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NCT01454284 · ClinicalTrials.gov registry record · Phase 3
A Study in Participants With Type I Diabetes Mellitus
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,114
- Enrollment target
NCT01454284: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT01454284 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 1,114 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01454284, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,114 participants
- Enrollment target
Study Summary
The purpose of this study is: * To compare blood sugar control on LY2605541 with insulin glargine after 52 weeks of treatment. * To compare the rate of nocturnal low blood sugar episodes on LY2605541 with insulin glargine during 52 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 52 weeks of treatment. * To compare the rate of low blood sugar episodes on LY2605541 with insulin glargine during 52 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 (country, baseline low density lipoprotein cholesterol \[LDL-C\] \[\<100 milligrams/deciliter (mg/dL) (2.6 millimoles/liter \[mmol/L\]) and ≥100 mg/dL (2.6 mmol/L)\], baseline prior basal insulin therapy \[insulin glargine/detemir/other\]), visit, treatment-by-vi
Interventions
- DRUG Glargine
- DRUG Insulin Lispro
- DRUG LY2605541
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,114 participants |
| Start Date | 2012-01 |
| Est. Completion | 2014-02 |
| Phase | Phase 3 |
What the finished NCT01454284 record still lists
NCT01454284 is an interventional study that assigns participants to a tested intervention. Its 1,114 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% higher).
The record links to 0 conditions, and to 3 interventions - of which Glargine is the first listed.
NCT01454284 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01454284 about?
NCT01454284 is a clinical study titled "A Study in Participants With Type I Diabetes Mellitus". The purpose of this study is: * To compare blood sugar control on LY2605541 with insulin glargine after 52 weeks of treatment. * To compare the rate of nocturnal low blood sugar episodes on LY2605541 with insulin glargine during 52 weeks of treatment. * To compare the number of participants on LY26...
What is the current status of trial NCT01454284?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,114 participants. The study started on 2012-01. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01454284?
The interventions under investigation include: Glargine (DRUG), Insulin Lispro (DRUG), LY2605541 (DRUG).
Who is sponsoring clinical trial NCT01454284?
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 NCT01454284's enrollment target sits among peer trials
1,114 251st of 2000 higher than 1,750 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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