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NCT01582451 · ClinicalTrials.gov registry record · Phase 3
A Study of LY2605541 in Participants With Type 2 Diabetes Mellitus
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 466
- Enrollment target
NCT01582451: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT01582451 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 466 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01582451, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 466 participants
- Enrollment target
Study Summary
The purpose of this study is to compare LY2605541 and insulin glargine using the following measures after participants have been treated for 26 weeks: * Change in participants' overall blood sugar control * The rate of night time low blood sugar episodes * The number of participants that reach blood sugar targets without low blood sugar episodes at night * The rate of low blood sugar episodes reported over a 24-hour period
Primary Outcome
HbA1c is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for stratification factors (country, baseline low-density lipoprotein cholesterol \[LDL-C, \<100 milligrams per deciliter (mg/dL) and ≥100 mg/dL\], and sulfonylurea (SU) or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.
Interventions
- DRUG Insulin glargine
- DRUG LY2605541
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 466 participants |
| Start Date | 2012-05 |
| Est. Completion | 2013-12 |
| Phase | Phase 3 |
What the finished NCT01582451 record still lists
NCT01582451 is an interventional study that assigns participants to a tested intervention. The registered 466 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 (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Insulin glargine is the first listed.
NCT01582451 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01582451 about?
NCT01582451 is a clinical study titled "A Study of LY2605541 in Participants With Type 2 Diabetes Mellitus". The purpose of this study is to compare LY2605541 and insulin glargine using the following measures after participants have been treated for 26 weeks: * Change in participants' overall blood sugar control * The rate of night time low blood sugar episodes * The number of participants that reach bloo...
What is the current status of trial NCT01582451?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 466 participants. The study started on 2012-05. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01582451?
The interventions under investigation include: Insulin glargine (DRUG), LY2605541 (DRUG).
Who is sponsoring clinical trial NCT01582451?
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 NCT01582451's enrollment target sits among peer trials
466 816th of 2000 higher than 1,182 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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