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Extension Study to Assess Safety and Efficacy of Mylan's Insulin Glargine and Lantus® in Type 1 Diabetes Mellitus (T1DM) Patients

NCT02666430 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2022-03-03

Study results available
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Summary

The aim of this extension study is to assess the safety and efficacy of Mylan's insulin glargine and Lantus® in T1DM patients.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

Mylan's insulin glargine

DRUG

Lantus®

Sponsors & Collaborators

  • Mylan GmbH

    collaborator INDUSTRY

  • Mylan Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas Blevins · Texas Diabetes & Endocrinology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
66 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-03-31
Completion
2017-07-31

Countries

  • United States
  • Canada
  • Czechia
  • Estonia
  • Germany
  • Hungary
  • Latvia
  • Slovakia

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 NCT02666430 on ClinicalTrials.gov