A Study of LY900014 in a Medtronic Pump

Phase 2

Completed

• Conditions: Type1 Diabetes Mellitus
• Interventions: Drug: LY900014; Drug: Insulin Lispro

• Registration Number: NCT03760640
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-28
• Study First Submitted QC: 2018-11-29
• Study First Posted: 2018-11-30
• Study Start: 2019-02-18
• Primary Completion: 2019-10-07
• Study Completion: 2019-10-07
• Status Verified: 2019-10-15
• Results First Submitted: 2020-10-02
• Results First Submitted QC: 2020-10-02
• Last Update Submitted: 2020-10-02
• Results First Posted: 2020-10-29
• Last Update Posted: 2020-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LY900014	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.
Insulin Lispro (Humalog)	Insulin Lispro	Participants received 100 U/mL of Insulin lispro (Humalog) administered via CSII by the Medtronic MiniMed 670G insulin pump.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mean Sensor Glucose Value (24-Hour)	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.
Percentage of Time Spent in Auto Mode	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.
Percentage of Time With Sensor Glucose Values <54 mg/dL (24-Hour)	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.
Rate of Severe Hypoglycemic Events	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.
Total Daily Insulin Dose	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.

Trial Locations

Locations (2)

Atlanta Diabetes Associates; 🇺🇸 Atlanta, Georgia, United States

International Diabetes Center; 🇺🇸 Saint Louis Park, Minnesota, United States