E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with type 2 diabetes |
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E.1.1.1 | Medical condition in easily understood language |
Patients with type 2 diabetes |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067585 |
E.1.2 | Term | Type 2 diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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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 |
To investigate the pharmacokinetics of Amaryl® in pediatric patients (8 to 16 years of age) with type 2 diabetes in comparison with adults patients (17 years or older of age) with type 2 diabetes under steady state |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy using change in HbA1C from baseline to last observation, and the safety in pediatric and adults patients with Amaryl® titrated to 80 - <130 mg/dL in FPG, 80 - <130 mg/dL in SMBG and/or <6.5% in HbA1C |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients who were diagnosed as type 2 diabetes and were treated with diet and exercise only for at least 2 weeks prior to enrollment
2. Pediatric patients aged 8 to 16 years or adult patients aged 17 years or older at the time of enrollment
3. Patients with a following condition at the time of enrollment
1) >=6.5% to <12.0% of HbA1C (a) in adult or pediatric patients; OR
2) Pediatric patients receiving =<2 mg/day of Amaryl®;
Note: The patient of 1) is more preferable than the patient of 2).
(a): The data at each site from -28 days to enrollment are available for enrollment data.
4. Patients who didn’t wish to be pregnant during the study medication period in case of female patients
5. Patients (20 years or older of age) who gave signed informed consent or patients (less than 20 years of age) as follows.
• 17 to 19 years
Patients who gave signed informed consent and whose parent[s] or legal guardian[s] gave signed informed consent
• 12 to 16 years
Patients whose parent[s] or legal guardian[s] gave signed informed consent and who gave signed informed assent
• 8 to 11 years
Patients whose parent[s] or legal guardian[s] gave signed informed consent and who gave signed or verbal informed assent. |
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E.4 | Principal exclusion criteria |
1. Patients who were diagnosed as Diabetes Mellitus other than type 2 diabetes
2. Patients who received insulin, insulin-like growth factor (IGF)-1 or an OHA other than Amaryl® within at least 8 weeks before enrollment
3. Adult patients who received Amaryl®
4. Patients with severe ketoacidosis, diabetic coma and/or precoma within 12 weeks before enrollment
5. Patients with liver function abnormality of AST or ALT (>2.5xULN)(b) (c)and/or renal function abnormality of Creatinine (>2.0 mg/dL)(c)
(b): In case of patients with fatty liver, patients with AST or ALT >3xULN were excluded
(c): The data at each site from -28 days to enrollment were available for enrollment data.
6. Patients with severe infection, pre-/post-surgery and/or severe trauma
7. Patients with gastrointestinal disorders such as diarrhea and/or vomiting
8. Female patients who are pregnant or possibly pregnant and/or lactating [Female patients (excluded female patients before menarche or after menopause) whose urine human chorionic gonadotropin (hCG) level is positive at Visit 1 before study medication.]
9. Patients with history of hypersensitivity to the ingredient of this drug or other sulfonamide derivatives
10. Patients treated with a drug known to affect glucose level such as systemic corticosteroids
11. Patients who received a investigational product within 16 weeks before enrollment
12. Patients who were judged to be inappropriate for this study by the Investigator/Sub-Investigator for any other reason |
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E.5 End points |
E.5.1 | Primary end point(s) |
Pharmacokinetics parameters |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Visit 8 (or one of Visit 2-7) |
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E.5.2 | Secondary end point(s) |
1 - Change in HbA1C
2 - Change in FPG
3 - Change in FBG
4 - Safety evaluation
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 to 4 : (Visit 1 -8) - from baseline to endpoint
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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 | 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.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 10 |