Mylan Insulin Aspart Study

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03760068

Enrollment

478

Registered

2018-11-30

Start date

2018-11-07

Completion date

2020-01-17

Last updated

2022-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

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.

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.

Interventions

DRUGMYL-1601D Product

(100 U/mL)

DRUGFlexPen NovoLog®

(100 U/mL)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Treatment Emergent Antibody Response (TEAR)	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

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

Countries

United States

Participant flow

Participants by arm

Arm	Count
MYL-1601D Product (100 U/mL) MYL-1601D (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge. Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.	238
FlexPen NovoLog® (100 U/mL) FlexPen NovoLog® (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge. Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.	240
Total	478

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Administrative Decision by Sponsor	0	2
Overall Study	Adverse Event	1	2
Overall Study	Lost to Follow-up	4	9
Overall Study	Physician Decision	1	2
Overall Study	Subject Moved Out of State	1	0
Overall Study	Withdrawal by Subject	7	8

Baseline characteristics

Characteristic	MYL-1601D Product (100 U/mL)	FlexPen NovoLog® (100 U/mL)	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	238 Participants	240 Participants	478 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Asian	6 Participants	9 Participants	15 Participants
Race (NIH/OMB) Black or African American	15 Participants	11 Participants	26 Participants
Race (NIH/OMB) More than one race	3 Participants	8 Participants	11 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants	2 Participants	5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	210 Participants	210 Participants	420 Participants
Screening Body Mass Index	27.56 kg/m^2 STANDARD_DEVIATION 4.221	27.00 kg/m^2 STANDARD_DEVIATION 4.191	27.28 kg/m^2 STANDARD_DEVIATION 4.211
Sex: Female, Male Female	109 Participants	108 Participants	217 Participants
Sex: Female, Male Male	129 Participants	132 Participants	261 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 238	1 / 240
other Total, other adverse events	92 / 238	99 / 240
serious Total, serious adverse events	22 / 238	15 / 240

Outcome results

Primary

Treatment Emergent Antibody Response (TEAR)

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.