a total of 65 participants. The drug is investigational and has not received regulatory approval. It is being studied for the treatment of Type 2 Diabetes Mellitus.
GSK1362885 has been studied in two completed Phase 1 clinical trials. NCT00823940 evaluated safety and tolerability in healthy subjects with 42 participants. NCT01013766 evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics in Type 2 diabetics with 23 participants. Both trials were conducted in the United States.
GSK1362885 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Type 2 Diabetes Mellitus. The completed trials have evaluated its safety and tolerability, but the drug has not yet progressed through the later phases required for regulatory approval.