E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 18.1 |
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 | 18.1 |
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 20 weeks, to assess the effect of treatment with sitagliptin compared with placebo on A1C (2) to assess the safety and tolerability of sitagliptin |
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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 20 weeks to assess effect of treatment with
sitagliptin compared to placebo on (1) fasting plasma glucose (FPG) (2)
the proportion of patients requiring glycemic rescue (3) the proportion
of patients at goal (A1C <7.0%) (4) body mass index (BMI) (5) fasting
measures of beta cell function.
In pediatric patients (ages 10-17 years) with T2DM with inadequate
glycemic control, after 54 weeks to assess: (1) effect of treatment with
sitagliptin (change from baseline) and in the placebo group (change
from baseline) on A1C, FPG, the proportion of patients requiring
glycemic rescue therapy, BMI, fasting measures of beta cell function (2)
effect of treatment with sitagliptin on the proportion of patients at goal
(A1C <7.0%) |
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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) a) Patient should not have received treatment with any oral AHA during the 12 weeks prior to the Screening Visit/Visit 1. However, patients who have had no more than a total of 10 days of treatment with an oral AHA (i.e., metformin, sulfonylureas, meglitinides
or alpha-glucosidase inhibitors) during the 12 weeks prior to the Screening Visit/Visit 1 are
eligible. Note: For patients who have received treatment with an oral AHA for more than a
total of 10 days within the 12 weeks prior to the Screening Visit/Visit 1, therapy
should not be stopped (washed-off) to make them eligible for the study.
b) Is on a stable dose (variance in dose to be ≤15 % of total daily dose) of insulin
(without any other antihyperglycemic agents) for at least 12 weeks prior to Screening
Visit/Visit 1.
3) Patient has an A1C of ≥6.5% and ≤10.0%. Note: Patients on insulin should have an A1C ≥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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E.4 | Principal exclusion criteria |
1. 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
2. Patient has symptomatic hyperglycemia and/or moderate to large ketonuria requiring immediate initiation of antihyperglycemic therapy. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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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) |
Change from baseline in A1C at Week 54
Proportion of subjects with an A1C Goals (<7.0%, <6.5%) at Week 20
and Week 54
Change from baseline in fasting endpoints at Week 20 and Week 54:
Fasting Plasma glucose (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 | 2 |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 45 |
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 |
Argentina |
Austria |
Brazil |
Bulgaria |
Canada |
Chile |
China |
Colombia |
Costa Rica |
Denmark |
Dominican Republic |
France |
Germany |
Guatemala |
Hong Kong |
Hungary |
Israel |
Italy |
Latvia |
Lithuania |
Malaysia |
Mexico |
Netherlands |
New Zealand |
Panama |
Philippines |
Poland |
Romania |
Russian Federation |
Saudi Arabia |
Serbia |
Slovakia |
Spain |
Sweden |
Thailand |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | |
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 |