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 | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012608 |
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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 primary objective of this trial is to compare the glycaemic control of once daily insulin detemir regimen with that of twice-daily insulin detemir regimen as measured by HbA1c in subjects with type 1 diabetes on a basal-bolus regimen with insulin aspart as bolus insulin after 4 months of treatment (including a one month run in period). |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives of this trial are to analyse the two-treatment regimen (insulin detemir once daily versus twice daily) after 4 months of the treatment according to the criteria listed below.
In addition, secondary objectives of this trial are to describe and analyse changes during the 3 months extension period within the two treatment groups:
At 4 months visit and at 7 months visit •Efficacy objectives •Safety objectives •Insulin dose requirements (absolute and related to weight) are evaluated. For further details please refer to the protocol section 4. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Informed Consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject), 2. Type 1 diabetes for more than 1 year, 3. Subject between 18 and 70 years old, 4. Subject treated by any kind of insulin regimen and whatever the number of injections, 5. Subjects regularly followed up by the Investigator for at least 6 months, 6. HbA1c ≥ 7.5% and ≤ 10% (dosage performed by a local laboratory within the last 3 months). |
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E.4 | Principal exclusion criteria |
1. Type 2 diabetes, 2. Treatment by OAD (within the last 6 months and/or during the study), 3. Proliferative retinopathy, 4. Hypoglycaemia unawareness as judged by investigator, 5. Impaired hepatic function, renal function or cardiac function as judged by investigator 6. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures as judged by the investigator, 7. History of alcoholism, drug abuse, or psychiatric disease or personality disorders likely to invalidate voluntary consent or to prevent good compliance with the trial protocol, 8. Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation, 9. Legal incapacity or limited legal capacity, 10. Participation in another clinical trial less than one month before inclusion in this trial, 11. Illness requiring repeated hospitalisation, 12. Known or suspected allergy to the insulin or any compositional component, 13. Subject receiving concomitant medication known to interfere with glucose metabolism (such as cortisteroids, β-blockers, thyroid hormones), 14. Any other condition that the Investigator feels would interfere with trial participation or evaluation of results. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Mean HbA1C after 4 months of insulin detemir treatment. |
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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 | Information not present in EudraCT |
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) | 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 | 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 | 0 |
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 years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |