Type 1 Diabetes MedDRA version: 21.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen
Product Name: Toujeo
Product Code: A10AE04
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULI
Sponsors
Medical University of Graz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent obtained 2. Male or female aged 18-65 years (both inclusive) 3. Type 1 diabetes (as diagnosed clinically) = 12 months 4. Treated with multiple daily insulin injections = 12 months 5. Body mass index 18.0-29.9 kg/m2 (both inclusive) 6. Participants performing regular physical cardio-respiratory activity during the last 3 months prior to screening 7. HbA1c = 10% (86 mmol/mol) 8. Mass-specific peak oxygen consumption (VO2peak) >20 ml/kg/min 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 25 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known or suspected hypersensitivity to trial product(s) or related products 2. Receipt of any investigational medicinal product within 1 months prior to screening in this trial 3. Haemoglobin <8.0 mmol/L (12.9 mg/dl) (male) or < 6.8 mmol/L (11 mg/dl) (female) 4. 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. 5. 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. 6. Participant with a heart rate < 35 beats per minute (bpm) at screening (after resting for 5 min in supine position) 7. 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 8. Supine blood pressure at screening (after resting for 5 min in supine position) outside the range of 90-150 mmHg for systolic or 50-95 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 9. Clinically significant abnormal ECG at screening, as judged by the Investigator 10. Severe retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator 11. Any chronic disorder or severe disease which, in the opinion of the Investigator might jeopardise participant’s safety or compliance with the protocol 12. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction 13. 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. 14. Smoker (defined as a participant who is smoking more than 5 cigarettes or the equivalent per day) 15. Not able or willing to refrain from smoking, or use of nicotine substitute products during the inpatient period 16. Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the past 12 months) 17. Hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 12 months 18. Participant with mental incapacity or language barriers precluding adequate understanding or cooperation or who, in the opinion of their general practitioner or the Investigator, should not participate in the trial 19. Potentially non-compliant or uncooperative during the trial, as judged by the Investigator 20. Any condition that would interfere with
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare time spent in hypoglycaemia (= 3.0 mmol/L [=70?mg/dL]) for the 6 x 24-hour post-exercise period around multiple spontaneous exercise sessions (3 times per week spread over 2 weeks for each trial arm) on either a regular (100%) or 75% IGlar-U300 and IDeg-U100 dose ;Secondary Objective: •To compare numbers of hypoglycaemic event (= 3.9 mmol/L [= 70?mg/dL]) for the 6 x 24-hour post-exercise period around multiple spontaneous exercise sessions (3 times per week spread over 2 weeks for each trial arm) on either a regular (100%) or 75% IGlar-U300 and IDeg-U100 dose •To compare time spent in hypoglycaemia (= 3.0 mmol/L [=70?mg/dL]) for the 6 x 24-hour post-exercise period around multiple spontaneous exercise sessions (3 times per week spread over 2 weeks for each trial arm) on either a regular (100%) or 75% IGlar-U300 and IDeg-U100 dose stratified for day- (06.00 AM – 11.59 PM) and night-time (12.00 AM – 05.59 AM) and others ;Primary end point(s): •Time Hypoglycaemia (6x24 hrs post-exercise period): Time spent in hypoglycaemia (minutes, percentage of total time) for the 6 x 24-hour post-exercise period around multiple spontaneous exercise sessions (3 times per week spread over 2 weeks for each trial arm) on either a regular (100%) or 75% IGlar-U300 and IDeg-U100 dose;Timepoint(s) of evaluation of this end point: The timepoints of evaluation for the primary endpoint are the 24 hours following the spontaneous exercise sessions on either regular (100%) or 75% IGlar-U300 and IDeg-U100 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Time Hypoglycaemia (14 day-exercise period): Time spent in hypoglycaemia (minutes, percentage of total time) for the total 14-day-exercise period around multiple spontaneous exercise sessions (3 times per week spread over 2 weeks for each trial arm) on either a regular (100%) or 75% IGlar-U300 and IDeg-U100 dose • Time Hypoglycaemia (6x24 hrs post-exercise period): Time spent in hypoglycaemia (minutes, percentage of total time) for the 6 x 24-hour post-exercise period around multiple spontaneous exercise sessions (3 times per week spread over 2 weeks for each trial arm) on either a regular (100%) or 75% IGlar-U300 and IDeg-U100 dose stratified for day- (06.00 AM – 11.59 PM) and night-time (12.00 AM – 05.59 AM) • Time Hypoglycaemia (14 day-exercise period): Time spent in hypoglycaemia (minutes, percentage of total time) for the total 14-day-exercise period around multiple spontaneous exercise sessions (3 times per week spread over 2 weeks for each trial arm) on either a regular (100%) or 75% IGlar-U300 and IDeg-U100 dose stratified for day- (06.00 AM – 11.59 PM) and night-time (12.00 AM – 05.59 AM) • Numbers Hypoglycaemia (6x24 hrs post-exercise period): Numbers of hypoglycaemia (= 3.9 mmol/L [= 70?mg/dL]) for the 6 x 24-hour post-exercise period around multiple spontaneous exercise sessions (3 times per week spread over 2 weeks for each trial arm) on either a regular (100%) or 75% IGlar-U300 and IDeg-U100 dose • Numbers Hypoglycaemia (14 day-exercise period): Numbers of hypoglycaemia (= 3.9 mmol/L [= 70?mg/dL]) for the total 14-day-exercise period around multiple spontaneous exercise sessions (3 times per week spread over 2 weeks for each trial arm) on either a regular (100%) or 75% IGlar-U300 and IDeg-U100 dose • Time Glycaemic ranges (6x24 hrs post-exercise period): Time spent (minutes, percentage of total time) in prespecified glycaemic ranges (euglycaemia (4.0 - 9.9?mmol/L [71 - 179?mg/dL]), serious hypoglycaemia (= 2.9?mmol/L [= 53?mg/ | — |
Countries
Austria
Contacts
Public ContactDepartment of Internal Medicine
Medical University of Graz
Outcome results
None listed