Trial Outcomes & Findings for A Study of LY900014 (Lyumjev) Versus Insulin Lispro (Humalog) in Participants With Type 1 Diabetes (NCT NCT05262387)
NCT ID: NCT05262387
Last Updated: 2024-09-03
Results Overview
Changes in PG from the start (0 minute) to end of exercise (60 minutes) were analyzed using a mixed-effect model. The model included treatment (Lyumjev with 50% basal reduction, Lyumjev with 100% basal reduction, Humalog with 50% basal reduction, and Humalog with 100% basal reduction), sequence, period, timepoint, treatment-by-timepoint interaction as fixed effects, and participant-within-sequence as a random effect.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
Start (0 minute) to end of exercise (60 minutes)
Results posted on
2024-09-03
Participant Flow
Participants were randomized to 4 treatment sequences (ADBC, BACD, CBDA, and DCAB), with each sequence having 4 periods where participants were crossed over between the periods. A washout period of at least 3 days was maintained between each treatment period.
Participant milestones
| Measure |
Treatment Sequence 1: ADBC
Period 1: Lyumjev with 50% basal rate reduction (Treatment A)
Period 2: Humalog with 100% basal rate reduction (Treatment D)
Period 3: Lyumjev with 100% basal rate reduction (Treatment B)
Period 4: Humalog with 50% basal rate reduction (Treatment C)
Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously.
|
Treatment Sequence 2: BACD
Period 1: Lyumjev with 100% basal rate reduction (Treatment B)
Period 2: Lyumjev with 50% basal rate reduction (Treatment A)
Period 3: Humalog with 50% basal rate reduction (Treatment C)
Period 4: Humalog with 100% basal rate reduction (Treatment D)
Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously.
|
Treatment Sequence 3: CBDA
Period 1: Humalog with 50% basal rate reduction (Treatment C)
Period 2: Lyumjev with 100% basal rate reduction (Treatment B)
Period 3: Humalog with 100% basal rate reduction (Treatment D)
Period 4: Lyumjev with 50% basal rate reduction (Treatment A)
Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously.
|
Treatment Sequence 4: DCAB
Period 1: Humalog with 100% basal rate reduction (Treatment D)
Period 2: Humalog with 50% basal rate reduction (Treatment C)
Period 3: Lyumjev with 50% basal rate reduction (Treatment A)
Period 4: Lyumjev with 100% basal rate reduction (Treatment B)
Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously.
|
|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
6
|
6
|
7
|
6
|
|
Treatment Period 1
Received at Least 1 Dose of Study Drug
|
6
|
6
|
7
|
6
|
|
Treatment Period 1
COMPLETED
|
6
|
6
|
7
|
6
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 2
STARTED
|
6
|
6
|
7
|
6
|
|
Treatment Period 2
COMPLETED
|
6
|
6
|
7
|
6
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 3
STARTED
|
6
|
6
|
7
|
6
|
|
Treatment Period 3
COMPLETED
|
6
|
6
|
7
|
6
|
|
Treatment Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 4
STARTED
|
6
|
6
|
7
|
6
|
|
Treatment Period 4
COMPLETED
|
6
|
6
|
7
|
6
|
|
Treatment Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of LY900014 (Lyumjev) Versus Insulin Lispro (Humalog) in Participants With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
All Participants
n=25 Participants
Participants received Lyumjev with 50% basal rate reduction (Treatment A) or Lyumjev with 100% basal rate reduction (Treatment B) or Humalog with 50% basal rate reduction (Treatment C) or Humalog with 100% basal rate reduction (Treatment D) subcutaneously on Day 1 in Treatment Period 1 to 4 as per assigned randomized treatment sequence. A washout period of at least 3 days was maintained between all the treatment periods.
|
|---|---|
|
Age, Continuous
|
36.7 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Start (0 minute) to end of exercise (60 minutes)Population: All participants who received at least one dose of study drug.
Changes in PG from the start (0 minute) to end of exercise (60 minutes) were analyzed using a mixed-effect model. The model included treatment (Lyumjev with 50% basal reduction, Lyumjev with 100% basal reduction, Humalog with 50% basal reduction, and Humalog with 100% basal reduction), sequence, period, timepoint, treatment-by-timepoint interaction as fixed effects, and participant-within-sequence as a random effect.
Outcome measures
| Measure |
Lyumjev With 50% Basal Rate Reduction
n=25 Participants
Participants from all the randomly assigned treatment sequence who received, Lyumjev with 50% basal rate reduction (treatment A), subcutaneously.
|
Lyumjev With 100% Basal Rate Reduction
n=25 Participants
Participants from all the randomly assigned treatment sequence who received, Lyumjev with 100% basal rate reduction (treatment B), subcutaneously.
|
Humalog With 50% Basal Rate Reduction
n=25 Participants
Participants from all the randomly assigned treatment sequence who received, Humalog with 50% basal rate reduction (treatment C), subcutaneously.
|
Humalog With 100% Basal Rate Reduction
n=25 Participants
Participants from all the randomly assigned treatment sequence who received, Humalog with 100% basal rate reduction (treatment D), subcutaneously.
|
|---|---|---|---|---|
|
Pharmacodynamics (PD): Change in Plasma Glucose (PG) From the Start to the End of Exercise
|
-26.8 milligram per Deciliter (mg/dL)
Standard Deviation 37.3
|
-46.9 milligram per Deciliter (mg/dL)
Standard Deviation 31.5
|
-39.0 milligram per Deciliter (mg/dL)
Standard Deviation 38.8
|
-60.5 milligram per Deciliter (mg/dL)
Standard Deviation 39.1
|
SECONDARY outcome
Timeframe: Baseline (0-hour time point prior of the MMTT), 4 hour post-meal MMTTPopulation: All participants who received at least one dose of study drug.
The outcome measure was analyzed using a mixed-effect model. The model included treatment (Lyumjev with 50% basal reduction, Lyumjev with 100% basal reduction, Humalog with 50% basal reduction, and Humalog with 100% basal reduction), sequence, and period as fixed effects, and participant-within-sequence will be included as a random effect.
Outcome measures
| Measure |
Lyumjev With 50% Basal Rate Reduction
n=25 Participants
Participants from all the randomly assigned treatment sequence who received, Lyumjev with 50% basal rate reduction (treatment A), subcutaneously.
|
Lyumjev With 100% Basal Rate Reduction
n=25 Participants
Participants from all the randomly assigned treatment sequence who received, Lyumjev with 100% basal rate reduction (treatment B), subcutaneously.
|
Humalog With 50% Basal Rate Reduction
n=25 Participants
Participants from all the randomly assigned treatment sequence who received, Humalog with 50% basal rate reduction (treatment C), subcutaneously.
|
Humalog With 100% Basal Rate Reduction
n=25 Participants
Participants from all the randomly assigned treatment sequence who received, Humalog with 100% basal rate reduction (treatment D), subcutaneously.
|
|---|---|---|---|---|
|
Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Versus Time Curve From Time 0 to 4 Hours [AUC(0-4)] of Postprandial Plasma Glucose (PPG) Post Mixed-Meal Tolerance Test (MMTT)
|
247 milligrams*hour per deciliter (mg*h/dL)
Standard Deviation 121
|
257 milligrams*hour per deciliter (mg*h/dL)
Standard Deviation 145
|
202 milligrams*hour per deciliter (mg*h/dL)
Standard Deviation 188
|
262 milligrams*hour per deciliter (mg*h/dL)
Standard Deviation 129
|
Adverse Events
Lyumjev With 50% Basal Rate Reduction
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Lyumjev With 100% Basal Rate Reduction
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Humalog With 50% Basal Rate Reduction
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Humalog With 100% Basal Rate Reduction
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lyumjev With 50% Basal Rate Reduction
n=25 participants at risk
Participants from all the randomly assigned treatment sequence who received, Lyumjev with 50% basal rate reduction (treatment A), subcutaneously.
|
Lyumjev With 100% Basal Rate Reduction
n=25 participants at risk
Participants from all the randomly assigned treatment sequence who received, Lyumjev with 100% basal rate reduction (treatment B), subcutaneously.
|
Humalog With 50% Basal Rate Reduction
n=25 participants at risk
Participants from all the randomly assigned treatment sequence who received, Humalog with 50% basal rate reduction (treatment C), subcutaneously.
|
Humalog With 100% Basal Rate Reduction
n=25 participants at risk
Participants from all the randomly assigned treatment sequence who received, Humalog with 100% basal rate reduction (treatment D), subcutaneously.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
4.0%
1/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
0.00%
0/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
4.0%
1/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
0.00%
0/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
4.0%
1/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
0.00%
0/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
4.0%
1/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
0.00%
0/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
4.0%
1/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
0.00%
0/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
0.00%
0/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
4.0%
1/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
0.00%
0/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
0.00%
0/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
4.0%
1/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
|
General disorders
Medical device site pain
|
0.00%
0/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
0.00%
0/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
0.00%
0/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
4.0%
1/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
4.0%
1/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
0.00%
0/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
0.00%
0/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
0.00%
0/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
4.0%
1/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
0.00%
0/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
4.0%
1/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
0.00%
0/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
0.00%
0/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
0.00%
0/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
0.00%
0/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
4.0%
1/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Tooth extraction
|
4.0%
1/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
0.00%
0/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
0.00%
0/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
0.00%
0/25 • Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60