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Type 1 Diabetes MellitusPhase 4NCT03659799

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

A Phase 4 study testing Insulin FiAsp, Insulin Aspart and 60-minutes postprandial exercise in people with Type 1 Diabetes Mellitus, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Insulin FiAsp, Insulin Aspart and 60-minutes postprandial exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCanada
Study dates
12 Apr 2019to 30 Mar 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females ≥ 18 years of old.
  • Clinical diagnosis of type 1 diabetes for at least one year.
  • HbA1c ≤ 9.5%.
  • Patients using multiple daily injections with basal-bolus insulin regimen and insulin analogs (pre-meal: Aspart, Lispro, Guilisine or Fiasp; basal: Detemir, Glargine U100 \& U300, Degludec U100).
  • Written informed consent given.

Who cannot join

  • Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
  • Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  • Anemia (Hb < 100g/L).
  • Ongoing pregnancy or breastfeeding.
  • Severe hypoglycemic episode within two weeks of screening.
  • Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
  • Ongoing treatment with CSII (Continuous Subcutaneous Insulin Infusion) "insulin pump therapy".
  • Participation to a clinical trial in the last 3 months prior to inclusion in this study.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Institut de recherches cliniques de Montréal

    Montreal, Quebec, H2W 1R7

Other trials in Canada

About this study

Official title: 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

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.

Read more

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.

Being tested
Insulin FiAsp, Insulin Aspart, 60-minutes postprandial exercise, 120-minutes postprandial exercise
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin FiAspDrug

    An insulin bolus of FiAsp will be given 5 minutes before breakfast

  • Insulin AspartDrug

    An insulin bolus of Aspart will be given 5 minutes before breakfast

  • 60-minutes postprandial exerciseOther

    A 60-minute exercise at 60% of VO2 peak will be performed 60 minutes after breakfast

  • 120-minutes postprandial exerciseOther

    A 60-minute exercise at 60% of VO2 peak will be performed 120 minutes after breakfast

Study groups in NCT03659799
Study groupRoleWhat they receive
Aspart - 60-minutes postprandial exerciseActive comparatorNot described
Receives: Drug: Insulin Aspart; Other: 60-minutes postprandial exercise
Aspart - 120-minutes postprandial exerciseActive comparatorNot described
Receives: Drug: Insulin Aspart; Other: 120-minutes postprandial exercise
FiAsp - 60-minutes postprandial exerciseActive comparatorNot described
Receives: Drug: Insulin FiAsp; Other: 60-minutes postprandial exercise
FiAsp - 120-minutes postprandial exerciseActive comparatorNot described
Receives: Drug: Insulin FiAsp; Other: 120-minutes postprandial exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Decrease in plasma glucose levels during exercise

    Difference between glucose levels at the beginning of the exercise and the lowest glucose levels from the start of the exercise until the end of the exercise

    Measured: 60 minutes (exercise period)

Secondary outcomes (24)

  1. Percentage of time of plasma glucose levels spent below 4 mmol/L

    Measured: 60 minutes (exercise period)

  2. Decremental area under the curve of plasma glucose levels

    Measured: 60 minutes (exercise period)

  3. Area under the curve of plasma glucose levels below 4 mmol/L

    Measured: 60 minutes (exercise period)

  4. Number of patients with an exercise-induced hypoglycemia below 3.9 mmol/L

    Measured: 60 minutes (exercise period)

  5. Number of patients with an exercise-induced hypoglycemia below 3.3 mmol/L

    Measured: 60 minutes (exercise period)

  6. Number of patients requiring an oral treatment for hypoglycemia

    Measured: 60 minutes (exercise period)

  7. Total number of hypoglycemia episodes requiring treatment

    Measured: 60 minutes (exercise period)

  8. Percentage of time of plasma glucose levels spent above 10 mmol/L

    Measured: 60 minutes (exercise period)

  9. Percentage of time of plasma glucose levels spent between 4 and 10 mmol/L

    Measured: 60 minutes (exercise period)

  10. Mean time (minutes) to the first hypoglycemic event

    Measured: 60 minutes (exercise period)

  11. Amount of carbohydrates needed to treat a hypoglycemic event

    Measured: 60 minutes (exercise period)

  12. Change in oxyhemoglobin in the vastus lateralis

    Measured: 60 minutes (exercise period)

  13. Changes in deoxyhemoglobin in the vastus lateralis

    Measured: 60 minutes (exercise period)

  14. Changes in total hemoglobin in the vastus lateralis

    Measured: 60 minutes (exercise period)

  15. Percentage of time of plasma glucose levels spent between 4 and 10 mmol/L

    Measured: 90 minutes after the end of exercise

  16. Percentage of time of plasma glucose levels spent below 4 mmol/L

    Measured: 90 minutes after the end of exercise

  17. Percentage of time of plasma glucose levels spent above 10 mmol/L

    Measured: 90 minutes after the end of exercise

  18. Area under the curve of plasma glucose levels below 4 mmol/L

    Measured: 90 minutes after the end of exercise

  19. Number of patients requiring an oral treatment for hypoglycemia

    Measured: 90 minutes after the end of exercise

  20. Total number of hypoglycemia episodes requiring treatment

    Measured: 90 minutes after the end of exercise

  21. Total amount of carbohydrates needed to treat hypoglycemic events

    Measured: 90 minutes after the end of exercise

  22. Area under the curve of plasma glucose levels

    Measured: 4.5 hours (entire protocol period)

  23. Total number of hypoglycemia episodes requiring treatment

    Measured: 4.5 hours (entire protocol period)

  24. Total amount of carbohydrates needed to treat hypoglycemic events

    Measured: 4.5 hours (entire protocol period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2018
  2. Study start12 Apr 2019
  3. Primary completion31 Dec 2022
  4. Study completion30 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03659799
Sponsor's protocol ID
FiAsp-Exercise
Status last verified
Mar 2022
First submitted
4 Sep 2018
Last updated
1 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Molveau J, Myette-Cote E, Tagougui S, Taleb N, St-Amand R, Suppere C, Bourdeau V, Heyman E, Rabasa-Lhoret R. Assessing the influence of insulin type (ultra-rapid vs rapid insulin) and exercise timing on postprandial exercise-induced hypoglycaemia risk in individuals with type 1 diabetes: a randomised controlled trial. Diabetologia. 2024 Nov;67(11):2408-2419. doi: 10.1007/s00125-024-06234-0. Epub 2024 Jul 29.

    PubMed 39069599

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Insulin FiAsp, Insulin Aspart and 60-minutes postprandial exercise in people with Type 1 Diabetes Mellitus, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decrease in plasma glucose levels during exercise (time frame: 60 minutes (exercise period)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03659799, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023; AzTrials last refreshed its copy on 8 Nov 2026.

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