A study that investigates the effects of fast-acting insulin (FIASP®) on blood sugars in comparison to a different fast-acting insulin (NovoRapid®) around exercise in participants with type 1 diabetes

Phase 1

• Conditions: Type 1 Diabetes; MedDRA version: 20.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2019-001281-14-AT
• Lead Sponsor: Medical University of Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-10
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 44

Inclusion Criteria

•Adults with type 1 diabetes mellitus (as diagnosed clinically) = 12 months
•Treated with multiple daily insulin injections = 12 months
•Body mass index 18.0-29.4 kg/m2 (both inclusive)
•Mass-specific peak oxygen consumption (VO2peak) >20 ml/kg/min
•HbA1c = 9.5 % (80 mmol/mol)
•C-peptide = 0.3 nmol/L

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Known or suspected hypersensitivity to trial product(s) or related products
•Receipt of any investigational medicinal product within 1 months prior to screening in this trial
•Haemoglobin <8.0 mmol/L (male) or < 6.4 mmol/L (female)
•Systemic (oral or i.v.) corticosteroids, monoamine oxidase (MAO) inhibitors, non-selective beta-blockers, growth hormone and non-routine vitamins and herbal products. Furthermore, thyroid hormones are not allowed unless the use of these has been stable during the past 3 months.
•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) as long as the therapy is stable and is not adapted throughout the run of the trial. Furthermore, it does not excluded patients how 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 anti-hypertensives
•Clinically significant abnormal ECG at screening, as judged by the Investigator
•Severe 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 jeopardise participant’s safety or compliance with the protocol
•History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
•Significant history of alcoholism or drug/chemical abuse as per Investigator’s judgement or a positive result in the urine drug/alcohol screen at the screening Visit.
•Smoker (defined as a participant who is smoking more than 5 cigarettes or the equivalent per day)
•Not able or willing to refrain from smoking, or use of nicotine substitute products during the inpatient period
•Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the past 12 months)
•Hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
•Participant with mental incapacity or language barriers precluding adequate understanding or cooperation or who, in th

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified