Mylan Insulin Glargine Study
Public ClinicalTrials.gov record NCT03376789. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Multi-center, Double-Blind, Parallel-Group Clinical Study Comparing the Efficacy and Safety of MYL-1501D Produced by Two Manufacturing Processes in Type 1 Diabetes Mellitus Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The aim of this study is to demonstrate similar efficacy and safety between MYL-1501D products produced from two manufacturing processes (Process V and Process VI) in combination with insulin lispro in patients with type 1 diabetes mellitus (T1DM).
Study identification
- NCT ID
- NCT03376789
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 219 participants
Conditions and interventions
Conditions
Interventions
- MYL-1501D product using manufacture process V Drug
- MYL-1501D product using manufacture process VI Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 29, 2017 (Actual)
- Primary completion
- Sep 25, 2018 (Actual)
- Completion
- Jan 10, 2019 (Actual)
- Last update posted
- Mar 3, 2022
2017 – 2019
United States locations
- U.S. sites
- 38
- U.S. states
- 8
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mylan Investigator Site | Fresno | California | 93720 | — |
| Mylan Investigator Site | Greenbrae | California | 94904 | — |
| Mylan Investigator Site | Huntington Beach | California | 92648 | — |
| Mylan Investigator Site | La Mesa | California | 91942 | — |
| Mylan Investigator Site | Los Gatos | California | 95032 | — |
| Mylan Investigator Site | Mission Hills | California | 91345 | — |
| Mylan Investigator Site | Montclair | California | 91763 | — |
| Mylan Investigator Site | Northridge | California | 91324 | — |
| Mylan Investigator Site | Oakland | California | 94607 | — |
| Mylan Investigator Site | Santa Monica | California | 90404 | — |
| Mylan Investigator Site | Tarzana | California | 91356 | — |
| Mylan Investigator Site | Tustin | California | 92780 | — |
| Mylan Investigator Site | Walnut Creek | California | 94598 | — |
| Mylan Investigator Site | Denver | Colorado | 80246 | — |
| Mylan Investigator Site | Bradenton | Florida | 34201 | — |
| Mylan Investigator Site | Fort Lauderdale | Florida | 33312 | — |
| Mylan Investigator Site | Fort Myers | Florida | 33912 | — |
| Mylan Investigator Site | Hialeah | Florida | 33012 | — |
| Mylan Investigator Site | Maitland | Florida | 32751 | — |
| Mylan Investigator Site | Miami | Florida | 33126 | — |
| Mylan Investigator Site | Miami | Florida | 33156 | — |
| Mylan Investigator Site | Miami | Florida | 33175 | — |
| Mylan Investigator Site | New Port Richey | Florida | 34652 | — |
| Mylan Investigator Site | Palm Harbor | Florida | 34684 | — |
| Mylan Investigator Site | Spring Hill | Florida | 34609 | — |
| Mylan Investigator Site | St. Petersburg | Florida | 33709 | — |
| Mylan Investigator Site | Tampa | Florida | 33634 | — |
| Mylan Investigator Site | West Palm Beach | Florida | 33401 | — |
| Mylan Investigator Site | Atlanta | Georgia | 30318 | — |
| Mylan Investigator Site | Columbus | Georgia | 31904 | — |
| Mylan Investigator Site | Lawrenceville | Georgia | 30045 | — |
| Mylan Investigator Site | Roswell | Georgia | 30076 | — |
| Mylan Investigator Site | Idaho Falls | Idaho | 83404 | — |
| Mylan Investigator Site | Meridian | Idaho | 83642 | — |
| Mylan Investigator Site | Springfield | Illinois | 62701 | — |
| Mylan Investigator Site | Council Bluffs | Iowa | 51501 | — |
| Mylan Investigator Site | Austin | Texas | 78731 | — |
| Mylan Investigator Site | Dallas | Texas | 75231 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03376789, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 3, 2022 · Synced Nov 3, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03376789 live on ClinicalTrials.gov.