DRKS00015855
Recruiting
Phase 4
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-ExFiasp®
Forschungseinheit für interdisziplinäre metabolische Medizin, Medizinische Universität Graz0 sites44 target enrollmentJune 12, 2019
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- E10
- Sponsor
- Forschungseinheit für interdisziplinäre metabolische Medizin, Medizinische Universität Graz
- Enrollment
- 44
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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