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 - NN-Ex-Fiasp

Medical University of Graz0 sites44 target enrollmentMay 10, 2019

ConditionsType 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]

DrugsFast-acting insulin aspart (Fiasp® 100 U/mL) in 3 mL FlexTouch®Insulin aspart (NovoRapid® 100 U/mL) in 3 mL FlexPen®Insulin degludec (Tresiba® 100 U/mL) in 3 mL FlexTouch®

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Type 1 Diabetes
Sponsor: Medical University of Graz
Enrollment: 44
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 10, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Medical University of Graz

Eligibility Criteria

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

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