Population pharmacokinetics study with Amaryl® (Glimepiride) in pediatric and adult population with type 2 diabetes
- Conditions
- Patients with type 2 diabetesMedDRA version: 17.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2014-004643-12-Outside-EU/EEA
- Lead Sponsor
- Sanofi-aventis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 130
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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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;Secondary Objective: 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;Primary end point(s): Pharmacokinetics parameters ;Timepoint(s) of evaluation of this end point: Visit 8 (or one of Visit 2-7)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1 - Change in HbA1C <br>2 - Change in FPG <br>3 - Change in FBG <br>4 - Safety evaluation<br>;Timepoint(s) of evaluation of this end point: 1 to 4 : (Visit 1 -8) - from baseline to endpoint <br>