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Lyophilized albiglutide DCC pen injector · 1 trial · 1 indication
Blood samples will be collected from participants at specific time points to evaluate HbA1c to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a mixed-effect model with repeated measures (MMRM) method. The primary analysis will include all HbA1c values collected at scheduled visits from Week 4 up to Week 26. This will include values after hyperglycemia rescue and discontinuation from investigational product. Imputation under the non-inferiority null hypothesis for missing data will be incorporated.
| Arm | Type | Description |
|---|---|---|
| Albiglutide active LAI plus Placebo lyophilized DCC PI | EXPERIMENTAL | Subjects will receive 30 milligrams (mg) of albiglutide liquid drug product via auto injector and matching placebo via lyophilized DCC pen injector for 4 weeks. The dose will then be up-titrated to 50mg albiglutide for the remaining 22 weeks of the study. The study treatment will be administered once weekly by subcutaneous injection in the abdomen, thigh, or upper arm. |
| Albiglutide lyophilized DCC PI plus Placebo LAI | EXPERIMENTAL | Subjects will receive 30mg of albiglutide lyophilized drug product via DCC pen injector and matching placebo via auto injector for 4 weeks. The dose will then be up-titrated to 50mg albiglutide for the remaining 22 weeks of the study. The study treatment will be administered once weekly by subcutaneous injection in the abdomen, thigh, or upper arm. |
| Name | Type | Description |
|---|---|---|
| Lyophilized albiglutide DCC pen injector | DRUG | A fixed-dose, fully disposable pen injector system with a prefilled dual chamber glass cartridge (DCC) containing lyophilized albiglutide (30mg or 50mg) delivering an injection volume of 0.5mL. |
| Lyophilized albiglutide DCC pen injector matching placebo | DRUG | A fixed-dose, fully disposable pen injector system with a prefilled DCC containing matching placebo delivering an injection volume of 0.5mL |
| Albiglutide liquid auto-injector | DRUG | A fixed-dose, single use, disposable auto-injector containing albiglutide liquid (30mg or 50mg) in a prefilled glass syringe. The auto-injector delivers the albiglutide liquid in an injection volume of 0.6 mL for the 30mg dose and 1.0 mL for the 50mg dose. |
| Albiglutide liquid auto-injector matching placebo | DRUG | A fixed-dose, single use, disposable auto-injector containing matching placebo in a prefilled glass syringe. The auto-injector delivers the matching placebo in an injection volume of 0.6 mL for the 30mg dose and 1.0 mL for the 50mg dose. |
Inclusion Criteria: * 18 to 80 years of age inclusive * Historical diagnosis of type 2 diabetes mellitus (T2DM) (at least 3 months), experiencing inadequate glycemic control on current regimen of diet and exercise or on a stable maximal tolerated dose of metformin, maintained for approximately 8 we...
Lyophilized albiglutide DCC pen injector is used for the treatment of Type 2 Diabetes Mellitus. It is a small molecule being developed by GSK plc for this metabolic condition. The drug is administered via a pen injector device and is currently in clinical development.
GSK plc (ticker: GSK) is developing Lyophilized albiglutide DCC pen injector. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Type 2 Diabetes Mellitus.
Lyophilized albiglutide DCC pen injector is in Phase 3 clinical development. It is an investigational drug, not yet approved by regulatory authorities. One Phase 3 trial has been completed, and the drug remains under investigation for Type 2 Diabetes Mellitus.
Lyophilized albiglutide DCC pen injector has one completed Phase 3 trial, NCT02683746, titled 'Safety and Efficacy Study of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus'. This randomized, double-blind, controlled trial enrolled 308 participants in the United States.
Lyophilized albiglutide DCC pen injector is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for Type 2 Diabetes Mellitus. The completed trial NCT02683746 evaluated its safety and efficacy, but regulatory approval has not been granted.