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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.

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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

FieldValue
Enrollment Target 814 participants
Start Date 2014-11-21
Est. Completion 2017-07-24
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.