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NCT02240680 · ClinicalTrials.gov registry record · Phase 4

Linagliptin as Add on to Basal Insulin in the Elderly

A Phase 4 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 4
Development phase
302
Enrollment target

NCT02240680 is a Phase 4 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 302 participants.

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The verdict

NCT02240680, a Phase 4 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 4
Development phase
302 participants
Enrollment target

Study Summary

To investigate the efficacy, safety, and tolerability of linagliptin 5 milligrams once a day compared to placebo as as add-on therapy for 24 weeks to stable basal insulin treatment in elderly patients, 60 years of age and older, with Type 2 Diabetes Mellitus and insufficient glycaemic control.Stable background therapy of metformin and/or alpha-glucosidase inhibitors is also allowed. In addition, this trial will assess if linagliptin reduces the risk of hypoglycaemia when added to background basal insulin therapy. The treatment duration of this trial (24 weeks) will enable assessment of the clinically relevant endpoint of a decrease in glycosylated Haemoglobin, a well-accepted measurement of chronic glycaemic control.

Interventions

  • DRUG placebo
  • DRUG linagliptin

Trial Details

FieldValue
Enrollment Target 302 participants
Start Date 2014-09-23
Est. Completion 2017-04-25
Phase Phase 4

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT02240680

The ClinicalTrials.gov registry entry for NCT02240680 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 302 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

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

NCT02240680 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02240680 about?

NCT02240680 is a clinical study titled "Linagliptin as Add on to Basal Insulin in the Elderly". To investigate the efficacy, safety, and tolerability of linagliptin 5 milligrams once a day compared to placebo as as add-on therapy for 24 weeks to stable basal insulin treatment in elderly patients, 60 years of age and older, with Type 2 Diabetes Mellitus and insufficient glycaemic control.Stable...

What is the current status of trial NCT02240680?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 302 participants. The study started on 2014-09-23. Estimated completion is 2017-04-25.

What interventions are being tested in trial NCT02240680?

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

Who is sponsoring clinical trial NCT02240680?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

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

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.