E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012601 |
E.1.2 | Term | Diabetes mellitus |
|
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 |
• At sammenligne reaktioner ved applikationssted efter superficielle subkutane og dybe subkutane injektioner med insulin detemir vurderet ved hjælp af Laser-Doppler blodgennemstrømningsanalyse ved besøg 3. |
|
E.2.2 | Secondary objectives of the trial |
• At sammenligne reaktioner ved applikationssted efter superficielle subkutane og dybe subkutane injektioner med insulin detemir vurderet ved hjælp af Laser-Doppler blodgennemstrømningsanalyse ved besøg 2 and 4.
• At sammenligne reaktioner ved applikationssted efter superficielle subkutane og dybe subkutane injektioner med insulin detemir vurderet som kliniske tegn og symptomer ved injektionsstederne.
• At undersøge udviklingen af detemir-specifikke og krydsreagerende antistoffer
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Informeret samtykke indhentes inden nogen form for forsøgsrelaterede aktiviteter påbegyndes. 2. Type 1 diabetes mellitus eller insulin-behandlet type 2 diabetes mellitus 3. Kaukasisk 4. Klinisk normalt udseende hud på lårene 5. Total daglig basal insulindosis > 20IE 6. Alder > 18 og < 60 år 7. BMI > 20,0 og < 35,0 kg/m2 8. HbA1c < 11,0% 9. Insulin detemir naiv |
|
E.4 | Principal exclusion criteria |
1. Kendt eller mistanke om allergi over for forsøgsprodukter 2. Tidligere deltagelse i dette forsøg 3. Fertile kvinder, som er gravide, ammer eller planlægger at blive gravide, eller som ikke anvender tilstrækkelig prævention (p-piller, spiral eller depot gestagen) 4. Igangværende steroid-behandling 5. Igangværende antihistamin-behandling 6. Ikke i stand til eller uvillig til at fastholde insulin-regime i hele forsøgsperioden. 7. Ekstensiv lipodystrofi på lårene 8. Ændringer i insulintype inden for de sidste 30 dage forud for screening 9. Ændring i antihypertensiv behandling inden for de sidste 14 dage forud for screening 10. Modtagelse af anden forsøgmedicin inden de sidste 30 dage forud for screening 11. Rygere eller i behandling med nikotinholdige stoffer til rygeophør 12. Alkohol- eller stofmisbrugere
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
• Laser-Doppler vurdering af blodgennemstrømning ved injektionsstederne
• Kliniske tegn og symptomer ved injektionsstederne (i henhold til ESCD-retningslinjer)
• Insulin detemir specifikke antistoffer
• Uønskede hændelser
|
|
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 | 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 |
mekanisme bag kutane reaktioner |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
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) | 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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
patienten er sin egen kontrol |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | Information not present in EudraCT |
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
|
Last visit of last subject |
|
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 | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |