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Mylan Insulin Aspart Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03760068
Recruitment Status : Completed
First Posted : November 30, 2018
Results First Posted : January 27, 2021
Last Update Posted : February 25, 2022
Sponsor:
Collaborator:
Mylan GmbH
Information provided by (Responsible Party):
Viatris Inc. ( Mylan Inc. )

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: MYL-1601D Product Drug: FlexPen NovoLog® Phase 3

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 478 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : November 7, 2018
Actual Primary Completion Date : December 28, 2019
Actual Study Completion Date : January 17, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: MYL-1601D Product (100 U/mL) Drug: MYL-1601D Product
(100 U/mL)
Active Comparator: FlexPen NovoLog® (100 U/mL) Drug: FlexPen NovoLog®
(100 U/mL)


Outcome Measures
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Primary Outcome Measures :
  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:

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


Secondary Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

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

Exclusion Criteria

  1. 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.
  2. 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.
  3. Any clinically significant abnormality in electrocardiogram or safety laboratory tests.
  4. Any elective surgery requiring hospitalization planned during the study period.
  5. History of a significant medical condition, such as unstable angina, myocardial infarction, stroke or transient ischemic attack in the 6 months before screening.
  6. 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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03760068


Locations
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Sponsors and Collaborators
Mylan Inc.
Mylan GmbH
  Study Documents (Full-Text)

Documents provided by Viatris Inc. ( Mylan Inc. ):
Study Protocol  [PDF] October 14, 2019
Statistical Analysis Plan  [PDF] March 2, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mylan Inc.
ClinicalTrials.gov Identifier: NCT03760068    
Other Study ID Numbers: MYL-1601D-3001
First Posted: November 30, 2018    Key Record Dates
Results First Posted: January 27, 2021
Last Update Posted: February 25, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs