A trial investigating the effect on blood glucose after the injection of fast-acting insulin aspart (Fiasp®) in comparison to insulin aspart (NovoRapid®) around exercise in participants with type 1 diabetes

Phase 4

Recruiting

• Conditions: E10; Type 1 diabetes mellitus

• Registration Number: DRKS00015855
• Lead Sponsor: Forschungseinheit für interdisziplinäre metabolische Medizin, Medizinische Universität Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

•Male or female aged 18-65 years (both inclusive).
•Type 1 diabetes mellitus = 12 months.
•Treated with multiple daily insulin injections =12 months.
•Body mass index 18.0-29.4 kg/m2 (both inclusive).
•Mass-specific VO2peak>20 ml/kg body weight/min.
•HbA1c=9.5 % (80 mmol/mol)

Exclusion Criteria

•Known or suspected hypersensitivity to trial product(s) or related products
•Receipt of any investigational medicinal product within 1 month prior to screening in this trial
•Known haemoglobin <8.0 mmol/L (male) or < 6.4 mmol/L (female), total leukocyte count < 3.0 x 109/L, thrombocytes <100 x 109/L, serum creatinine levels = 126 µmol/L (male) or = 111 µmol/L (female), alanine aminotransferase > 2 x the upper limit of normal (ULN), bilirubin > 3 x ULN, alkaline phosphatase > 2 x ULN
•Suffer from or history of a life-threatening disease (i.e. cancer judged not to be in full remission except basal cell skin cancer or squamous cell skin cancer), or clinically severe diseases that directly influence the study results, as judged by the Investigator. This does not prohibit the participation of patients taking medications that influences the metabolism (e.g. statin) or cardio-respiratory system (e.g. asthma spray, ACE-inhibitors) as long as the therapy is stable and is not adapted throughout the run of the trial. Furthermore, it does not exclude patients who have celiac disease (or similar diseases or allergies), as long as the disease is stable, and patients are able to stay on their specific (e.g.) gluten-free diet.
•Participant with a heart rate < 40 beats per minute (bpm) at screening (after resting for 5 min in supine position)
•Cardiac problems defined as decompensated heart failure (New York Heart Association (NYHA) class III and IV) 10 at any time and/or angina pectoris within the last 12 months and/or acute myocardial infarction at any time
•Supine blood pressure at screening (after resting for 5 min in supine position) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic (excluding white-coat hypertension; therefore, if a repeated measurement on a second screening visit shows values within the range, the participant can be included in the trial). This exclusion criterion also pertains to participants being on antihypertensives (as long as the blood pressure is within the range, participants on hypertensives can be included)
•Clinically significant abnormal ECG at screening, as judged by the Investigator
•Proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator
•Any chronic disorder or severe disease which, in the opinion of the Investigator might jeopardize participant’s safety or compliance with the protocol
•Participant known to be positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies (or diagnosed with active hepatitis), for HIV-1 antibodies, HIV-2 antibodies or HIV-1 antigen
•History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction (except celiac disease – patient must exclude foods that contain gluten from the diet)
•Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to screening
•Current treatment with systemic (oral or i.v.) corticosteroids, monoamine oxidase (MAO) inhibitors, non-selective or selective beta-blockers, growth hormone, herbal products or non-routine vitamins. Furthermore, thyroid hormones are not allowed unless the use of these has been stable during the past 3 months
•Significant history of alcoholism or drug/chemical abuse as per Investigator’s judgement.
•Smoker (defined as a participant who is smoking more than 5 cigarettes or the equivalent per day)
•Not able or willing to refrain

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare changes in blood glucose concentrations of insulin Fiasp® and insulin NovoRapid® for the same pre- and post-exercise dose reduction (for both 2 x 50% and 2 x 75% reduced short-acting insulin dose) during exercise in 44 patients with type 1 diabetes (T1D) in a randomised, single-centre, double blind, four-period cross-over, twice dose trial.