E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers (Type 2. diabetes mellitus). |
2. tüüpi diabeet |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10012602 |
E.1.2 | Term | Diabetes mellitus (incl subtypes) |
E.1.2 | System Organ Class | 100000004860 |
|
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 main objective of the trial is to compare the insulinogenic effect of liraglutide after acute and chronic (21 days) administration. |
Uuringu peamiseks eesmärgiks on võrrelda liraglutiidi insulinogeenset toimet pärast akuutset ja kroonilist (21 päeva ) manustamist. |
|
E.2.2 | Secondary objectives of the trial |
Secondary objective of the trial is to investigate the effects of liraglutide on adrenal hormones. |
Lisaks jälgitakse ravimi toimel tekkivaid muutusi neerupealise hormoonide tasemetes kroonilisel ja akuutsel ravimi manustamisel. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Age 18-50 years 2) Bodyweight 50-100 kg
|
1) Vanus 18-50 aastat 2) Kehamass 50-100 kg |
|
E.4 | Principal exclusion criteria |
1) Existence of chronic diseases 2) Existence of drugs used daily 3) Pregnancy, lactation 4) Glucose plasma level (fasting state) ≥6,0 mmol/L |
1) Krooniliste haiguste olemasolu 2) Igapäevaselt tarvitatavate ravimite olemasolu 3) Rasedus, imetamine 4) Paastuglükoosi väärtus ≥6,0 mmol/L
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change in the glucose-sensitivity of the beta cells. Graded glucose infusion test will be used to create insulin secretion rate- plasma glucose curve. The primary end-point is the change of the slope of the curve from baseline after acute administration of liraglutide compared to the repeated administration (after 3-weeks of treatment). ISR is calculated using C-peptide levels. |
Kõhunäärme beetarakkude glükoositundlikuse muutus liraglutiidi akuutsel manustamisel võrreldes ravimi kroonlise manustamisega. Beetarkkdue isnuliinitundlikkus leitakse GGI-testi (graded glucose infusion test) tulemuste põhjal, vastandades Insuliini sekretsiooni määr (Insulin secretion rate, ISR) sellele vastava glükoosi kontsentratsioonile ning leides saadud kõvera tõusunurk. ISR leitakse C-peptiidi kontsentratsioonide alusel vastavalt varem kirjeldatud valemeile |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
baseline, after 1st dose of liraglutide , after 21 days treatment with liraglutide. |
ravita, pärast esimest liraglutiidi annust, pärast 21 päevast ravi liraglutiidiga. |
|
E.5.2 | Secondary end point(s) |
Other indicators for insulin secretion and hormonal parameters (renin, aldosterone, ACTH, cortisol) which are compared in acute and chronic liraglutide administration setting.
|
Teised insuliini sekretsiooni iseloomustavad näitajad ja hormonaalsed parameetrid (reniin, aldosteroon, adrenokortikotroopne hormoon, kortisool), mida võrreldaks liraglutiidi akuutsel ja kroonilisel manustamisel. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Same as timepoints of evaluation of primary endpoints. |
Samad mis esmaste tulemusnäitajata hindamiseks. |
|
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 | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | No |
E.8.1.1 | Randomised | No |
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 | No |
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 | No |
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 | 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
|
The end of the trial is defined as the last visit of the last subject undergoing the trial. |
Viimase uuritava uuringu läbimine. |
|
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |