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NCT01481779 · ClinicalTrials.gov registry record · Phase 3
A Study in Participants With Type 1 Diabetes Mellitus
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 455
- Enrollment target
NCT01481779: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT01481779 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 455 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01481779, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 455 participants
- Enrollment target
Study Summary
The purpose of this study is: * To compare the blood sugar control of LY2605541 with insulin glargine after 78 weeks of treatment. * To compare the rate of night-time low blood sugar episodes on LY2605541 with insulin glargine during 78 weeks of treatment. * To compare the number of participants on LY2605541 reaching blood sugar targets without low blood sugar episodes at night to those taking insulin glargine after 78 weeks of treatment. * To compare the rate of hypoglycemia episodes on LY2605541 with insulin glargine during 78 weeks of treatment.
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 treatment, stratification factors (baseline low-density lipoprotein cholesterol \[LDL-C\] \[\<100 milligrams per deciliter (mg/dL) and ≥100 mg/dL\] and country), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect.
Interventions
- DRUG Glargine
- DRUG Insulin Lispro
- DRUG LY2605541
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 455 participants |
| Start Date | 2012-01 |
| Est. Completion | 2014-06 |
| Phase | Phase 3 |
What the finished NCT01481779 record still lists
NCT01481779 is an interventional study that assigns participants to a tested intervention. The registered 455 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 (41% lower).
The record links to 0 conditions, and to 3 interventions - of which Glargine is the first listed.
NCT01481779 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01481779 about?
NCT01481779 is a clinical study titled "A Study in Participants With Type 1 Diabetes Mellitus". The purpose of this study is: * To compare the blood sugar control of LY2605541 with insulin glargine after 78 weeks of treatment. * To compare the rate of night-time low blood sugar episodes on LY2605541 with insulin glargine during 78 weeks of treatment. * To compare the number of participants on...
What is the current status of trial NCT01481779?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 455 participants. The study started on 2012-01. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01481779?
The interventions under investigation include: Glargine (DRUG), Insulin Lispro (DRUG), LY2605541 (DRUG).
Who is sponsoring clinical trial NCT01481779?
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 NCT01481779's enrollment target sits among peer trials
455 829th of 2000 higher than 1,170 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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