| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
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| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 8.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10045228 |
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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 |
| The objective of this study is to assess the impact of three basal insulin treatments on the maximum plasma glucose decline in people with Type 1 diabetes managed on a basal-bolus insulin regimen when performing physical exercise |
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| E.2.2 | Secondary objectives of the trial |
To compare the three basal insulin treatments in terms of;
•Plasma glucose profiles pre and post exercise
•Minimum plasma glucose value in the period 0-150 minutes post exercise (nadir)
•Serum bolus insulin concentration immediately prior to and post exercise
•Slope of Decline in plasma glucose post exercise
•Self measured plasma glucose post exercise and at defined time points prior following each exercise test (4-point profile)
•Counterregulatory hormone response
•Incidence of hypoglycaemic episodes (major and minor) during and post exercise
•Time between start of the exercise test and minimum plasma glucose value (first plasma glucose value <3.0mmol/l in case of hypoglycaemia)
•The requirement and frequency of carbohydrate treatment during and post exercise
•Incidence of adverse events
•Standard clinical and laboratory safety parameters
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| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria |
1. Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedures that would not have been performed during normal management of the subject)
2. Type 1 diabetes
3. Duration of type 1 diabetes ≥ 12 months
4. Current stable treatment: Basal-bolus insulin regimen ≥ 3 months with at least once daily injection of intermediate-acting insulin, long-acting insulin or long-acting insulin analogues, and fast-acting insulin with each main meal
5. Age ≥18 years
6. HbA1c ≤9.0% based on analysis from the central laboratory
7. BMI < 32.0 kg/m2
8. Able and willing to adhere to the trial-specific insulin regimen for the entire trial period
9. Able and willing to perform self-monitoring of plasma glucose according to the protocol
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| E.4 | Principal exclusion criteria |
1.Previous participation in this trial. Participation is defined as randomisation
2.Anticipated change in concomitant medication known to interfere with glucose metabolism such as systemic steroids or mono amine oxidase (MAO) inhibitors
3.Use of any medication affecting heart rate (e.g. beta blockers)
4.Proliferative retinopathy or maculopathy that has required acute treatment within the last six months
5.Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by Investigator
6.Physical disability which may make exercise difficult
7.Impaired hepatic function measured as alanine aminotransferase (ALAT) ≥four times the upper reference limit based on analysis from the central laboratory
8.Impaired renal function measured as creatinine ≥150 µmol/l (1.7 mg/dl) based on analysis from the central laboratory
9.Cardiac disease defined as unstable angina pectoris, myocardial infarction (MI) within the last 6 months or congestive heart failure NYHA class II to IV
10.Uncontrolled treated/untreated hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥ 100 mmHg)
11.Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation
12.Pregnancy, or the intention of becoming pregnant, breast feeding or judged not to be using adequate contraceptive measures. Adequate contraceptive methods are defined as sterilisation, IUD, oral contraceptives or consistent use of barrier methods
13.Known or suspected allergy to trial products or related products
14.Receipt of any investigational drug within one month prior to this trial
15.Current drug or alcohol abuse, known to the Investigator
16.Significant concomitant disease likely to interfere with the glucose metabolism, as judged by the Investigator
17.Any other condition that the Investigator feels would interfere with trial participation or evaluation of data
18. Abnormal, clinically significant findings on screening ECG.
Exercise Test Day Exclusion Criteria (visits 4, 6, 8)
1.Subject informs the site that they are unable to attend the clinic on the scheduled day
2.Unusually strenuous exercise (as judged by the Investigator and / or subject) within 72 hours prior to each exercise test
3.Consumption of alcohol within 24 hours prior to an exercise test
4.Intake of caffeine after midnight on the night prior to an exercise test
5.Subject not fasting post breakfast on an exercise test day
6.Injection of bolus insulin after breakfast on an exercise test day
7.Injection of basal insulin after breakfast on an exercise test day
8.Clinically significant (as judged by the Investigator) hypoglycaemic episodes in the 24 hours prior to the subject arriving at the site for an exercise test
9.Visit 6 and 8: Fasting PG value outside of the range ± 3.0 mmol/l compared with the value at visit 4
10.Visits 6 and 8: Carbohydrate intake during the three days prior to the exercise test is significantly different from that at previous exercise tests (as determined by the investigator)
11.Any condition that the Investigator feels may interfere with the ability to complete the exercise test, collection or evaluation of data
12. Clinically significant change in ECG on exercise test day, compared with screening ECG.
Subjects unable to complete their exercise test on the scheduled day will have their test postponed and rescheduled for up to 7 days later. Subjects may be rescheduled once per study arm and a maximum of twice for the duration of the study.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
| The difference between plasma glucose concentrations immediately pre-exercise and the minimum plasma glucose concentrations (nadir) in the period 0-150 min following exercise |
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | Information not present in EudraCT |
| E.6.2 | Prophylaxis | Information not present in EudraCT |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | No |
| E.6.5 | Efficacy | Information not present in EudraCT |
| E.6.6 | Pharmacokinetic | Information not present in EudraCT |
| E.6.7 | Pharmacodynamic | Information not present in EudraCT |
| E.6.8 | Bioequivalence | Information not present in EudraCT |
| E.6.9 | Dose response | Information not present in EudraCT |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | Information not present in EudraCT |
| E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
| E.6.13 | Others | Information not present in EudraCT |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
| E.7.1.1 | First administration to humans | Information not present in EudraCT |
| E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
| E.7.1.3 | Other | Information not present in EudraCT |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
| E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
| 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 | Information not present in EudraCT |
| E.8.1.3 | Single blind | Information not present in EudraCT |
| E.8.1.4 | Double blind | Information not present in EudraCT |
| E.8.1.5 | Parallel group | Information not present in EudraCT |
| E.8.1.6 | Cross over | Information not present in EudraCT |
| E.8.1.7 | Other | Information not present in EudraCT |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
| E.8.2.2 | Placebo | Information not present in EudraCT |
| E.8.2.3 | Other | Information not present in EudraCT |
| 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 | Information not present in EudraCT |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
| 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 | 9 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 9 |
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