Pioglitazone/Glimepiride (Sonias) Combination Tablets Special Drug Use Surveillance Survey on Long-term Use for in Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,168
- 主要终点
- Number of Participants With 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 Sonias Combination Tablets in patients with type 2 diabetes mellitus in the routine clinical setting.
详细描述
This a special drug use surveillance on long-term use of pioglitazone/glimepiride combination tablets (Sonias Combination Tablets) designed to investigate the frequency of adverse drug reactions in patients with type 2 diabetes mellitus in the routine clinical setting.
The usual adult dosage is one tablet of Sonias administered orally once daily before or after breakfast (15 mg/1 mg or 30 mg/3 mg of pioglitazone/glimepiride).
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 a physician has concluded that combination therapy with pioglitazone hydrochloride and glimepiride is appropriate and for whom long-term treatment with Sonias 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 or 30 mg/3 mg, orally once daily before or after breakfast
干预措施: Pioglitazone/glimepiride (Drug)
结局指标
主要结局
Number of Participants With Adverse Drug Reactions
时间窗: For 12 months
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.
次要结局
- Change From Baseline in Glycosylated Hemoglobin (HbA1c)(Baseline, and Months 3, 6, 9, 12 and at Final Assessment)
- Glycosylated Hemoglobin (HbA1c)(Baseline, and 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 Fasting Blood Glucose Level(Baseline, Months 3, 6, 9, 12 and at Final Assessment)
- Fasting Blood Glucose Level(Baseline, Months 3, 6, 9, 12 and at Final Assessment)
- Fasting Insulin Level(Baseline, Months 3, 6, 9, 12 and at Final Assessment)