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Mylan Insulin Glargine Study

NCT03376789 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2022-03-03

Study results available
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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).

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

MYL-1501D product using manufacture process V

MYL-1501D product using manufacture process V

DRUG

MYL-1501D product using manufacture process VI

MYL-1501D product using manufacture process VI

Sponsors & Collaborators

  • Mylan GmbH

    collaborator INDUSTRY

  • Mylan Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-11-29
Primary Completion
2018-09-25
Completion
2019-01-10
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 NCT03376789 on ClinicalTrials.gov