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Mylan Insulin Aspart Study

NCT03760068 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 478

Last updated 2022-02-25

Study results available
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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

  • Diabetes Mellitus, Type 1

Interventions

DRUG

MYL-1601D Product

(100 U/mL)

DRUG

FlexPen NovoLog®

(100 U/mL)

Sponsors & Collaborators

  • Mylan GmbH

    collaborator INDUSTRY

  • Mylan Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-07
Primary Completion
2019-12-28
Completion
2020-01-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03760068 on ClinicalTrials.gov