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Mylan Insulin Aspart Study
NCT03760068 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG MYL-1601D Product
- DRUG FlexPen NovoLog®
Study Locations (20)
California
- John Muir Physician Network — Concord
- Valley Research — Fresno
- Marin Endocrine Care & Research, Inc. — Greenbrae
- Diabetes/Lipid Management and Research Center — Huntington Beach
- Diabetes And Endocrine Associates — La Mesa
- Long Beach Center For Clinical Research — Long Beach
- Office of Richard S. Cherlin, M.D — Los Gatos
- The Rose Salter Medical Research Foundation — Newport Beach
- Providence Clinical Research — North Hollywood
- California Medical Research Associates Inc — Northridge
- Pacific Reserach Partners — Oakland
- Palmtree Clinical Research, Inc. — Palm Springs
- Western Univ of Health Science — Pomona
- Mills-Peninsula Health Services Diabetes Research Institute — San Mateo
- NorCal Endocrinology and Internal Medicine — San Ramon
- Sansum Diabetes Research Institute — Santa Barbara
Arizona
- Phoenician Centers for Research — Phoenix
- Precision Trials — Phoenix
Alabama
- Endocrinology Associates Montgomery — Montgomery
Arkansas
- Medical Investigations Inc. — Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 478 participants |
| Start Date | 2018-11-07 |
| Est. Completion | 2020-01-17 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03760068
The ClinicalTrials.gov registry entry for NCT03760068 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 478 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 2 interventions — of which MYL-1601D Product is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03760068 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Arizona, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03760068 about?
NCT03760068 is a clinical study titled "Mylan Insulin Aspart Study". 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.
What is the current status of trial NCT03760068?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 478 participants. The study started on 2018-11-07. Estimated completion is 2020-01-17.
What conditions does trial NCT03760068 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03760068?
The interventions under investigation include: MYL-1601D Product (DRUG), FlexPen NovoLog® (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03760068?
This trial is sponsored by Mylan, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03760068 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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