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NCT02561078 · ClinicalTrials.gov registry record · Phase 3
An Administration Method Study of Human Regular U-500 Insulin (LY041001) in Participants With Type 2 Diabetes Mellitus
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 420
- Enrollment target
NCT02561078: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT02561078 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 420 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02561078, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 420 participants
- Enrollment target
Study Summary
The main purpose of this study is to evaluate the efficacy and safety of the study drug known as human regular U-500 insulin (U-500R) administered by continuous subcutaneous insulin infusion (CSII) versus multiple daily injections (MDI) in participants with type 2 diabetes mellitus.
Primary Outcome
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline of response, glucagon-like peptide-1 (GLP-1) or sodium-glucose cotransporter 2 (SGLT2) use, U-500R at entry, treatment, time and treatment by time interaction.
Interventions
- DRUG Human regular U-500 insulin (CSII)
- DRUG Human regular U-500 insulin (MDI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2015-10-20 |
| Est. Completion | 2017-05-09 |
| Phase | Phase 3 |
What the finished NCT02561078 record still lists
NCT02561078 is an interventional study that assigns participants to a tested intervention. The registered 420 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 (46% lower).
The record links to 0 conditions, and to 2 interventions - of which Human regular U-500 insulin (CSII) is the first listed.
NCT02561078 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02561078 about?
NCT02561078 is a clinical study titled "An Administration Method Study of Human Regular U-500 Insulin (LY041001) in Participants With Type 2 Diabetes Mellitus". The main purpose of this study is to evaluate the efficacy and safety of the study drug known as human regular U-500 insulin (U-500R) administered by continuous subcutaneous insulin infusion (CSII) versus multiple daily injections (MDI) in participants with type 2 diabetes mellitus.
What is the current status of trial NCT02561078?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 420 participants. The study started on 2015-10-20. Estimated completion is 2017-05-09.
What interventions are being tested in trial NCT02561078?
The interventions under investigation include: Human regular U-500 insulin (CSII) (DRUG), Human regular U-500 insulin (MDI) (DRUG).
Who is sponsoring clinical trial NCT02561078?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02561078's enrollment target sits among peer trials
420 891st of 2000 higher than 1,102 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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