NCT03659799

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2019

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

April 12, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

September 1, 2023

Status Verified

March 1, 2022

Enrollment Period

3.7 years

First QC Date

September 4, 2018

Last Update Submit

August 31, 2023

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (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

    60 minutes (exercise period)

Secondary Outcomes (24)

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

    60 minutes (exercise period)

  • Decremental area under the curve of plasma glucose levels

    60 minutes (exercise period)

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

    60 minutes (exercise period)

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

    60 minutes (exercise period)

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

    60 minutes (exercise period)

  • +19 more secondary outcomes

Study Arms (4)

Aspart - 60-minutes postprandial exercise

ACTIVE COMPARATOR
Drug: Insulin AspartOther: 60-minutes postprandial exercise

Aspart - 120-minutes postprandial exercise

ACTIVE COMPARATOR
Drug: Insulin AspartOther: 120-minutes postprandial exercise

FiAsp - 60-minutes postprandial exercise

ACTIVE COMPARATOR
Drug: Insulin FiAspOther: 60-minutes postprandial exercise

FiAsp - 120-minutes postprandial exercise

ACTIVE COMPARATOR
Drug: Insulin FiAspOther: 120-minutes postprandial exercise

Interventions

Insulin FiAspDRUG

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

FiAsp - 120-minutes postprandial exerciseFiAsp - 60-minutes postprandial exercise
Insulin AspartDRUG

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

Aspart - 120-minutes postprandial exerciseAspart - 60-minutes postprandial exercise
60-minutes postprandial exerciseOTHER

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

Aspart - 60-minutes postprandial exerciseFiAsp - 60-minutes postprandial exercise
120-minutes postprandial exerciseOTHER

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

Aspart - 120-minutes postprandial exerciseFiAsp - 120-minutes postprandial exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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".

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W 1R7, Canada

Location

Related Publications (1)

  • 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.

    PMID: 39069599DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Remi Rabasa-Lhoret

    Institut de recherches cliniques de Montréal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2018

First Posted

September 6, 2018

Study Start

April 12, 2019

Primary Completion

December 31, 2022

Study Completion

March 30, 2023

Last Updated

September 1, 2023

Record last verified: 2022-03

Locations

CA(1)