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NCT01790438 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare a New Long-Acting Insulin (LY2605541) and Human Insulin NPH in Participants With Type 2 Diabetes
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 641
- Enrollment target
NCT01790438: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT01790438 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 641 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01790438, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 641 participants
- Enrollment target
Study Summary
The purpose of this study is to compare LY2605541 and human insulin isophane suspension (NPH) using the following measures for participants treated for up to 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 night time blood sugar episodes * The total number of low blood sugar episodes reported
Primary Outcome
Glycosylated hemoglobin A1 (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 by mixed model repeated measures (MMRM) using treatment, stratification factors (country, sulfonylureas/meglitinide use \[Yes/No\]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects.
Interventions
- DRUG LY2605541
- DRUG Human Insulin NPH
- DRUG Oral Antihyperglycemic Medications (OAM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 641 participants |
| Start Date | 2013-03 |
| Est. Completion | 2014-05 |
| Phase | Phase 3 |
What the finished NCT01790438 record still lists
NCT01790438 is an interventional study that assigns participants to a tested intervention. The registered 641 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 (17% lower).
The record links to 0 conditions, and to 3 interventions - of which LY2605541 is the first listed.
NCT01790438 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01790438 about?
NCT01790438 is a clinical study titled "A Study to Compare a New Long-Acting Insulin (LY2605541) and Human Insulin NPH in Participants With Type 2 Diabetes". The purpose of this study is to compare LY2605541 and human insulin isophane suspension (NPH) using the following measures for participants treated for up to 26 weeks: * Change in participants' overall blood sugar control * The rate of night time low blood sugar episodes * The number of participant...
What is the current status of trial NCT01790438?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 641 participants. The study started on 2013-03. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01790438?
The interventions under investigation include: LY2605541 (DRUG), Human Insulin NPH (DRUG), Oral Antihyperglycemic Medications (OAM) (DRUG).
Who is sponsoring clinical trial NCT01790438?
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 NCT01790438's enrollment target sits among peer trials
641 575th of 2000 higher than 1,425 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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