NCT03659799

Comparison of FiAsp and Aspart During Postprandial Exercise in Adults With Type 1 Diabetes

A Double-blind, Randomized, Cross-over Study to Compare the Impact of Rapid-acting Insulin Aspart and Faster Acting Aspart (FiAsp) on Glucose Excursion During Postprandial Exercise in Adults With Type 1 Diabetes

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Institut de Recherches Cliniques de Montreal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hypoglycemia is the main barrier for physical activity practice of patients with type 1 diabetes (T1D). For postprandial exercise, anticipation with meal insulin bolus reduction is the recommended method to reduce exercise-associated hypoglycemic risk. The impact of faster acting Aspart (FiAsp) pharmacokinetic on hypoglycemic risk has not yet been explored. This study will explore two different timings for exercise onset. Objective: To compare the impact of rapid-acting insulin Aspart and faster acting Aspart (FiAsp) on glucose reduction during exercise. Design: This study is a randomized, four-way, crossover study to compare the efficacy of 1) rapid-acting insulin Aspart, and 2) FiAsp on glucose reduction during an exercise performed 60 minutes or 120 minutes after breakfast. The insulin used and the timing of the exercise will be randomized. This project will be conducted at Institut de recherches cliniques de Montréal (IRCM, Montreal, Canada). Hypothesis: Faster acting Aspart (FiAsp) will be non-inferior to insulin Aspart for hypoglycemic risk.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Insulin FiAsp	An insulin bolus of FiAsp will be given 5 minutes before breakfast
DRUG	Insulin Aspart	An insulin bolus of Aspart will be given 5 minutes before breakfast
OTHER	60-minutes postprandial exercise	A 60-minute exercise at 60% of VO2 peak will be performed 60 minutes after breakfast
OTHER	120-minutes postprandial exercise	A 60-minute exercise at 60% of VO2 peak will be performed 120 minutes after breakfast

Timeline

• Start date: 2019-04-12
• Primary completion: 2022-12-31
• Completion: 2023-03-30
• First posted: 2018-09-06
• Last updated: 2023-09-01

Locations

1 site across 1 country: Canada