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NCT01098539 · ClinicalTrials.gov registry record · Phase 3

A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.

A Phase 3 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
507
Enrollment target

NCT01098539 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 507 participants.

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The verdict

NCT01098539, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
507 participants
Enrollment target

Study Summary

This randomized, double-blind, active-controlled study evaluates the efficacy and safety of a weekly dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.

Interventions

  • BIOLOGICAL albiglutide
  • DRUG sitagliptin

Trial Details

FieldValue
Enrollment Target 507 participants
Start Date 2010-05
Est. Completion 2012-11
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT01098539

The ClinicalTrials.gov registry entry for NCT01098539 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 507 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.

NCT01098539 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01098539 about?

NCT01098539 is a clinical study titled "A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.". This randomized, double-blind, active-controlled study evaluates the efficacy and safety of a weekly dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their curr...

What is the current status of trial NCT01098539?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 507 participants. The study started on 2010-05. Estimated completion is 2012-11.

What interventions are being tested in trial NCT01098539?

The interventions under investigation include: albiglutide (BIOLOGICAL), sitagliptin (DRUG).

Who is sponsoring clinical trial NCT01098539?

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.