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NCT01215955 · ClinicalTrials.gov registry record · Phase 4
Study of Insulin Lispro in Participants With Inadequately Controlled Type 2 Diabetes
A Phase 4 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,117
- Enrollment target
NCT01215955: Completed Phase 4 study, sponsored by Eli Lilly and Company.
NCT01215955 is a Phase 4 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 1,117 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (116% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01215955, a Phase 4 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,117 participants
- Enrollment target
Study Summary
Evidence regarding optimal methods of insulin dose adjustment is lacking in the literature. The purpose of this study is to evaluate the efficacy and safety of two approaches to escalate prandial insulin therapy in participants with type 2 diabetes mellitus not achieving adequate glycemic control on basal insulin.
Primary Outcome
The change from baseline to 24 weeks in the percentage of HbA1c in plasma. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables: fixed effects for treatment, country, sulfonylurea/meglitinide use, visit, treatment by visit interaction with baseline HbA1c as a covariate.
Interventions
- DRUG Insulin lispro
- DRUG Glargine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,117 participants |
| Start Date | 2010-12 |
| Est. Completion | 2013-01 |
| Phase | Phase 4 |
What the finished NCT01215955 record still lists
NCT01215955 is an interventional study that assigns participants to a tested intervention. Its 1,117 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (116% higher).
The record links to 0 conditions, and to 2 interventions - of which Insulin lispro is the first listed.
NCT01215955 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01215955 about?
NCT01215955 is a clinical study titled "Study of Insulin Lispro in Participants With Inadequately Controlled Type 2 Diabetes". Evidence regarding optimal methods of insulin dose adjustment is lacking in the literature. The purpose of this study is to evaluate the efficacy and safety of two approaches to escalate prandial insulin therapy in participants with type 2 diabetes mellitus not achieving adequate glycemic control on...
What is the current status of trial NCT01215955?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,117 participants. The study started on 2010-12. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01215955?
The interventions under investigation include: Insulin lispro (DRUG), Glargine (DRUG).
Who is sponsoring clinical trial NCT01215955?
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 NCT01215955's enrollment target sits among peer trials
1,117 65th of 2000 higher than 1,936 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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