Type 1 diabetes

Evaluation of Insulin Lispro Pharmacokinetics and Pharmacodynamics Over 10 Days of Continuous Insulin Infusion in People With Type 1 Diabetes

J Diabetes Sci TechnolPublished Randomised controlled trial

Primary result · Days 7 and 10Result — go to the resultCIns.max lower with LY900027 ≈14%-23%

Authors' conclusion

The pharmacokinetics of insulin changed over catheter wear time even when an anti-inflammatory agent was present. Postprandial glycemic control was adversely affected by the accelerated insulin absorption and decreased insulin exposure.

Study context

Population
Adults with T1D for ≥1 year on stable continuous subcutaneous insulin infusion (CSII) for ≥3 monthsrandomized
Participants
20 adults
Comparison
LY900027 vs insulin lispro over 10 days of CSII at one site
Primary endpoint
AUC of insulin lispro 0–5 h (AUCIns.0-5h) after bolus before MMTT and maximum observed insulin lispro concentration (CIns.max) on days 5, 7 and 10 vs day 3 (baseline)
Follow-up
Days 5, 7 and 10 vs day 3
Methodological detailsphase 1, double-blind, single-centre, two-way crossover
  • Phase 1
  • Double-blind
  • Single-centre
  • Two-way crossover

Primary result

Days 7 and 10

CIns.max lower with LY900027

≈14%-23%

P ≤ 0.0805

As reported in the abstract

AUCIns.0-5h change day 10 vs day 3, LY900027
−19%
AUCIns.0-5h change day 10 vs day 3, insulin lispro
−14%
CIns.max increase days 5, 7, 10 vs day 3, LY900027
≈14%-23%
CIns.max increase days 5, 7, 10 vs day 3, insulin lispro
≈16%-51%

Further findings

Insulin absorption accelerated with both treatments from days 1 to 7
Accelerated absorption and modest loss of total insulin exposure led to loss of mixed-meal tolerance test (MMTT) glycaemic control at later time points

Original publication

Evaluation of Insulin Lispro Pharmacokinetics and Pharmacodynamics Over 10 Days of Continuous Insulin Infusion in People With Type 1 Diabetes. J Diabetes Sci Technol. Published 28 December 2022. doi:10.1177/19322968221145200

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