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

NCT03659799 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-09-01

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Institut de Recherches Cliniques de Montreal

    lead OTHER

Principal Investigators

  • Remi Rabasa-Lhoret · Institut de recherches cliniques de Montréal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-12
Primary Completion
2022-12-31
Completion
2023-03-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03659799 on ClinicalTrials.gov