E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type II Diabetes Mellitus |
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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 | 20.1 |
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 and 54 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 therapy
Sub-Study Objective is to enhance the dental data collected from the visual oral examination (VOE) to support secondary objectives to summarize data on the change from baseline in measures of dentition at Week 20 and Week 54 |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
The purpose of this sub-study is to augment the visual oral examination (VOE) data currently being collected in the main study P083. New and ongoing patients (on or off study medication) participating in the main study, P083, will be asked to participate in this sub-study to collect supplemental dental data. |
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E.3 | Principal inclusion criteria |
1. Patient has type 2 diabetes mellitus (T2DM).
2. Patient has not treatment with an oral AHA for ≥12 weeks prior to the Screening Visit/Visit 1, or with insulin for at least 12 weeks prior to the Screening Visit/Visit 1.
3. Patient has an A1C of ≥6.5% and ≤10.0%.
Note: Patients on insulin have an A1C ≥7.0% and ≤10.0%.
4. Patient is 10 and 17 years of age 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.
6 .Sub-Study Inclusion Criteria: Patient was randomized into P083 and has taken at least one dose of study medication, including new and ongoing patients (on or off study medication), and patients who previously completed 54 weeks of the main study |
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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) |
Change from baseline in hemoglobin 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) |
Change from baseline 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) | Yes |
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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 16 |
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 |
Brazil |
Bulgaria |
Chile |
Colombia |
Costa Rica |
Dominican Republic |
Georgia |
Germany |
Greece |
Guatemala |
Honduras |
Hungary |
Israel |
Italy |
Latvia |
Lithuania |
Malaysia |
Mauritius |
Mexico |
Moldova, Republic of |
New Zealand |
Philippines |
Poland |
Romania |
Russian Federation |
Saudi Arabia |
Serbia |
Singapore |
Slovakia |
South Africa |
Spain |
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 | 6 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |
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 |
E.8.9.2 | In all countries concerned by the trial days | 0 |