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NCT03760068 · ClinicalTrials.gov registry record · Phase 3
Mylan Insulin Aspart Study
A Phase 3 study of Diabetes Mellitus, Type 1, sponsored by Mylan.
- Completed
- Registry status
- Phase 3
- Development phase
- 478
- Enrollment target
- 20
- Study locations
NCT03760068: Completed Phase 3 study of Diabetes Mellitus, Type 1, sponsored by Mylan.
NCT03760068 is a Phase 3 study of Diabetes Mellitus, Type 1 that has completed, run by Mylan. The registered enrollment target is 478 participants, below the 1,262-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03760068, a Phase 3 study of Diabetes Mellitus, Type 1, has completed, sponsored by Mylan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 478 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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.
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 |
What the finished NCT03760068 record still lists
NCT03760068 is an interventional study that assigns participants to a tested intervention. The registered 478 participants enrollment target is mid-sized for trials with a published cap, below the 1,262-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (62% lower).
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.
NCT03760068 names 20 study sites across 4 states, led by California, Arizona, Alabama.
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.
What interventions are being tested in trial NCT03760068?
The interventions under investigation include: MYL-1601D Product (DRUG), FlexPen NovoLog® (DRUG).
Who is sponsoring clinical trial NCT03760068?
This trial is sponsored by Mylan, which has 22 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 1
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03760068's enrollment target sits among peer trials
478 17th of 118 higher than 102 of 118 other Diabetes Mellitus, Type 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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