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NCT03376789 · ClinicalTrials.gov registry record · Phase 3

Mylan Insulin Glargine Study

A Phase 3 study, sponsored by Mylan.

Completed
Registry status
Phase 3
Development phase
219
Enrollment target

NCT03376789 is a Phase 3 study that has completed, run by Mylan. The registered enrollment target is 219 participants.

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The verdict

NCT03376789, a Phase 3 study, has completed, sponsored by Mylan.

COMPLETED
Registry status
Phase 3
Development phase
219 participants
Enrollment target

Study Summary

The aim of this study is to demonstrate similar efficacy and safety between MYL-1501D products produced from two manufacturing processes (Process V and Process VI) in combination with insulin lispro in patients with type 1 diabetes mellitus (T1DM).

Interventions

  • DRUG MYL-1501D product using manufacture process V
  • DRUG MYL-1501D product using manufacture process VI

Trial Details

FieldValue
Enrollment Target 219 participants
Start Date 2017-11-29
Est. Completion 2019-01-10
Phase Phase 3

Sponsor

Mylan

22 total trials

What the Registry Record Tells You About NCT03376789

The ClinicalTrials.gov registry entry for NCT03376789 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 219 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan, which has 22 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which MYL-1501D product using manufacture process V is the first listed.

NCT03376789 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03376789 about?

NCT03376789 is a clinical study titled "Mylan Insulin Glargine Study". The aim of this study is to demonstrate similar efficacy and safety between MYL-1501D products produced from two manufacturing processes (Process V and Process VI) in combination with insulin lispro in patients with type 1 diabetes mellitus (T1DM).

What is the current status of trial NCT03376789?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 219 participants. The study started on 2017-11-29. Estimated completion is 2019-01-10.

What interventions are being tested in trial NCT03376789?

The interventions under investigation include: MYL-1501D product using manufacture process V (DRUG), MYL-1501D product using manufacture process VI (DRUG).

Who is sponsoring clinical trial NCT03376789?

This trial is sponsored by Mylan, which has 22 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.