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NCT02683746 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 308
- Enrollment target
NCT02683746: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT02683746 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 308 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02683746, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 308 participants
- Enrollment target
Study 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.
Primary Outcome
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 sche
Interventions
- DRUG Lyophilized albiglutide DCC pen injector
- DRUG Lyophilized albiglutide DCC pen injector matching placebo
- DRUG Albiglutide liquid auto-injector
- DRUG Albiglutide liquid auto-injector matching placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 308 participants |
| Start Date | 2016-03-16 |
| Est. Completion | 2017-05-15 |
| Phase | Phase 3 |
What the finished NCT02683746 record still lists
NCT02683746 is an interventional study that assigns participants to a tested intervention. The registered 308 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 4 interventions - of which Lyophilized albiglutide DCC pen injector is the first listed.
NCT02683746 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02683746 about?
NCT02683746 is a clinical study titled "Safety and Efficacy Study of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus". 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 speci...
What is the current status of trial NCT02683746?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 308 participants. The study started on 2016-03-16. Estimated completion is 2017-05-15.
What interventions are being tested in trial NCT02683746?
The interventions under investigation include: Lyophilized albiglutide DCC pen injector (DRUG), Lyophilized albiglutide DCC pen injector matching placebo (DRUG), Albiglutide liquid auto-injector (DRUG), Albiglutide liquid auto-injector matching placebo (DRUG).
Who is sponsoring clinical trial NCT02683746?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02683746's enrollment target sits among peer trials
308 1112th of 2000 higher than 886 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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