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NCT02588950 · ClinicalTrials.gov registry record · Phase 1
A Study of U-500 Insulin (LY041001) in Participants With Type 2 Diabetes
A Phase 1 study, sponsored by Eli Lilly and Company.
- Terminated
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT02588950: Clinical Trial Phase 1 study, sponsored by Eli Lilly and Company.
NCT02588950 is a Phase 1 study that was terminated before completion, run by Eli Lilly and Company. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02588950, a Phase 1 study, was terminated before completion, sponsored by Eli Lilly and Company.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
The purpose of this two-part study is to measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. In Part A, each participant will receive two treatments, a single dose and a single dose with continuous infusion of U-500R insulin, both administered just under the skin. Participants who complete Part A will continue into Part B where they will be assigned to 1 of 2 treatments with U-500R insulin, injected either twice or three times daily under the skin for 5-10 days. This study can last from 7-14 weeks including initial screening and follow up.
Primary Outcome
Part A: Pharmacokinetics (PK): Time to Maximum Drug Concentration (Tmax) of U-500R.
Interventions
- DRUG U-500R
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2016-01-12 |
| Est. Completion | 2017-05-25 |
| Phase | Phase 1 |
Why NCT02588950 stopped before completion
NCT02588950 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which U-500R is the first listed.
NCT02588950 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02588950 about?
NCT02588950 is a clinical study titled "A Study of U-500 Insulin (LY041001) in Participants With Type 2 Diabetes". The purpose of this two-part study is to measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. In Part A, each participant will receive two treatments, a single dose and a single dose with continuous infusion of U-500R insulin, both administer...
What is the current status of trial NCT02588950?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2016-01-12. Estimated completion is 2017-05-25.
What interventions are being tested in trial NCT02588950?
The interventions under investigation include: U-500R (DRUG).
Who is sponsoring clinical trial NCT02588950?
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 NCT02588950's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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