E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 2 Diabetes Mellitus |
Diabetes Mellitus Typu 2 |
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E.1.1.1 | Medical condition in easily understood language |
Diabetes Type 2 |
Diabetes Typu 2 |
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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 | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012594 |
E.1.2 | Term | Diabetes |
E.1.2 | System Organ Class | 100000004861 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | Type II diabetes mellitus |
E.1.2 | System Organ Class | 100000004861 |
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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 |
In pediatric patients (ages 10-17 years) with T2DM with inadequate glycemic control: (1) after 16 weeks, to assess the effect of treatment with sitagliptin compared with placebo on A1C (2) to assess the safety and tolerability of sitagliptin |
U pediatrických pacientov (vo veku 10-17 rokov) s T2DM s neadekvátnou glykemickou kontrolou: 1. Po 16 týždňoch zhodnotiť účinok liečby sitagliptínom v porovnaní s placebom na A1C. 2. Zhodnotiť bezpečnosť a znášanlivosť sitagliptínu.
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E.2.2 | Secondary objectives of the trial |
In pediatric patients (ages 10-17 years) with T2DM with inadequate glycemic control, after 16 weeks (1) to assess the effect of treatment with sitagliptin compared with placebo on fasting plasma glucose (FPG) (2) to assess the effect of treatment with sitagliptin compared with placebo on the proportion of patients requiring glycemic rescue |
U pediatrických pacientov (vo veku 10-17 rokov) s T2DM s neadekvátnou glykemickou kontrolou po 16 týždňoch: 1. Zhodnotiť účinok liečby sitagliptínom v porovnaní s placebom na glukóze z plazmy nalačno (FPG). 2. Zhodnotiť účinok liečby sitagliptínom v porovnaní s placebom na pomernej časti pacientov, ktorí potrebujú záchrannú glykemickú liečbu.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Patient has type 2 diabetes mellitus (T2DM).
2) Patient should not have received treatment with an oral AHA for ≥12 weeks, or for ≥6 months with insulin, prior to the Screening Visit/Visit 1.
3) Patient has an A1C of ≥7.0% and ≤10.0%.
4) Patient is between 10 and 17 years of age (inclusive) on day of signing informed consent with randomization to occur prior to the patient’s 18th birthday.
5) Patient is either a male, or patient is a female who is unlikely to conceive, as indicated by at least one “yes” response to the following which will remain consistent for the projected duration of the study and for 14 days after the last dose of study medication:
a. Patient is a non-sterilized female who is currently not sexually active and agrees to follow statement "c" if heterosexual activity is initiated
or
b. Patient agrees to abstain from heterosexual activity
or
c. Patient agrees to use an adequate method of contraception.
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1.Pacient má T2DM
2. Pacient nedostával perorálnu liečbu AHA v období ≥ 12 týždňov, alebo inzulín po dobu ≥ 6 mesiacov pred skríningovou návštevou/1. návštevou
3. Pacient má A1C ≥ 7,0 % a ≤ 10,0 %.
4. Pacient je vo veku 10 až 17 rokov (vrátane) v deň podpísania informovamého súhlasu a randomizácia sa uskutoční pred 18. narodeninami pacienta.
5. Pacient je buď mužského, alebo ženského pohlavia, s nízkou pravdepodobnosťou splodenia, ako naznačuje aspoň jednou odpoveďou „áno“ na nasledovné, čo zostane konzistentné počas plánovaného obdobia skúšania a počas 14 dní po poslednej dávke skúšaného lieku:
a) Pacient je žena, ktorá nemá vykonanú sterilizáciu, ktorá nie je v súčasnosti sexuálne aktívna a súhlasí s dodržiavaním výhlásenia „c“, ak už začala s heterosexuálnou aktivitou,
alebo
b) pacient súhlasí so zdržiavaním sa od heterosexuálnej aktivity
alebo
c) Pacient súhlasí s používaním adekvátnej metódy antikoncepcie.
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E.4 | Principal exclusion criteria |
1. Patient has diabetes for >1 year.
2. Patient has (1) a history of type 1 diabetes mellitus, autoimmune diabetes mellitus or has a positive antibody screen for anti-GAD or ICA-512, or (2) known monogenic diabetes, secondary diabetes, or a genetic syndrome or disorder known to affect glucose tolerance other than diabetes
3. Patient has symptomatic hyperglycemia and/or moderate to large ketonuria requiring immediate initiation of antihyperglycemic therapy. |
1. Pacient má diabetes počas > 1 roka.
2. Pacient má anamnézu (1) diabetes mellitus 1. typu, autoimúnny diabetes mellitus alebo má pozitívny skrín na protilátky na anti-GAD alebo ICA-512 alebo (2) pacient má známy monogénny diabetes, sekundárny diabetes, alebo genetický syndróm alebo ochorenie, ktoré ovplyvňuje glukózovú toleranciu, iné ako diabetes
3. Pacient má symptomatickú hyperglykémiu a/alebo miernu alebo veľkú ketonúriu, ktorá si vyžaduje okamžité začatie antihyperglykemickej liečby. |
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E.5 End points |
E.5.1 | Primary end point(s) |
hemoglobin A1c (A1C) |
hemoglobín A1c (A1C) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
fasting plasma glucose (FPG) |
fasting plazma glukóza (FPG) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.5 | Efficacy | Yes |
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 | Yes |
E.6.11 | Pharmacogenomic | Yes |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 38 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 38 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Bulgaria |
Canada |
China |
Denmark |
France |
Italy |
Austria |
Netherlands |
New Zealand |
Romania |
Slovakia |
Sweden |
Dominican Republic |
Argentina |
Brazil |
Chile |
Colombia |
Costa Rica |
Germany |
Guatemala |
Hong Kong |
Hungary |
Latvia |
Lithuania |
Malaysia |
Saudi Arabia |
Spain |
Thailand |
Israel |
Mexico |
Panama |
Philippines |
Poland |
Russian Federation |
Serbia |
United Arab Emirates |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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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LVLS |
Posledná návšteva posledného pacienta |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 5 |