Phase 3
Completed N=308
Safety and Efficacy Study of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT02683746 ↗Enrolled (actual)
308
Serious AEs
5.2%
Results posted
May 2018
Primary outcomePrimary: Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 — -1.12; -1.18 Percentage of total hemoglobin — p=0.0002
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is a phase III, randomized, double-blind, multicenter, parallel group, repeat-dose, study of 26 weeks duration to evaluate the efficacy, safety, tolerability and pharmacodynamic response of albiglutide liquid drug product relative to the commercial lyophilized drug product. The study will specifically evaluate the potential for immunogenicity (example [e.g.] incidences of anti-drug antibodies [ADA]) and injection site reactions (ISRs).
Albiglutide is a novel analogue of glucagon-like peptide-1 (GLP-1) with a sufficiently long half-life to permit once a week injection. Currently, lyophilized albiglutide and the diluent are provided in a dual chamber cartridge (DCC), single-dose pen injector, requiring reconstitution prior to use. A liquid formulation of albiglutide will enable the commercialization of a liquid product in a single dose, ready-to-use prefilled syringe in an auto-injector.
The primary hypothesis of this study is to test that liquid drug product will provide glycemic control (as measured by HbA1c change from baseline) non-inferior to lyophilized drug product for a period of 26 weeks of treatment in subjects with T2DM.
This study will comprise of 3 study periods : screening (2 weeks), treatment (26 weeks) and for those subjects not entering the extension study a follow-up period (8 weeks). Approximately 300 subjects will be randomized in a 1:1 ratio to either Albiglutide active liquid auto-injector (LAI) plus Placebo lyophilized DCC pen injector (lyophilized DCC PI); or, Albiglutide lyophilized DCC PI plus Placebo LAI.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 |
-1.12; -1.18 | 0.0002 sig |
| SECONDARY Number of Participants With On-therapy Adverse Events (AEs) and Serious AEs (SAEs) |
101; 94; 7; 9 | — |
| SECONDARY Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC) |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Hematology Parameters of PCC |
2; 6; 5; 2; 3; 9 | — |
| SECONDARY Number of Participants With Vital Signs of PCC |
18; 16; 11; 13; 0; 0 | — |
| SECONDARY Number of Participants With Electrocardiogram (ECG) Parameters of PCC |
2; 2; 1; 0; 1; 2 | — |
| SECONDARY Number of Participants With Positive Result for Anti-albiglutide Antibody |
17; 16 | — |
| SECONDARY Number of Participants With Injection Site Reactions (ISR) |
17; 18 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 |
-2.22; -1.88 | — |
| SECONDARY Change From Baseline in HbA1c Over Time |
-0.50; -0.54; -0.96; -1.02; -1.15; -1.23 | <0.0001 sig |
| SECONDARY Change From Baseline in FPG Over Time |
-1.04; -1.29; -1.52; -1.77; -1.71; -1.70 | — |
| SECONDARY Trough Plasma Concentration of Albiglutide Over Time |
3996.9; 3927.1; 4196.6; 3929.1 | — |
Eligibility Criteria
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 weeks prior to screening.
- HbA1c >=7.0 percent (%) and =11 grams per deciliter (g/dL) (>=110 grams per liter [g/L]) for males and >=10 g/dL (>=100 g/L) for females.
- Body mass index 470 milliseconds (msec).
- ALT >2.5x upper limit of the normal range (ULN) or bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin 750 milligrams per deciliter (mg/dL) at screening.
- Hemoglobinopathy that may affect proper interpretation of HbA1c.
- Medical or psychiatric disorders that would preclude effective participation in study.
- Use of oral or systemically injected glucocorticoids within the 3 months before randomization or high likelihood of a requirement for prolonged treatment (>1 week) in the 6 months following randomization.
- Use of dipeptidyl peptidase-IV inhibitors within the 3 months before randomization.
- History of alcohol or substance abuse within one year before screening.
- Known allergy to albiglutide or any product components (including yeast and human albumin), any other glucagon-like peptide-1 (GLP-1) analogue, or other study medication's excipients OR other contraindications (per the prescribing information) for the use of potential study medications.
- A positive pre-study drug/alcohol screen.
- A positive test for human immunodeficiency virus (HIV) antibody.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Data sourced from ClinicalTrials.gov (NCT02683746). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.