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NCT03376789 · ClinicalTrials.gov registry record · Phase 3
Mylan Insulin Glargine Study
A Phase 3 study, sponsored by Mylan.
- Completed
- Registry status
- Phase 3
- Development phase
- 219
- Enrollment target
NCT03376789: Completed Phase 3 study, sponsored by Mylan.
NCT03376789 is a Phase 3 study that has completed, run by Mylan. The registered enrollment target is 219 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03376789, a Phase 3 study, has completed, sponsored by Mylan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 219 participants
- Enrollment target
Study Summary
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).
Primary Outcome
Change in HbA1c from baseline
Interventions
- DRUG MYL-1501D product using manufacture process V
- DRUG MYL-1501D product using manufacture process VI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 219 participants |
| Start Date | 2017-11-29 |
| Est. Completion | 2019-01-10 |
| Phase | Phase 3 |
What the finished NCT03376789 record still lists
NCT03376789 is an interventional study that assigns participants to a tested intervention. The registered 219 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which MYL-1501D product using manufacture process V is the first listed.
NCT03376789 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03376789 about?
NCT03376789 is a clinical study titled "Mylan Insulin Glargine Study". 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).
What is the current status of trial NCT03376789?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 219 participants. The study started on 2017-11-29. Estimated completion is 2019-01-10.
What interventions are being tested in trial NCT03376789?
The interventions under investigation include: MYL-1501D product using manufacture process V (DRUG), MYL-1501D product using manufacture process VI (DRUG).
Who is sponsoring clinical trial NCT03376789?
This trial is sponsored by Mylan, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03376789's enrollment target sits among peer trials
219 1329th of 2000 higher than 670 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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