Mylan Insulin Aspart Study



Status:Recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 65
Updated:12/2/2018
Start Date:November 1, 2018
End Date:January 21, 2020
Contact:Keri Vaughan
Email:keri.vaughan@mylan.com
Phone:+1 (267) 980-5015

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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

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.


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
We found this trial at
1
site
7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
Principal Investigator: Douglas Denham, DO
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mi
from
San Antonio, TX
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