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 | Body processes [G] - Immune system processes [G12] |
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 |
Difference in mean time in euglycemia 24 hours after exercise |
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E.2.2 | Secondary objectives of the trial |
DiffInflammation: Difference in IL-6 in comparison over time within the group/between groups
FGMacc: Accuracy of interstitial glucose compared to blood glucose from 0 to 45 min during CE.
BGdeltalowex: Blood glucose decrease during exercise to lowest glucose concentration from 0 to 45 min
BGmeanex: Mean blood glucose from 0 to 45 min during exercise
BG45minex: Blood glucose concentration after 45 min of exercise
BGdeltaex: Difference in blood glucose concentration from immediate pre-exercise until 45 minutes of exercise
BGmin: Minimum blood glucose concentration during exercise from 0 to 45 min
Hypoex: Numbers of confirmed hypoglycemic episodes during exercise (< 4.4 mmol.l-1)
CHO/INSpostex: Number/amount of carbohydrate and insulin administrations given during exercise from 0 to 45 min in response to hypo- or hyperglycemia |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Type 1 Diabetes
2) Aged: 18 – 65 years (both inclusive)
3) A1c 7 - 9% (53 – 75 mmol.mol-1) (both inclusive)
4) Fasting c-peptide < 0.25 nmol.l-1 [21]
5) Intensified insulin therapy
6) Diabetes diagnosed > 12 months
7) BMI 18.5 – 27 kg/m2 (both inclusive)
8) more 150 min per week exercising with moderate intensity or more than 75 min per week exercising with high intensity |
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E.4 | Principal exclusion criteria |
1) Diabetic long-term complications
2) Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
3) Illness or disease, that confound the study results
4) Interference with insulin action
5) Suspected allergy to trial products
6) Addiction to alcohol
7) Use of drugs
8) Mental incapacity |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
100% degludec dose versus 75% degludec (reduced dose) |
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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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |