Mylan Insulin Aspart Study

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 1

In brief

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.

Key facts

Study ID

NCT03760068

Run by

Mylan Inc.

People needed

478

Starts

2018-11-07

Expected to finish

2020-01-17

Last updated by the study team

2022-02-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Phoenician Centers for Research — Phoenix, Arizona, United States
• Precision Trials — Phoenix, Arizona, United States
• Medical Investigations Inc. — Little Rock, Arkansas, United States
• John Muir Physician Network — Concord, California, United States
• Valley Research — Fresno, California, United States
• Marin Endocrine Care & Research, Inc. — Greenbrae, California, United States
• Diabetes/Lipid Management and Research Center — Huntington Beach, California, United States
• Diabetes And Endocrine Associates — La Mesa, California, United States
• Long Beach Center For Clinical Research — Long Beach, California, United States
• Office of Richard S. Cherlin, M.D — Los Gatos, California, United States
• The Rose Salter Medical Research Foundation — Newport Beach, California, United States
• Providence Clinical Research — North Hollywood, California, United States
• California Medical Research Associates Inc — Northridge, California, United States
• Pacific Reserach Partners — Oakland, California, United States
• Palmtree Clinical Research, Inc. — Palm Springs, California, United States
• Western Univ of Health Science — Pomona, California, United States
• Mills-Peninsula Health Services Diabetes Research Institute — San Mateo, California, United States
• NorCal Endocrinology and Internal Medicine — San Ramon, California, United States
• Sansum Diabetes Research Institute — Santa Barbara, California, United States
• Coastal Biomedical Research, Inc. — Santa Monica, California, United States
• The Metabolic Institute Of America (Mioa Inc) — Tarzana, California, United States
• Diabetes Research Center — Tustin, California, United States
• Dr.Ronald H. Chochinov MD,Office Of — Ventura, California, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• Endocrinology Associates Montgomery — Montgomery, Alabama, United States

Full record on ClinicalTrials.gov

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