Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 an investigational drug being studied for the treatment of Type 1 and Type 2 diabetes mellitus. It is a monoclonal antibody developed by GSK plc. Clinical trials have evaluated its efficacy and safety in patients with these conditions, including a study in Japanese subjects with Type 2 diabetes.
Albiglutide weekly is a monoclonal antibody, but its specific molecular target is not disclosed in the available information. It is being investigated for its effects on glucose control in patients with Type 1 and Type 2 diabetes mellitus, though the precise mechanism of action is not detailed.
Albiglutide weekly is developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating diabetes mellitus.
Albiglutide weekly is in Phase 2 clinical development for Type 1 diabetes mellitus. A Phase 3 trial has also been completed for Type 2 diabetes mellitus. The drug is investigational and not yet approved for any use, as it remains under clinical evaluation.
Albiglutide weekly has been studied in two completed clinical trials. NCT01733758 was a Phase 3 monotherapy study in Japanese subjects with Type 2 diabetes, enrolling 494 participants. NCT02284009 was a Phase 2 trial comparing Albiglutide to placebo in insulin-treated subjects with new-onset Type 1 diabetes, enrolling 67 participants.
Albiglutide weekly is a distinct investigational monoclonal antibody developed by GSK plc. It is not identified as being the same as any other named drug in the available information. Its unique profile is being studied specifically for its effects in Type 1 and Type 2 diabetes mellitus.