Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
42 participants
INTERVENTIONAL
2019-02-18
2019-10-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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LY900014
Participants received 100 units per milliliter (U/mL) of LY900014 administered via continuous subcutaneous insulin infusion (CSII) by the Medtronic MiniMed 670G insulin pump.
LY900014
Administered SC
Insulin Lispro (Humalog)
Participants received 100 U/mL of Insulin lispro (Humalog) administered via CSII by the Medtronic MiniMed 670G insulin pump.
Insulin Lispro
Administered SC
Interventions
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LY900014
Administered SC
Insulin Lispro
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must be using an insulin pump with "rapid-acting insulin" for at least 6 months and the same "rapid acting insulin" for at least the past 30 days
* Participants must have hemoglobin A1c (HbA1c) values ≥6.0% and ≤8.0%
* Participants must have been using the MiniMed 670G insulin pump for at least the past 90 days
* Participants must use their Guardian (3) sensor at least an average of 75% of the time and remain in Auto Mode an average of 70% of the time
Exclusion Criteria
* Participants must not have significant abnormal accumulation of fat, loss of fat tissue, or scars just under the skin in areas of infusion or have a history of an infection at an infusion site within 90 days prior to screening
* Participants must not have a total daily insulin dose \>100 units
* Participants must not be receiving any oral or injectable medication intended for the treatment of diabetes other than rapid-acting analog insulin via CSII in the 30 days prior to screening
* Participants must not have major problems with their heart, kidneys, liver, or have a blood disorder
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Atlanta Diabetes Associates
Atlanta, Georgia, United States
International Diabetes Center
Saint Louis Park, Minnesota, United States
Countries
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References
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Bode B, Carlson A, Liu R, Hardy T, Bergenstal R, Boyd J, Morrett S, Ignaut D. Ultrarapid Lispro Demonstrates Similar Time in Target Range to Lispro with a Hybrid Closed-Loop System. Diabetes Technol Ther. 2021 Dec;23(12):828-836. doi: 10.1089/dia.2021.0184. Epub 2021 Oct 26.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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I8B-MC-ITSM
Identifier Type: OTHER
Identifier Source: secondary_id
16917
Identifier Type: -
Identifier Source: org_study_id