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NCT02061969 · ClinicalTrials.gov registry record · Phase 4

ADA Linagliptin in Long Term Care

A Phase 4 study, sponsored by Emory University.

Completed
Registry status
Phase 4
Development phase
140
Enrollment target

NCT02061969 is a Phase 4 study that has completed, run by Emory University. The registered enrollment target is 140 participants.

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The verdict

NCT02061969, a Phase 4 study, has completed, sponsored by Emory University.

COMPLETED
Registry status
Phase 4
Development phase
140 participants
Enrollment target

Study Summary

This is a study to determine whether glycemic control, as measured by change in HbA1c and frequency of hypoglycemia, is different between treatment with linagliptin (Tradjenta®) and basal insulin in long term care residents(LTC) with Type 2 diabetes(T2D). Patients with poorly controlled diabetes (HbA1c \>7.5%) will be randomized to a 6-month intervention with linagliptin or glargine insulin (± metformin for both treatments). Our hypothesis is that treatment with linagliptin, a once daily DPP4-inhibitor, will result in similar improvement in glucose control but in a lower rate of hypoglycemia than insulin treatment in LTC residents with T2D. We will also determine differences in clinical outcome, resource utilization, and hospitalization costs between LTC residents with T2D treated with linagliptin and basal and correction insulin. We will compare differences in complications (infectious and non-infectious, neurological and cardiovascular events), emergency room visits and hospitalizations between groups during the 6 months of intervention.

Interventions

  • DRUG insulin glargine
  • DRUG linagliptin

Trial Details

FieldValue
Enrollment Target 140 participants
Start Date 2014-04-25
Est. Completion 2017-04-10
Phase Phase 4

Sponsor

Emory University

1,208 total trials

What the Registry Record Tells You About NCT02061969

The ClinicalTrials.gov registry entry for NCT02061969 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which insulin glargine is the first listed.

NCT02061969 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02061969 about?

NCT02061969 is a clinical study titled "ADA Linagliptin in Long Term Care". This is a study to determine whether glycemic control, as measured by change in HbA1c and frequency of hypoglycemia, is different between treatment with linagliptin (Tradjenta®) and basal insulin in long term care residents(LTC) with Type 2 diabetes(T2D). Patients with poorly controlled diabetes (Hb...

What is the current status of trial NCT02061969?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 140 participants. The study started on 2014-04-25. Estimated completion is 2017-04-10.

What interventions are being tested in trial NCT02061969?

The interventions under investigation include: insulin glargine (DRUG), linagliptin (DRUG).

Who is sponsoring clinical trial NCT02061969?

This trial is sponsored by Emory University, which has 1,208 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.