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NCT03760068 · ClinicalTrials.gov registry record · Phase 3

Mylan Insulin Aspart Study

A Phase 3 study of Diabetes Mellitus, Type 1, sponsored by Mylan.

Completed
Registry status
Phase 3
Development phase
478
Enrollment target
20
Study locations

NCT03760068 is a Phase 3 study of Diabetes Mellitus, Type 1 that has completed, run by Mylan. The registered enrollment target is 478 participants, below the 1,262-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 4 states.

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The verdict

NCT03760068, a Phase 3 study of Diabetes Mellitus, Type 1, has completed, sponsored by Mylan.

COMPLETED
Registry status
Phase 3
Development phase
478 participants
Enrollment target
20
Study locations

Study Summary

The aim of this phase III trial is to demonstrate the equivalence in the safety and efficacy profile between MYL-1601D and NovoLog® in patients with T1DM.

Conditions Studied

Interventions

  • DRUG MYL-1601D Product
  • DRUG FlexPen NovoLog®

Study Locations (20)

California

  • John Muir Physician Network - Concord
  • Valley Research - Fresno
  • Marin Endocrine Care & Research, Inc. - Greenbrae
  • Diabetes/Lipid Management and Research Center - Huntington Beach
  • Diabetes And Endocrine Associates - La Mesa
  • Long Beach Center For Clinical Research - Long Beach
  • Office of Richard S. Cherlin, M.D - Los Gatos
  • The Rose Salter Medical Research Foundation - Newport Beach
  • Providence Clinical Research - North Hollywood
  • California Medical Research Associates Inc - Northridge
  • Pacific Reserach Partners - Oakland
  • Palmtree Clinical Research, Inc. - Palm Springs
  • Western Univ of Health Science - Pomona
  • Mills-Peninsula Health Services Diabetes Research Institute - San Mateo
  • NorCal Endocrinology and Internal Medicine - San Ramon
  • Sansum Diabetes Research Institute - Santa Barbara

Arizona

  • Phoenician Centers for Research - Phoenix
  • Precision Trials - Phoenix

Alabama

  • Endocrinology Associates Montgomery - Montgomery

Arkansas

  • Medical Investigations Inc. - Little Rock

Trial Details

FieldValue
Enrollment Target 478 participants
Start Date 2018-11-07
Est. Completion 2020-01-17
Phase Phase 3

Sponsor

Mylan

22 total trials

What the Registry Record Tells You About NCT03760068

The ClinicalTrials.gov registry entry for NCT03760068 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 478 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,262-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (62% lower). The listed sponsor is Mylan, which has 22 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 2 interventions - of which MYL-1601D Product is the first listed.

NCT03760068 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Arizona, Alabama.

Frequently Asked Questions

What is clinical trial NCT03760068 about?

NCT03760068 is a clinical study titled "Mylan Insulin Aspart Study". The aim of this phase III trial is to demonstrate the equivalence in the safety and efficacy profile between MYL-1601D and NovoLog® in patients with T1DM.

What is the current status of trial NCT03760068?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 478 participants. The study started on 2018-11-07. Estimated completion is 2020-01-17.

What conditions does trial NCT03760068 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Type 1.

What interventions are being tested in trial NCT03760068?

The interventions under investigation include: MYL-1601D Product (DRUG), FlexPen NovoLog® (DRUG).

Who is sponsoring clinical trial NCT03760068?

This trial is sponsored by Mylan, which has 22 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03760068 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.