Patients with type 2 diabetes MedDRA version: 17.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Amaryl® (Glimepiride)
Product Name: Amaryl® (Glimepiride)
Product Code: HOE490
Pharmaceutical Form: Tablet
INN or Proposed INN: GLIMEPIRIDE
CAS Number: 93479-97-1
Current Sponsor code: HO
Sponsors
Sanofi-aventis
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 - Change in HbA1C 2 - Change in FPG 3 - Change in FBG 4 - Safety evaluation ;Timepoint(s) of evaluation of this end point: 1 to 4 : (Visit 1 -8) - from baseline to endpoint | — |
Countries
Japan
Contacts
Public ContactTrial Transparency Team
Sanofi-aventis
Outcome results
None listed