Mylan Insulin Aspart Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: MYL-1601D Product
* Drug: FlexPen NovoLog®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MYL-1601D Product (100 U/mL)<br> | Drug: MYL-1601D Product<br>* (100 U/mL)<br>|
| Active Comparator: FlexPen NovoLog® (100 U/mL)<br> | Drug: FlexPen NovoLog®<br>* (100 U/mL)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Emergent Antibody Response (TEAR) | 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. | Baseline to week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c From Baseline | Mean (SD) change from baseline HbA1c at Week 24. | Baseline to week 24 | 
| Change in Fasting Plasma Glucose From Baseline | Mean (SD) change from baseline plasma glucose at Week 24. | Baseline to week 24 | 
| Change in Prandial Insulin Dose From Baseline | Mean (SD) change from baseline daily mealtime insulin dose at Week 24. | Baseline to week 24 | 
| Change in Basal Insulin Dose From Baseline | Mean (SD) change from baseline total daily insulin dose at Week 24. | Baseline to week 24 | 
| Change in Total Daily Insulin Dose From Baseline | Mean (SD) change from baseline total daily insulin dose at Week 24 | Baseline to week 24 | 
| Change in 7-point Self-monitored Blood Glucose (SMBG) Profile From Baseline | Mean (SD) change in 7-point SMBG profile from baseline to Week 24 | Baseline to week 24 |