Trial Outcomes & Findings for A Study of LY900014 and Insulin Degludec in Participants With Type 1 Diabetes (NCT NCT04585776)
NCT ID: NCT04585776
Last Updated: 2022-06-03
Results Overview
Percentage of Time with Sensor Glucose Values Between 70 and 180 mg/dL (both inclusive) with CGM.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Day 46
Results posted on
2022-06-03
Participant Flow
Participant milestones
| Measure |
LY900014 + Insulin Degludec
LY900014 (100 units/milliliter (U/mL)) is a prandial insulin administered subcutaneously (SC) 0-2 minutes before meals. Insulin degludec (100 U/mL) is a basal insulin administered once daily SC. Participants received individually adjusted insulin doses during the 35-day titration period. The target glucose values were: fasting glucose 80-110 milligrams per deciliter (mg/dL), overnight glucose excursion (the difference between bedtime and prebreakfast glucose levels) \< or = +/- 30 mg/dL, postprandial glucose peak \<140 mg/dL or \<20% increase from premeal level. Following the titration period, there was an 11-day maintenance period during which the doses were kept unchanged unless for safety reasons.
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|---|---|
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Overall Study
STARTED
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31
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Overall Study
Received Atleast 1 Dose of Study Drug
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31
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Overall Study
COMPLETED
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31
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of LY900014 and Insulin Degludec in Participants With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
LY900014 + Insulin Degludec
n=31 Participants
LY900014 (100 U/mL) is a prandial insulin administered SC 0-2 minutes before meals. Insulin degludec (100 U/mL) is a basal insulin administered once daily SC. Participants received individually adjusted insulin doses during the 35-day titration period. The target glucose values were: fasting glucose 80-110 mg/dL, overnight glucose excursion (the difference between bedtime and prebreakfast glucose levels) \< or = +/- 30 mg/dL, postprandial glucose peak \<140 mg/dL or \<20% increase from premeal level. Following the titration period, there was an 11-day maintenance period during which the doses were kept unchanged unless for safety reasons.
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|---|---|
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Age, Continuous
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42.20 years
STANDARD_DEVIATION 13.75 • n=93 Participants
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Sex: Female, Male
Female
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18 Participants
n=93 Participants
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Sex: Female, Male
Male
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13 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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30 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=93 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=93 Participants
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Race (NIH/OMB)
White
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30 Participants
n=93 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=93 Participants
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Region of Enrollment
United States
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31 Participants
n=93 Participants
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PRIMARY outcome
Timeframe: Day 46Population: All participants who received at least one dose of study drug and had post-baseline sensor glucose values.
Percentage of Time with Sensor Glucose Values Between 70 and 180 mg/dL (both inclusive) with CGM.
Outcome measures
| Measure |
LY900014 + Insulin Degludec
n=31 Participants
LY900014 (100 U/mL) is a prandial insulin administered SC 0-2 minutes before meals. Insulin degludec (100 U/mL) is a basal insulin administered once daily SC. Participants received individually adjusted insulin doses during the 35-day titration period. The target glucose values were: fasting glucose 80-110 mg/dL, overnight glucose excursion (the difference between bedtime and prebreakfast glucose levels) \< or = +/- 30 mg/dL, postprandial glucose peak \<140 mg/dL or \<20% increase from premeal level. Following the titration period, there was an 11-day maintenance period during which the doses were kept unchanged unless for safety reasons.
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|---|---|
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Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) With Continuous Glucose Monitoring (CGM)
Day-time
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71.57 percentage of time
Standard Deviation 14.370
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Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) With Continuous Glucose Monitoring (CGM)
Night-time
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65.76 percentage of time
Standard Deviation 19.846
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Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) With Continuous Glucose Monitoring (CGM)
24-Hour Period
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70.18 percentage of time
Standard Deviation 14.589
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SECONDARY outcome
Timeframe: Day 46Population: All participants who received at least one dose of study drug and had post-baseline ICR values.
ICR was evaluated to estimate how many carbohydrates will be covered by one unit of insulin.
Outcome measures
| Measure |
LY900014 + Insulin Degludec
n=31 Participants
LY900014 (100 U/mL) is a prandial insulin administered SC 0-2 minutes before meals. Insulin degludec (100 U/mL) is a basal insulin administered once daily SC. Participants received individually adjusted insulin doses during the 35-day titration period. The target glucose values were: fasting glucose 80-110 mg/dL, overnight glucose excursion (the difference between bedtime and prebreakfast glucose levels) \< or = +/- 30 mg/dL, postprandial glucose peak \<140 mg/dL or \<20% increase from premeal level. Following the titration period, there was an 11-day maintenance period during which the doses were kept unchanged unless for safety reasons.
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|---|---|
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Insulin to Carbohydrate Ratio (ICR)
Breakfast
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9.03 grams per insulin unit (g/U)
Standard Deviation 3.490
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Insulin to Carbohydrate Ratio (ICR)
Lunch
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9.07 grams per insulin unit (g/U)
Standard Deviation 3.423
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Insulin to Carbohydrate Ratio (ICR)
Dinner
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9.11 grams per insulin unit (g/U)
Standard Deviation 3.529
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Insulin to Carbohydrate Ratio (ICR)
Across meals
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9.05 grams per insulin unit (g/U)
Standard Deviation 3.398
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SECONDARY outcome
Timeframe: Day 46Population: All participants who received at least one dose of study drug and had post-baseline values for prandial and total daily insulin dose.
Prandial:TDD ratio
Outcome measures
| Measure |
LY900014 + Insulin Degludec
n=29 Participants
LY900014 (100 U/mL) is a prandial insulin administered SC 0-2 minutes before meals. Insulin degludec (100 U/mL) is a basal insulin administered once daily SC. Participants received individually adjusted insulin doses during the 35-day titration period. The target glucose values were: fasting glucose 80-110 mg/dL, overnight glucose excursion (the difference between bedtime and prebreakfast glucose levels) \< or = +/- 30 mg/dL, postprandial glucose peak \<140 mg/dL or \<20% increase from premeal level. Following the titration period, there was an 11-day maintenance period during which the doses were kept unchanged unless for safety reasons.
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Ratio of Prandial Dose to Total Daily Dose (TDD) of Insulin
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52.06 percentage of insulin dose
Standard Deviation 12.282
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SECONDARY outcome
Timeframe: Day 46Population: All participants who received at least one dose of study drug and had post-baseline values for ICR and TDD.
ICR×TDD is determined to evaluate the relationship between insulin to carbohydrate ratio (g/U) and the total daily insulin dose (U/day).
Outcome measures
| Measure |
LY900014 + Insulin Degludec
n=29 Participants
LY900014 (100 U/mL) is a prandial insulin administered SC 0-2 minutes before meals. Insulin degludec (100 U/mL) is a basal insulin administered once daily SC. Participants received individually adjusted insulin doses during the 35-day titration period. The target glucose values were: fasting glucose 80-110 mg/dL, overnight glucose excursion (the difference between bedtime and prebreakfast glucose levels) \< or = +/- 30 mg/dL, postprandial glucose peak \<140 mg/dL or \<20% increase from premeal level. Following the titration period, there was an 11-day maintenance period during which the doses were kept unchanged unless for safety reasons.
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|---|---|
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Product of Insulin to Carbohydrate Ratio and Total Daily Dose (ICR×TDD)
Breakfast
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411.1 g/day
Standard Deviation 169.77
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Product of Insulin to Carbohydrate Ratio and Total Daily Dose (ICR×TDD)
Lunch
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421.3 g/day
Standard Deviation 184.18
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Product of Insulin to Carbohydrate Ratio and Total Daily Dose (ICR×TDD)
Dinner
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427.6 g/day
Standard Deviation 206.98
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Product of Insulin to Carbohydrate Ratio and Total Daily Dose (ICR×TDD)
Across meals
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420.0 g/day
Standard Deviation 183.52
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Adverse Events
LY900014 + Insulin Degludec
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60