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NCT01468987 · ClinicalTrials.gov registry record · Phase 3

A Study in Participants With Type 2 Diabetes Mellitus

A Phase 3 study, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 3
Development phase
1,369
Enrollment target

NCT01468987: Completed Phase 3 study, sponsored by Eli Lilly and Company.

NCT01468987 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 1,369 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01468987, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 3
Development phase
1,369 participants
Enrollment target

Study Summary

The purpose of this study is: * To compare blood glucose (blood sugar) control on LY2605541 with insulin glargine after 26 weeks of treatment. * To compare the rate of night time hypoglycemia (low blood glucose) on LY2605541 with insulin glargine during 26 weeks of treatment. * To compare the number of participants on LY2605541 reaching blood glucose targets without hypoglycemia episodes at night to those taking insulin glargine after 26 weeks of treatment. * To compare the rate of hypoglycemia over a 24-hour period on LY2605541 with insulin glargine during 26 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 stratification factors (country, low-density lipoprotein cholesterol \[LDL-C, \<100 milligrams per deciliter (mg/dL) and ≥100 mg/dL\], and number of insulin injections at baseline \[1, 2, or ≥3\]), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.

Interventions

  • DRUG Insulin Glargine
  • DRUG Insulin Lispro
  • DRUG LY2605541

Trial Details

FieldValue
Enrollment Target 1,369 participants
Start Date 2011-12
Est. Completion 2013-08
Phase Phase 3
Eli Lilly and Company

1,341 total trials

What the finished NCT01468987 record still lists

NCT01468987 is an interventional study that assigns participants to a tested intervention. Its 1,369 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 (77% higher).

The record links to 0 conditions, and to 3 interventions - of which Insulin Glargine is the first listed.

NCT01468987 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01468987 about?

NCT01468987 is a clinical study titled "A Study in Participants With Type 2 Diabetes Mellitus". The purpose of this study is: * To compare blood glucose (blood sugar) control on LY2605541 with insulin glargine after 26 weeks of treatment. * To compare the rate of night time hypoglycemia (low blood glucose) on LY2605541 with insulin glargine during 26 weeks of treatment. * To compare the numbe...

What is the current status of trial NCT01468987?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,369 participants. The study started on 2011-12. Estimated completion is 2013-08.

What interventions are being tested in trial NCT01468987?

The interventions under investigation include: Insulin Glargine (DRUG), Insulin Lispro (DRUG), LY2605541 (DRUG).

Who is sponsoring clinical trial NCT01468987?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01468987's enrollment target sits among peer trials

1,369 179th of 2000 higher than 1,822 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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Source: ClinicalTrials.gov NCT01468987, the US trial registry maintained by the National Library of Medicine. NCT01468987 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.