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Completed

NCT Number: NCT03760068

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Endocrinology Associates Montgomery, Montgomery, Alabama, United States

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About this study

This is a multicenter, open-label, randomized, parallel-group phase 3 study in subjects with T1DM comparing the safety and efficacy of MYL-1601D with NovoLog®.

After up to 3-week screening period, all subjects will be titrated on NovoLog® during a 4-week run-in period, and will be shifted from their current basal insulin to study insulin Lantus®. After run-in period, subjects will be randomized; one group will receive MYL-1601D, while the other group will receive NovoLog® for 24 weeks. A follow-up visit, via telephone call, will be scheduled 4 weeks after last dose of MYL-1601D.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written and signed informed consent.
  • Clinical diagnosis of type 1 diabetes mellitus for at least 6 months prior to screening.
  • Subject is able and willing to comply with the requirements of the study protocol.

Exclusion criteria

  • History or presence of a medical condition or disease that in the Investigator's opinion would place the subject at an unacceptable risk from study participation.
  • History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the study, OR history of significant allergic drug reactions.
  • Any clinically significant abnormality in electrocardiogram or safety laboratory tests.
  • Any elective surgery requiring hospitalization planned during the study period.
  • History of a significant medical condition, such as unstable angina, myocardial infarction, stroke or transient ischemic attack in the 6 months before screening.
  • Subjects with major depressive illness in the last 3 years.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Treatment and study plan

MYL-1601D Product

Drug

(100 U/mL)

FlexPen NovoLog®

Drug

(100 U/mL)

Primary outcomes

  1. Treatment Emergent Antibody Response (TEAR)

    Time frame: Baseline to week 24

    The number of subjects who were TEAR positive.

    TEAR is defined as either one of the following:

    • Subjects who are Anti-Drug Antibody (ADA) negative at baseline and become positive at any timepoint post baseline
    • Subjects who are ADA positive at baseline and demonstrate 4-fold increase in titer values at any timepoint post baseline visit.

Secondary outcomes

  1. Change in HbA1c From Baseline

    Time frame: Baseline to week 24

    Mean (SD) change from baseline HbA1c at Week 24.

  2. Change in Fasting Plasma Glucose From Baseline

    Time frame: Baseline to week 24

    Mean (SD) change from baseline plasma glucose at Week 24.

  3. Change in Prandial Insulin Dose From Baseline

    Time frame: Baseline to week 24

    Mean (SD) change from baseline daily mealtime insulin dose at Week 24.

  4. Change in Basal Insulin Dose From Baseline

    Time frame: Baseline to week 24

    Mean (SD) change from baseline total daily insulin dose at Week 24.

  5. Change in Total Daily Insulin Dose From Baseline

    Time frame: Baseline to week 24

    Mean (SD) change from baseline total daily insulin dose at Week 24

  6. Change in 7-point Self-monitored Blood Glucose (SMBG) Profile From Baseline

    Time frame: Baseline to week 24

    Mean (SD) change in 7-point SMBG profile from baseline to Week 24

Sponsors and collaborators

Lead sponsor

Mylan Inc.

Industry

Collaborators

  • Mylan GmbH

Registry information

Official study title

A Randomized, Multicenter, Open-Label, Parallel-Group Clinical Study Comparing the Safety and Efficacy of MYL-1601D With NovoLog® in Type 1 Diabetes Mellitus Patients

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Nov 30, 2018
Registry last updated
Feb 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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