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Lyumjev ® (insulin lispro - aabc) injection
100 units/mL, 200 units/mL
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Does Lyumjev® (insulin lispro-aabc) protect against exercise-associated hypoglycemia in adults with type 1 diabetes on standard continuous subcutaneous insulin infusion therapy?
In the study, significantly (p<.05) less hypoglycemic events were observed in the Lyumjev treatment group compared with the Humalog® (insulin lispro injection) treatment group during the exercise period for both basal rate reduction approaches.
Background
Individuals with type 1 diabetes (T1D) on continuous subcutaneous insulin infusion (CSII) have typically a large reduction in blood glucose (BG) levels during aerobic exercise, even when an insulin basal rate reduction (BRR) occurs at or before the onset of exercise.1
Study Purpose
The aim of this study was to assess if using Lyumjev 100 units/mL resulted in less exercise-induced glucose lowering compared with Humalog® (insulin lispro injection) 100 units/mL with 2 different BRR approaches during CSII therapy in patients with T1D.1
Study Design
This was a double-blind, 4-period crossover randomized, controlled trial in adults with T1D on standard CSII to evaluate Lyumjev 100 units/mL compared with Humalog 100 units/mL during either a 50% BRR started 60 minutes or a 100% BRR started 15 minutes prior to the onset of aerobic exercise.1
Primary endpoint was the change in glucose during exercise.1
Physically active patients (maximal oxygen consumption [VO2max]) =41.6±7.21 mL/kg/min) underwent basal/bolus optimization with Humalog prior to randomization.1
Each period, exercise on treadmill (walking for 60 minutes ie, ~55% VO2max) was performed 4 hours after a standardized meal at lunch with their usual prandial insulin dose.1
Study Results
Twenty-five participants (52% male) with a mean ± SD age of 36.7±10.3 years had a glycated hemoglobin (HbA1c) level of 6.76±0.78%. at baseline.1
Plasma Glucose Values
In the study, similar mean plasma glucose levels prior to the exercise onset were shown between Lyumjev and Humalog treatment groups (Basal and Change in Plasma Glucose Level in mg/dL Before and After Exercise in Patients With Type 1 Diabetes on Continuous Subcutaneous Insulin Infusion).1
Independent of the BRR, significantly (p<.05) less pronounced exercise-induced glucose lowering was shown in the Lyumjev treatment group compared with the Humalog treatment group (Basal and Change in Plasma Glucose Level in mg/dL Before and After Exercise in Patients With Type 1 Diabetes on Continuous Subcutaneous Insulin Infusion).1
Parametera |
Lyumjev |
Humalog |
50% BRR |
||
Basal PG after exercise |
154.8 (7.74) |
171.0 (6.84) |
Change in PG at the end of exercise from baseline |
-27.0 (7.38)b |
-39.6 (7.74) |
100% BRR |
||
PG after exercise |
165.6 (8.46) |
162.0 (7.56) |
Change in PG at the end of exercise from baseline |
-46.8 (6.30)b |
-61.2 (7.92) |
Abbreviations: BRR = basal rate reduction; Humalog = Humalog® (insulin lispro injection) 100 units/mL; Lyumjev = Lyumjev® (insulin lispro-aabc) 100 units/mL; PG = plasma glucose.
aData presented as mean (SD) unless otherwise indicated.
bp<.05 compared with Humalog treatment group.
During the 60 minutes of exercise in both BRR conditions, exercise-induced plasma glucose lowering was less pronounced with the Lyumjev treatment group compared with the Humalog treatment group (Mean Change in the Plasma Glucose Concentration From Baseline Versus Time During 50% or 100% BRR in Patients With T1D on CSII Treated With Lyumjev and Humalog).1
Figure 1 description: Exercise-induced plasma glucose lowering was significantly (p<.05) less pronounced in the Lyumjev treatment group compared with the Humalog treatment group, independent of basal rate reduction.
Abbreviations: BRR = basal rate reduction; CSII = continuous subcutaneous insulin infusion; Humalog = Humalog® (insulin lispro injection) 100 units/mL; Lyumjev = Lyumjev® (insulin lispro-aabc) 100 units/mL; T1D = type 1 diabetes.
Note: The error bar represented the standard error.
Hypoglycemic Events
In the study, significantly (p<.05) less hypoglycemic events were observed in the Lyumjev treatment group (12%) compared with the Humalog treatment group (32%) during the exercise period for both BRR approaches (Number of Participants Who Terminated the Exercise Test and Experienced Hypoglycemic Event (Plasma Glucose <70 mg/dL)).1
|
50% BRR |
100% BRR |
Overall |
Lyumjev |
1 (4%) |
2 (8%) |
12%a |
Humalog |
1 (4%) |
7 (28%) |
32% |
Abbreviations: BRR = basal rate reduction; Humalog = Humalog® (insulin lispro injection) 100 units/mL; Lyumjev = Lyumjev® (insulin lispro-aabc) 100 units/mL.
ap<.05 compared with Humalog treatment group.
Enclosed Prescribing Information
Reference
1Leohr J, Abibol AD, LaBell ES, et al. Ultra-rapid lispro is more protective against exercise-associated hypoglycaemia over lispro in adults with type 1 diabetes on continuous subcutaneous insulin infusion. Abstract presented at: 59th European Association for Study of Diabetes (EASD) Scientific Sessions; October 2-6, 2023; Hamburg, Germany.
Date of Last Review: September 27, 2023