- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03760640
A Study of LY900014 in a Medtronic Pump
October 2, 2020 updated by: Eli Lilly and Company
Evaluation of LY900014 in a Medtronic Pump
The purpose of this study is to compare the study drug LY900014 to insulin lispro (Humalog) when both are delivered by the Medtronic MiniMed 670G System in adults with type 1 diabetes (T1D).
The study will consist of two treatment periods of 4 weeks.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30318
- Atlanta Diabetes Associates
-
-
Minnesota
-
Saint Louis Park, Minnesota, United States, 55416
- International Diabetes Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants must have been diagnosed with type 1 diabetes and have been using insulin continuously for at least 12 months
- 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 had more than 1 emergency treatment for very low blood glucose or any hospitalizations for poor glucose control (very high blood sugar or diabetic ketoacidosis) in the last 6 months
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Administered SC
Other Names:
|
Active Comparator: Insulin Lispro (Humalog)
Participants received 100 U/mL of Insulin lispro (Humalog) administered via CSII by the Medtronic MiniMed 670G insulin pump.
|
Administered SC
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) (24-Hour)
Time Frame: Week 2 through Week 4
|
Least Square (LS) mean was determined by mixed-model repeated measures (MMRM) with baseline, period, sequence, strata (Hemoglobin A1c (HbA1c) [<=7.0%,
>7.0%] and percentage of time with sensor glucose values from 70 to 180 mg/dL over the 2 weeks prior to randomization [<=75%, >75%]), treatment (Type III sum of squares) as fixed factors.
|
Week 2 through Week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Sensor Glucose Value (24-Hour)
Time Frame: Week 2 through Week 4
|
LS mean was determined by MMRM with baseline, period, sequence, strata (HbA1c [<=7.0%,
>7.0%] and percentage of time with sensor glucose values from 70 to 180 mg/dL over the 2 weeks prior to randomization [<=75%, >75%]), treatment (Type III sum of squares) as fixed factors.
|
Week 2 through Week 4
|
Percentage of Time Spent in Auto Mode
Time Frame: Week 2 through Week 4
|
LS mean was determined by MMRM with baseline, period, sequence, strata (HbA1c [<=7.0%,
>7.0%] and percentage of time with sensor glucose values from 70 to 180 mg/dL over the 2 weeks prior to randomization [<=75%, >75%]), treatment (Type III sum of squares) as fixed factors.
|
Week 2 through Week 4
|
Percentage of Time With Sensor Glucose Values <54 mg/dL (24-Hour)
Time Frame: Week 2 through Week 4
|
LS mean was determined by MMRM with baseline, period, sequence, strata (HbA1c [<=7.0%,
>7.0%] and percentage of time with sensor glucose values from 70 to 180 mg/dL over the 2 weeks prior to randomization [<=75%, >75%]), treatment (Type III sum of squares) as fixed factors.
|
Week 2 through Week 4
|
Rate of Severe Hypoglycemic Events
Time Frame: Week 2 through Week 4
|
Severe hypoglycemic is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions.
During these episodes, the participant has an altered mental status and cannot assist in his or her own care, or may be semiconscious or unconscious, or experience coma with or without seizures, and may require parenteral therapy.
Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within a treatment group *36525.
No severe hypoglycemia was reported for this study.
|
Week 2 through Week 4
|
Total Daily Insulin Dose
Time Frame: Week 2 through Week 4
|
LS mean was determined by MMRM with baseline, period, sequence, strata (HbA1c [<=7.0%,
>7.0%] and percentage of time with sensor glucose values from 70 to 180 mg/dL over the 2 weeks prior to randomization [<=75%, >75%]), treatment (Type III sum of squares) as fixed factors.
|
Week 2 through Week 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 18, 2019
Primary Completion (Actual)
October 7, 2019
Study Completion (Actual)
October 7, 2019
Study Registration Dates
First Submitted
November 28, 2018
First Submitted That Met QC Criteria
November 29, 2018
First Posted (Actual)
November 30, 2018
Study Record Updates
Last Update Posted (Actual)
October 29, 2020
Last Update Submitted That Met QC Criteria
October 2, 2020
Last Verified
October 15, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16917
- I8B-MC-ITSM (Other Identifier: Eli Lilly and Company)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later.
Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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