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NCT01654380 · ClinicalTrials.gov registry record · Phase 1
A Study of LY2605541 Versus Insulin Glargine on Blood Sugar
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT01654380: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT01654380 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01654380, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
LY2605541 is an investigational drug being developed for the treatment of diabetes mellitus. This study is designed to understand how the body handles the investigational drug, what effect this investigational drug has on the body, and how much should be given. This study will also measure how much of the investigational drug gets into the blood stream and how long it takes the body to get rid of it. The study has 2 parts: Part A will be conducted in healthy participants. Part B will be conducted in participants with type 1 diabetes mellitus (T1DM). This study will take approximately 10-14 days spread over 6-20 weeks, not including screening. Screening will be performed within 30 days of the start of the study.
Primary Outcome
The percent suppression from baseline in endogenous glucose production (EGP) is presented. Percent EGP change from baseline was calculated by (1-\[last 2 hours of EGP/basal EGP\])\*100. The duration of the clamp procedure was 10 hours for the LY2605541 74.1 mU/min dose in Part B. The duration of the clamp procedures performed at the 15.3 mU/min LY2605541 dose and both of the insulin glargine doses was 8 hours.
Interventions
- DRUG LY2605541
- OTHER Insulin glargine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2012-07 |
| Est. Completion | 2013-10 |
| Phase | Phase 1 |
What the finished NCT01654380 record still lists
NCT01654380 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which LY2605541 is the first listed.
NCT01654380 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01654380 about?
NCT01654380 is a clinical study titled "A Study of LY2605541 Versus Insulin Glargine on Blood Sugar". LY2605541 is an investigational drug being developed for the treatment of diabetes mellitus. This study is designed to understand how the body handles the investigational drug, what effect this investigational drug has on the body, and how much should be given. This study will also measure how much ...
What is the current status of trial NCT01654380?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2012-07. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01654380?
The interventions under investigation include: LY2605541 (DRUG), Insulin glargine (OTHER).
Who is sponsoring clinical trial NCT01654380?
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 NCT01654380's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 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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