E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
cystic fibrosis patients without cystic fibrosis related diabetes |
cystic fibrosis zonder CF gerelateerde diabetes |
|
E.1.1.1 | Medical condition in easily understood language |
cystic fibrosis |
taaislijmziekte |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
investigate the effect of low dose insulin therapy on nutritional status en body weight,. |
Het effect van lage dosis langwerkend insuline onderzoeken op de voedingsstatus en lichaamsgewicht. |
|
E.2.2 | Secondary objectives of the trial |
investigate the effect of insulin on pulmonary function and quality of life. |
londerzoeken van het effect van insuline op ongfunktie en kwaliteit van leven. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients>18 years diagnosed with cystic fibrosis, a normal glucose tolerance test, exocrine pancreatic insufficiency. |
>18 jaar, diagnose CF, normale glucose tolerantie test, exocriene pancreas insufficientie. |
|
E.4 | Principal exclusion criteria |
pregnancy, pregnancy wish, lactation, history of organ transplantation, high urgency status on waiting list for transplantation, use of systemic corticosteroids within one mont before of during the study period, malignancy, distal intestinal obstruction syndrome (DIOS) or pulmonary exacerbation with hospital admission one month before or during the study period, use of appetite stimulants. |
zwangerschap(swens), borstvoeding, transplantatie in voorgeschiedenis, HU status op wachtlijst, gebruik van systemische steroiden 1 maand voor of tijdens studie, DIOS, maligniteit, exacerbatie CF 1 maand voor of tijdens de studie, gebruik van eetlust bevorderende medicamenten. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
body weight, body mass index |
lichaamsgewicht, BMI |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
end of study period ( 24 weeks) |
einde studie periode (24 wk) |
|
E.5.2 | Secondary end point(s) |
pre-albumin levels, vitamin status, pulmonary function, number of exacerbations, antibiotic use, Fat free mass index. ESR, CRP, leucocytes, quality of life on a validated quality of life questionnaire for CF. |
pre albumine, vitamine status, BSE, Leucocyten getal, CRP, longfunktie, aantal exacerbaties, antibiotica gebruik, vet vrije massa, kwaliteit van leven. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
end of study period ( 24 weeks) |
einde studie periode (24 wk) |
|
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 | 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 | 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) | 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 | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
|
|
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 | 6 |
E.8.9.1 | In the Member State concerned days | |