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NCT01191268 · ClinicalTrials.gov registry record · Phase 3
A Study in Participants With Type 2 Diabetes Mellitus (AWARD-4)
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 884
- Enrollment target
NCT01191268: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT01191268 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 884 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01191268, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 884 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy and safety of LY2189265 in comparison to Insulin Glargine, both in combination with Insulin Lispro (plus or minus Metformin), in participants with Type 2 Diabetes treated with 1 or 2 injections of insulin.
Primary Outcome
Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, baseline metformin, and baseline HbA1c.
Interventions
- DRUG Insulin Glargine
- DRUG Insulin Lispro
- DRUG LY2189265
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 884 participants |
| Start Date | 2010-11 |
| Est. Completion | 2012-09 |
| Phase | Phase 3 |
What the finished NCT01191268 record still lists
NCT01191268 is an interventional study that assigns participants to a tested intervention. The registered 884 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% higher).
The record links to 0 conditions, and to 3 interventions - of which Insulin Glargine is the first listed.
NCT01191268 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01191268 about?
NCT01191268 is a clinical study titled "A Study in Participants With Type 2 Diabetes Mellitus (AWARD-4)". The purpose of this study is to assess the efficacy and safety of LY2189265 in comparison to Insulin Glargine, both in combination with Insulin Lispro (plus or minus Metformin), in participants with Type 2 Diabetes treated with 1 or 2 injections of insulin.
What is the current status of trial NCT01191268?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 884 participants. The study started on 2010-11. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01191268?
The interventions under investigation include: Insulin Glargine (DRUG), Insulin Lispro (DRUG), LY2189265 (DRUG).
Who is sponsoring clinical trial NCT01191268?
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 NCT01191268's enrollment target sits among peer trials
884 366th of 2000 higher than 1,635 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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