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Also known as Lyophilized albiglutide DCC pen injector
Albiglutide Lyophilized 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...
Albiglutide Lyophilized DCC Pen Injector is an investigational injectable formulation of albiglutide, a GLP1R agonist developed by GSK plc for the treatment of type 2 diabetes mellitus. It is a lyophilized drug product delivered via a DCC pen injector and has been studied in a Phase 3 clinical trial.
Albiglutide Lyophilized DCC Pen Injector is being developed for the treatment of Diabetes Mellitus, Type 2. It is intended to help manage blood glucose in adults with type 2 diabetes. The formulation is a lyophilized drug product administered through a DCC pen injector.
Albiglutide Lyophilized DCC Pen Injector targets GLP1R, the glucagon-like peptide-1 receptor. It acts as a GLP1R agonist. By activating this receptor, it mimics the action of endogenous GLP-1, which is involved in glucose-dependent insulin secretion and glycemic control in type 2 diabetes.
Albiglutide Lyophilized DCC Pen Injector is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating this lyophilized formulation of albiglutide for type 2 diabetes.
Albiglutide Lyophilized DCC Pen Injector is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA. The Phase 3 trial for this formulation has been completed.
Albiglutide Lyophilized DCC Pen Injector has been evaluated in one Phase 3 clinical trial, NCT02683746, titled Safety and Efficacy Study of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus. This completed trial enrolled 308 participants in the United States and was randomized, double-blind, and controlled.
Yes, Albiglutide Lyophilized DCC Pen Injector is also known as Lyophilized albiglutide DCC pen injector. Both names refer to the same GLP1R agonist formulation developed by GSK plc for type 2 diabetes.