Sonias Combination Tablets LD Special Drug Use Surveillance Survey in Patients With Type 2 Diabetes Mellitus Who Respond Poorly to Pioglitazone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 294
- 主要终点
- Frequency of Adverse Drug Reactions
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of long-term use of pioglitazone/glimepiride combination tablets (Sonias Combination Tablets LD) in patients with type 2 diabetes mellitus who respond poorly to pioglitazone hydrochloride monotherapy (pioglitazone at 15 mg/day) in the routine clinical setting.
详细描述
This is a special drug use surveillance on long-term use of pioglitazone/glimepiride combination tablets (Sonias Combination Tablets LD) designed to investigate the frequency of adverse drug reactions in patients with type 2 diabetes mellitus who respond poorly to pioglitazone hydrochloride monotherapy (pioglitazone at 15 mg/day).
The usual adult dosage is one tablet (15 mg/1 mg of pioglitazone/glimepiride) administered orally once daily before or after breakfast.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes mellitus for whom treatment with pioglitazone hydrochloride monotherapy (pioglitazone at 15 mg/day) is considered inefficacious as per physician's assessment and for whom long-term treatment with pioglitazone/glimepiride combination tablets is considered necessary
排除标准
- •(1) Patients with cardiac failure or a history of cardiac failure (2) Patients with serious hepatic or renal impairment (3) Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (4) Patients with severe infection, severe trauma, or pre- and post-operative patients (5) Patients with gastrointestinal disorders such as diarrhea and vomiting (6) Pregnant or potentially pregnant women (7) Patients with a history of hypersensitivity to the ingredients in Sonias Combination Tablets or sulfonamides
研究组 & 干预措施
Pioglitazone/glimepiride
Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
干预措施: Pioglitazone/glimepiride (Drug)
结局指标
主要结局
Frequency of Adverse Drug Reactions
时间窗: 12 months
Frequency of adverse drug reactions is defined as the number of participants with adverse drug reactions. Frequency, seriousness, and time to onset of adverse drug reactions were tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Frequency of Serious Adverse Drug Reactions
时间窗: 12 months
Frequency of serious adverse drug reactions is defined at the number of participants with serious adverse drug reactions. Frequency of serious adverse drug reactions were tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
次要结局
- Change From Baseline in Fasting Blood Glucose Level(Baseline, Months 3, 6, 9, 12 and at Final assessment)
- Change From Baseline in Fasting Insulin Level(Baseline, Months 3, 6, 9, 12 and at Final assessment)
- Change From Baseline in Glycosylated Hemoglobin (HbA1c)(Baseline, Months 3, 6, 9, 12 and at Final assessment)