Trial Outcomes & Findings for A Study of LY900014 in a Medtronic Pump (NCT NCT03760640)

NCT ID: NCT03760640

Last Updated: 2020-10-29

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 42 participants
• Primary outcome timeframe: Week 2 through Week 4
• Results posted on: 2020-10-29

Participant Flow

Participant milestones

Measure	Sequence 1 Participants received 100 units per milliliter (U/mL) of LY900014 or Insulin lispro delivered via continuous subcutaneous insulin infusion (CSII) using the Medtronic MiniMed 670G insulin pump. Period 1: LY900014 Period 2: Insulin Lispro (Humalog)	Sequence 2 Participants received 100 U/mL of LY900014 or Insulin lispro delivered via CSII using the Medtronic MiniMed 670G insulin pump. Period 1: Insulin Lispro (Humalog) Period 2: LY900014
Period 1 STARTED	20	22
Period 1 Received at Least 1 Dose of Study Drug	20	22
Period 1 COMPLETED	20	22
Period 1 NOT COMPLETED	0	0
Period 2 STARTED	20	22
Period 2 COMPLETED	20	22
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of LY900014 in a Medtronic Pump

Baseline characteristics by cohort

Measure	Sequence 1 n=20 Participants Participants received 100 units per milliliter (U/mL) of LY900014 or Humalog delivered via continuous subcutaneous insulin infusion (CSII) using the Medtronic MiniMed 670G insulin pump. Period 1: LY900014 Period 2: Humalog	Sequence 2 n=22 Participants Participants received 100 U/mL of LY900014 or Humalog delivered via CSII using the Medtronic MiniMed 670G insulin pump. Period 1: Humalog Period 2: LY900014	Total n=42 Participants Total of all reporting groups
Age, Continuous	47.5 years STANDARD_DEVIATION 14.9 • n=5 Participants	48.1 years STANDARD_DEVIATION 13.1 • n=7 Participants	47.8 years STANDARD_DEVIATION 13.8 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 2 through Week 4

Population: All randomized participants who received at least one dose of study drug and had at least one post-baseline data.

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.

Outcome measures

Measure	LY900014 n=42 Participants Participants received 100 U/mL of LY900014 delivered via CSII using the Medtronic MiniMed 670G insulin pump.	Insulin Lispro (Humalog) n=42 Participants Participants received 100 U/mL of Insulin lispro delivered via CSII using the Medtronic MiniMed 670G insulin pump.
Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) (24-Hour)	76.98 Percentage of Time Standard Error 0.857	77.84 Percentage of Time Standard Error 0.857

SECONDARY outcome

Timeframe: Week 2 through Week 4

Population: All randomized participants who received at least one dose of study drug and had at least one post-baseline data.

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.

Outcome measures

Measure	LY900014 n=42 Participants Participants received 100 U/mL of LY900014 delivered via CSII using the Medtronic MiniMed 670G insulin pump.	Insulin Lispro (Humalog) n=42 Participants Participants received 100 U/mL of Insulin lispro delivered via CSII using the Medtronic MiniMed 670G insulin pump.
Mean Sensor Glucose Value (24-Hour)	148.64 milligrams per deciliter (mg/dL) Standard Error 1.193	145.64 milligrams per deciliter (mg/dL) Standard Error 1.193

SECONDARY outcome

Timeframe: Week 2 through Week 4

Population: All randomized participants who received at least one dose of study drug and had at least post-baseline data.

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.

Outcome measures

Measure	LY900014 n=42 Participants Participants received 100 U/mL of LY900014 delivered via CSII using the Medtronic MiniMed 670G insulin pump.	Insulin Lispro (Humalog) n=41 Participants Participants received 100 U/mL of Insulin lispro delivered via CSII using the Medtronic MiniMed 670G insulin pump.
Percentage of Time Spent in Auto Mode	91.98 Percentage of Time Standard Error 0.829	91.42 Percentage of Time Standard Error 0.838

SECONDARY outcome

Timeframe: Week 2 through Week 4

Population: All randomized participants who received at least one dose of study drug and had at least one post-baseline data.

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.

Outcome measures

Measure	LY900014 n=42 Participants Participants received 100 U/mL of LY900014 delivered via CSII using the Medtronic MiniMed 670G insulin pump.	Insulin Lispro (Humalog) n=42 Participants Participants received 100 U/mL of Insulin lispro delivered via CSII using the Medtronic MiniMed 670G insulin pump.
Percentage of Time With Sensor Glucose Values <54 mg/dL (24-Hour)	0.34 Percentage of Time Standard Error 0.067	0.38 Percentage of Time Standard Error 0.067

SECONDARY outcome

Timeframe: Week 2 through Week 4

Population: All randomized participants with evaluable hypoglycemic data.

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.

Outcome measures

Measure	LY900014 n=42 Participants Participants received 100 U/mL of LY900014 delivered via CSII using the Medtronic MiniMed 670G insulin pump.	Insulin Lispro (Humalog) n=42 Participants Participants received 100 U/mL of Insulin lispro delivered via CSII using the Medtronic MiniMed 670G insulin pump.
Rate of Severe Hypoglycemic Events	0 Events/Participant/100 Years Standard Deviation 0	0 Events/Participant/100 Years Standard Deviation 0

SECONDARY outcome

Timeframe: Week 2 through Week 4

Population: All randomized participants who received at least one dose of study drug and had at least one post-baseline data.

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.

Outcome measures

Measure	LY900014 n=42 Participants Participants received 100 U/mL of LY900014 delivered via CSII using the Medtronic MiniMed 670G insulin pump.	Insulin Lispro (Humalog) n=42 Participants Participants received 100 U/mL of Insulin lispro delivered via CSII using the Medtronic MiniMed 670G insulin pump.
Total Daily Insulin Dose	42.59 Units (U)/day Standard Error 1.023	42.10 Units (U)/day Standard Error 1.023

Adverse Events

LY900014

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Insulin Lispro (Humalog)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	LY900014 n=42 participants at risk Participants received 100 U/mL of LY900014 delivered via CSII using the Medtronic MiniMed 670G insulin pump.	Insulin Lispro (Humalog) n=42 participants at risk Participants received 100 U/mL of Insulin lispro delivered via CSII using the Medtronic MiniMed 670G insulin pump.
General disorders Infusion site pain	9.5% 4/42 • Number of events 5 • Up To 10 Weeks All randomized participants who received at least one dose of study drug.	2.4% 1/42 • Number of events 1 • Up To 10 Weeks All randomized participants who received at least one dose of study drug.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: ClinicalTrials.gov@lilly.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60