E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] |
MedDRA Classification |
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 |
Test whether micro-doses of glucagon at the site of subcutaneous CGM will reduce the sensing delay, i.e., the time it takes from a certain glucose level is present in the blood and until the same level is reflected in the level measured in subcutaneous interstitial tissue in patients with diabetes mellitus type 1. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria: 1. DM1 for at least one year 2. Age 18 – 75 years 3. Last HbA1c <86 mmol/l (< 10.0%) 4. Treated with insulin pump or multiple daily insulin injections (MDII)
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E.4 | Principal exclusion criteria |
Exclusion criteria: 1. Pregnant women or women trying to conceive 2. Any chronic disease, including major psychiatric diseases, judged incompatible with participation in the study 3. Medication with platelet inhibitor or antcoagulants 4. Clinically significant allergy to adhesives 5. Unfit for participation for any reason as judged by the investigators
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary outcome measure will be the time it takes for the CGM to measure a 1.0 mmol/L increase in glucose after the initiation of a meal. The glucagon treated CGM will be compared to the non-treated CGM in the same patient during the same meal. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Glucose sensing data is stored continuously by the CGM device. All data will be collected on the last study visit (maximum day 14). The end point will be evaluated at all the meals during the study period. |
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E.5.2 | Secondary end point(s) |
Secondary outcomes measures will be any deviation in glucose measurements when the glucagon treated CGM is compared to the control CGM in the same patient during the same meal. Among possible secondary outcome measures are maximum postprandial glucose level measured, time to maximum postprandial glucose level and area under the glucose curve the first 30, 60, 90 and 120 minutes after a meal. Possible differences in thermal camera and laser doppler flowmetry will also be studied.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Equal subcutaneous injected volume of 0.9% saline solution |
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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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
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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The trial is ended with 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 | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |