Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Albiglutide weekly injection
Albiglutide weekly · 2 trials · 2 indications
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Based on analysis of covariance (ANCOVA): Change at Week 24 = treatment (placebo, albiglutide 30 mg, albiglutide 50 mg) + Baseline HbA1c + prior diabetes therapy + age category (\<65 years versus ≥65 years). Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c carried forward for the analysis unless the value is past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group and not included in the primary endpoint analysis model. Descriptive summary statistics are provided as a separate outcome measure.
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c value carried forward for the summary, unless the value was past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group; descriptive statistics comparing albiglutide and liraglutide were exploratory endpoints.
Participants (parts) had a balanced diet consistent with dietitian's advice and made no major changes in exercise regimens. Evening before the MMTT, participants had a full meal then fasted from 9 post meridiem (pm) until MMTT was completed. Water, black coffee or tea without sugar or artificial sweeteners was allowed. Plasma glucose was measured prior to the finger-stick test and MMTT was performed only if in range \> 3.9 millimoles per liter (mmol/L) \[70 mg/deciliter (dL)\] and \<= 11.1 mmol/L (200 mg/dL). Baseline was defined as the last non-missing value with assessment date on or before the 1st day of study medication. Change from Baseline was calculated by subtracting Baseline value from Week 52 value. Intent-to-treat (ITT) Population comprised of all randomly assigned participants who received at least 1 dose of study medication with at least 1 post-Baseline assessment of the primary endpoint.
| Arm | Type | Description |
|---|---|---|
| Albiglutide 30 mg weekly | EXPERIMENTAL | Subjects will be randomly assigned to double blind albiglutide 30 mg weekly treatment for 52 weeks |
| Albiglutide 50 mg weekly | EXPERIMENTAL | Subjects will be randomly assigned to double blind albiglutide 50 mg weekly until Week 52 |
| Placebo | PLACEBO_COMPARATOR | Subjects will be randomly assigned to double blind matching albiglutide placebo administered weekly. Subjects will then cross-over to double-blind treatment with albiglutide 30 mg weekly at Week 24 until Week 52 |
| Liraglutide 0.9 mg daily | ACTIVE_COMPARATOR | Subjects will be randomly assigned to open-label liraglutide for 52 weeks |
| Albiglutide | EXPERIMENTAL | Approximately 51 subjects will be assigned to albiglutide 30 mg weekly (with treatment-masked increase to 50 mg weekly at Week 6) + background insulin. The starting dose of albiglutide will be 30 mg once weekly and will be increased at Week 6 to 50 mg, once weekly, if the 30-mg weekly dose is tolerated. |
| Name | Type | Description |
|---|---|---|
| Albiglutide 30 mg weekly | DRUG | Albiglutide will be available as a pen injector that delivers 30mg of albiglutide |
| Albiglutide 50 mg weekly | DRUG | Albiglutide will be available as a pen injector that delivers 50mg of albiglutide |
| Placebo | DRUG | Albiglutide matching placebo will be available as a pen injector |
| Liraglutide 0.9 mg daily | DRUG | Liraglutide will be available as prefilled multidose pens that can deliver 0.9 mg dose |
| Albiglutide weekly injection | BIOLOGICAL | Albiglutide will be provided as a fixed-dose, fully disposable pen injector system having a prefilled dual chamber glass cartridge. To be self-administered as a subcutaneous (SC) injection in the abdomen, thigh or upper arm region. The pen will deliver either 30 mg of albiglutide, 50 mg of albiglutide in a 0.5-mL injection volume. It may be administered at any time of day without regard to meals. It will be administered once a week on the same day each week |
| Placebo weekly injection | BIOLOGICAL | Placebo provided as a fixed-dose, fully disposable pen injector system having a prefilled dual chamber glass cartridge. To be self-administered as a SC injection in the abdomen, thigh or upper arm region. It may be administered at any time of day, once a week on the same day each week, without regard to meals. |
| Insulin | BIOLOGICAL | Commercially available basal/bolus insulin regimen, self administered by the subject, in accordance to the prescription of the physician and as per the package insert |
Inclusion Criteria: * Subjects with diagnosis of Type 2 Diabetes Mellitus, treated with diet and exercise or a stable dose of 1 OAD at screening * Body mass index (BMI) 17 to 40 kg/ m\^2 inclusive * Subjects who are OAD naïve, HbA1c between 7.0% and 10.0% at Screening and at Visit 2; for subjects w...
Albiglutide weekly is being studied for the treatment of type 1 and type 2 diabetes mellitus. It is a once-weekly injectable therapy developed by GSK plc. The clinical program has evaluated it in insulin-treated patients with new-onset type 1 diabetes and in Japanese patients with type 2 diabetes.
Albiglutide weekly is a monoclonal antibody that acts as an agonist at GLP1R, the glucagon-like peptide-1 receptor. By activating this receptor, it mimics the action of the endogenous incretin hormone GLP-1, which supports glucose-dependent insulin secretion and glucose regulation in patients with diabetes.
Albiglutide weekly is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the clinical studies of the asset, including the phase 2 trial in type 1 diabetes and the phase 3 monotherapy study in Japanese patients with type 2 diabetes.
Albiglutide weekly is an investigational agent that has been studied in phase 2 and phase 3 clinical trials. It is not described as approved. The development program includes one completed phase 2 study in type 1 diabetes and one completed phase 3 study in type 2 diabetes.
Albiglutide weekly has been evaluated in two completed trials. NCT02284009 was a phase 2 study comparing albiglutide with placebo in insulin-treated subjects with new-onset type 1 diabetes across five European countries. NCT01733758 was a phase 3 monotherapy study of two dose levels in Japanese subjects with type 2 diabetes.