EUCTR2014-004643-12-Outside-EU/EEA进行中（未招募）不适用
Post-marketing study of Amaryl® (Glimepiride) in patients with type 2 diabetes to investigate pediatric and adult population pharmacokinetics [multicenter, non-comparative, 12-28 weeks, non-blind titration (0.5-6 mg/day)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
相似试验
未知
不适用
CLINICAL EFFICACY AND SAFETY OF AMARYL M ® (FIXED COMBINATION GLIMEPIRIDE AND METFORMIN) IN THE TREATMENT OF TYPE 2 DIABETIC PATIENTS, NOT CONTROLLED OR GLIMEPIRIDE MONOTHERAPY OF METFORMIN.PER-004-11Sanofi-Aventis del Peru S.A.,
已完成
4 期
PALT02JPRN-jRCT2031200177Ishibashi Shun20
招募中
3 期
effect of amiloride-h in central serous chorioretinopathyIRCT20190311043009N1Esfahan University of Medical Sciences50
招募中
1 期
Evaluating the effects of treatmen with amitriptyline as a tricyclic antidepressant drug on serum prolactin levels in patients with chronic migraine and its relation with patient’s quality of life and functioIRCT20211013052758N1Semnan University of Medical Sciences20
尚未招募
2 期
A study to determine the efficacy of amritadya guggulu and haritaki churna in medo rogaCTRI/2023/11/059698Prof Anjana Mishra