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NCT02229227 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine Subjects With Type 2 Diabetes Mellitus
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 814
- Enrollment target
NCT02229227: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT02229227 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 814 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02229227, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 814 participants
- Enrollment target
Study Summary
This Phase IIIb, randomized, open-label, parallel group, active control, multicenter, treat to-target study of 26 weeks' treatment duration will evaluate the efficacy and safety of once-weekly albiglutide as replacement of prandial insulin in subjects with type 2 diabetes mellitus (T2DM) failing to achieve adequate glycemic control on their current basal bolus insulin regimen (with or without metformin). Approximately 794 subjects will be randomly assigned in a 1:1 ratio to 1 of 2 treatment groups: albiglutide + insulin glargine (with insulin lispro discontinuation at Week 4) (with or without metformin) or to intensification of insulin glargine + insulin lispro (with or without metformin). The study will comprise 4 study periods : Screening (2 weeks), Standardization (4 weeks), Treatment (26 weeks), and Post treatment Follow up (4 weeks). The total duration of a subject's participation will be approximately 36 weeks.
Primary Outcome
HbA1c is glycosylated hemoglobin. It was measured at Baseline and at Week 26. The analysis was conducted using mixed-effect model with repeated measures (MMRM). The model included HbA1c change from Baseline as the dependent variable; treatment, region, age category, current metformin use, visit week, treatment-by-week interaction, and Baseline HbA1c-by-week interaction as fixed effects; Baseline HbA1c as a continuous covariate; and participant as a random effect. The Baseline value was the last
Interventions
- DRUG Albiglutide
- DRUG Insulin Glargine and Insulin Lispro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 814 participants |
| Start Date | 2014-11-21 |
| Est. Completion | 2017-07-24 |
| Phase | Phase 3 |
What the finished NCT02229227 record still lists
NCT02229227 is an interventional study that assigns participants to a tested intervention. The registered 814 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Albiglutide is the first listed.
NCT02229227 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02229227 about?
NCT02229227 is a clinical study titled "Safety and Efficacy of Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine Subjects With Type 2 Diabetes Mellitus". This Phase IIIb, randomized, open-label, parallel group, active control, multicenter, treat to-target study of 26 weeks' treatment duration will evaluate the efficacy and safety of once-weekly albiglutide as replacement of prandial insulin in subjects with type 2 diabetes mellitus (T2DM) failing to ...
What is the current status of trial NCT02229227?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 814 participants. The study started on 2014-11-21. Estimated completion is 2017-07-24.
What interventions are being tested in trial NCT02229227?
The interventions under investigation include: Albiglutide (DRUG), Insulin Glargine and Insulin Lispro (DRUG).
Who is sponsoring clinical trial NCT02229227?
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 NCT02229227's enrollment target sits among peer trials
814 407th of 2000 higher than 1,594 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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