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NCT01435616 · ClinicalTrials.gov registry record · Phase 3
A Study in Patients With Type 2 Diabetes Mellitus
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,538
- Enrollment target
NCT01435616: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT01435616 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 1,538 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01435616, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,538 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 night time 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 after 52 weeks of treatment
Primary Outcome
HbA1C is a test that measures a person's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) with baseline HbA1c measurement, stratification factors (country, low density lipoprotein-cholesterol \[LDL-C, \< 100 milligrams per deciliter {mg/dL} and ≥ 100 mg/dL\] and sulfonylurea \[SU\]/meglitinide use), visit, treatment, and visit-by-treatment interaction as fixed effects.
Interventions
- DRUG Glargine
- DRUG LY2605541
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,538 participants |
| Start Date | 2011-11 |
| Est. Completion | 2014-01 |
| Phase | Phase 3 |
What the finished NCT01435616 record still lists
NCT01435616 is an interventional study that assigns participants to a tested intervention. Its 1,538 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 (99% higher).
The record links to 0 conditions, and to 2 interventions - of which Glargine is the first listed.
NCT01435616 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01435616 about?
NCT01435616 is a clinical study titled "A Study in Patients With Type 2 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 night time low blood sugar episodes on LY2605541 with insulin glargine during 52 weeks of treatment. * To compare the number of participants on LY2...
What is the current status of trial NCT01435616?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,538 participants. The study started on 2011-11. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01435616?
The interventions under investigation include: Glargine (DRUG), LY2605541 (DRUG).
Who is sponsoring clinical trial NCT01435616?
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 NCT01435616's enrollment target sits among peer trials
1,538 151st of 2000 higher than 1,849 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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