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NCT03433677 · ClinicalTrials.gov registry record · Phase 3
A Study of LY900014 and Insulin Lispro With an External Continuous Subcutaneous Insulin Infusion System in Adult Participants With Type 1 Diabetes
A Phase 3 study of Diabetes type1, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 49
- Enrollment target
- 5
- Study locations
NCT03433677: Completed Phase 3 study of Diabetes type1, sponsored by Eli Lilly and Company.
NCT03433677 is a Phase 3 study of Diabetes type1 that has completed, run by Eli Lilly and Company. The registered enrollment target is 49 participants, below the 126-participant average among 4 other Diabetes type1 trials with a reported enrollment target (61% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03433677, a Phase 3 study of Diabetes type1, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 49 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of this study is to evaluate the compatibility and safety of LY900014 and insulin lispro with an external continuous subcutaneous insulin infusion system in adult participants with type 1 diabetes.
Primary Outcome
Infusion set failure events are defined as premature infusion set changes, due to a pump occlusion alarm OR due to unexplained hyperglycemia with blood glucose (SMBG) \>250 milligrams per deciliter (mg/dL) (13.9 millimoles per liter \[mmol/L\]) that does not decrease within 1 hour following a correction bolus delivered via the pump during the 6 week treatment period. Aggregate rate was calculated for each participant as the total number of events while the participant is on study treatment divid
Conditions Studied
Interventions
- DRUG Insulin lispro
- DRUG LY900014
Study Locations (5)
Other
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Seville
- For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. - Seville
California
- Valley Research - Fresno
Colorado
- Barbara Davis Center for Childhood Diabetes - Aurora
Georgia
- Atlanta Diabetes Associates - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2018-02-21 |
| Est. Completion | 2018-09-04 |
| Phase | Phase 3 |
What the finished NCT03433677 record still lists
NCT03433677 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 126-participant average among 4 other Diabetes type1 trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Diabetes type1 appearing as the primary indexed condition, and to 2 interventions - of which Insulin lispro is the first listed.
NCT03433677 lists 5 locations in 4 states (Other, California, Colorado).
Frequently Asked Questions
What is clinical trial NCT03433677 about?
NCT03433677 is a clinical study titled "A Study of LY900014 and Insulin Lispro With an External Continuous Subcutaneous Insulin Infusion System in Adult Participants With Type 1 Diabetes". The purpose of this study is to evaluate the compatibility and safety of LY900014 and insulin lispro with an external continuous subcutaneous insulin infusion system in adult participants with type 1 diabetes.
What is the current status of trial NCT03433677?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 49 participants. The study started on 2018-02-21. Estimated completion is 2018-09-04.
What conditions does trial NCT03433677 study?
This clinical trial studies the following conditions: Diabetes type1.
What interventions are being tested in trial NCT03433677?
The interventions under investigation include: Insulin lispro (DRUG), LY900014 (DRUG).
Who is sponsoring clinical trial NCT03433677?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03433677 being conducted?
This trial has 5 study locations across California, Colorado, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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