A Study of LY900014 in a Medtronic Pump

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

LY900014

Insulin Lispro

About this trial

This is an interventional treatment trial for Type1 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Atlanta Diabetes Associates
International Diabetes Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LY900014

Insulin Lispro (Humalog)

Arm Description

Participants received 100 units per milliliter (U/mL) of LY900014 administered via continuous subcutaneous insulin infusion (CSII) by the Medtronic MiniMed 670G insulin pump.

Participants received 100 U/mL of Insulin lispro (Humalog) administered via CSII by the Medtronic MiniMed 670G insulin pump.

Outcomes

Primary Outcome Measures

Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) (24-Hour)

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.

Secondary Outcome Measures

Mean Sensor Glucose Value (24-Hour)

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.

Percentage of Time Spent in Auto Mode

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.

Percentage of Time With Sensor Glucose Values <54 mg/dL (24-Hour)

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.

Rate of Severe Hypoglycemic Events

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.

Total Daily Insulin Dose

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.

Full Information

NCT ID

NCT03760640

First Posted

November 28, 2018

Last Updated

October 2, 2020

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT03760640

Brief Title

A Study of LY900014 in a Medtronic Pump

Official Title

Evaluation of LY900014 in a Medtronic Pump

Study Type

Interventional

2. Study Status

Record Verification Date

October 15, 2019

Overall Recruitment Status

Completed

Study Start Date

February 18, 2019 (Actual)

Primary Completion Date

October 7, 2019 (Actual)

Study Completion Date

October 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type1 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LY900014

Arm Type

Experimental

Arm Description

Participants received 100 units per milliliter (U/mL) of LY900014 administered via continuous subcutaneous insulin infusion (CSII) by the Medtronic MiniMed 670G insulin pump.

Arm Title

Insulin Lispro (Humalog)

Arm Type

Active Comparator

Arm Description

Participants received 100 U/mL of Insulin lispro (Humalog) administered via CSII by the Medtronic MiniMed 670G insulin pump.

Intervention Type

Drug

Intervention Name(s)

LY900014

Other Intervention Name(s)

Ultra-Rapid Lispro, Lyumjev

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Insulin Lispro

Other Intervention Name(s)

Humalog, LY275585

Intervention Description

Administered SC

Primary Outcome Measure Information:

Title

Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) (24-Hour)

Description

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.

Time Frame

Week 2 through Week 4

Secondary Outcome Measure Information:

Title

Mean Sensor Glucose Value (24-Hour)

Description

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.

Time Frame

Week 2 through Week 4

Title

Percentage of Time Spent in Auto Mode

Description

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.

Time Frame

Week 2 through Week 4

Title

Percentage of Time With Sensor Glucose Values <54 mg/dL (24-Hour)

Description

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.

Time Frame

Week 2 through Week 4

Title

Rate of Severe Hypoglycemic Events

Description

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.

Time Frame

Week 2 through Week 4

Title

Total Daily Insulin Dose

Description

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.

Time Frame

Week 2 through Week 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Atlanta Diabetes Associates

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30318

Country

United States

Facility Name

International Diabetes Center

City

Saint Louis Park

State/Province

Minnesota

ZIP/Postal Code

55416

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 URL

http://www.clinicalstudydatarequest.com

Citations:

PubMed Identifier

34270335

Citation

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.

Results Reference

derived

Type1 Diabetes Mellitus

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial