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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 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 814 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02229227
The ClinicalTrials.gov registry entry for NCT02229227 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 814 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Albiglutide is the first listed.
NCT02229227 reports 0 study locations.
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.
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