E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetes Mellitus, Type 1 |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045228 |
E.1.2 | Term | Type I diabetes mellitus |
E.1.2 | System Organ Class | 100000004861 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To confirm the effect of continuous subcutaneous insulin infusion (CSII) treatment with faster-acting insulin aspart in terms of glycaemic control by comparing it to CSII treatment with NovoRapid®, in adults with Type 1 Diabetes Mellitus (T1DM), using a non-inferiority approach |
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E.2.2 | Secondary objectives of the trial |
To confirm superiority of CSII treatment with faster-acting insulin aspart compared to CSII treatment with NovoRapid® in adults with T1DM, in terms of:
- Postprandial glucose (PPG) regulation (meal test)
- Overall glycaemic control (HbA1c)
- Postprandial glucose excursions (1,5-anhydroglucitol)
- Time spent in low interstitial glucose (IG) (Continuous Glucose Monitoring (CGM))
To compare the effect and safety of CSII treatment with faster-acting insulin aspart vs CSII treatment with NovoRapid® in adults with T1DM |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female, age ≥18 years at the time of signing the informed consent
2. Diagnosed with T1DM ≥1 year prior to the day of screening
3. Using the same Medtronic pump (Minimed 530G (551/751), Paradigm Veo (554/754), Paradigm Revel (523/723), Paradigm (522/722)) for CSII in a basal-bolus regimen with a rapid acting insulin analogue for at least six months prior to screening and willing to stay on the same pump model throughout the trial (if the model is changed the change should not exceed 7 consecutive days.)
4. HbA1c 7.0-9.0% (53-75 mmol/mol) as assessed by central laboratory at screening
5. Body mass index (BMI) ≤ 35.0 kg/m^2 at screening
6. Ability and willingness to take at least 3 daily meal-time insulin bolus infusions every day throughout the trial
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E.4 | Principal exclusion criteria |
1. Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening
2. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
3. History of hospitalization for ketoacidosis ≤180 days prior to the day of screening
4. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening
5. Any condition which, in the opinion of the Investigator, might jeopardise a Subject’s safety or compliance with the protocol
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in glycosylated haemoglobin (HbA1c) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
16 weeks after randomisation |
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E.5.2 | Secondary end point(s) |
1. Change from baseline in 1-hour PPG increment (meal test)
2. Change from baseline in 1,5-anhydroglucitol
3. Change from baseline of time spent in low IG (≤3.9 mmol/L [70 mg/dL]) during CGM |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. + 2. + 3.: 16 weeks after randomisation |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 44 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
European Union |
Russian Federation |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 18 |