Actos Tablets Special Drug Use Surveillance "Combined Use of Biguanides / Long-term Treatment"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 899
- 主要终点
- Number of Participants Reporting One or More Adverse Drug Reactions
研究概览
简要总结
To investigate the safety and efficacy of long-term treatment with pioglitazone (Actos tablets) in combination with biguanides (for 12 months after the start of pioglitazone tablets treatment) in patients with type 2 diabetes mellitus.
详细描述
This is a special drug use surveillance with an observation period of 12 months designed to investigate the safety and efficacy of pioglitazone (Actos) in the routine clinical setting in patients with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy (planned sample size, 1000).
The usual adult dosage is 15 to 30 mg of pioglitazone administered orally once daily before or after breakfast. Dose adjustment will be made according to gender, age, and symptoms with an upper limit of 45 mg.
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 who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy
- •Patients with available HbA1c data within the 1 month prior to the start of Actos Tablets treatment
- •Patients likely to be available for a 12-month observation after the start of Actos Tablets treatment
排除标准
- •Patients who have received Actos Tablets within the past 3 months.
- •Patients who started treatment with biguanides and Actos Tablets simultaneously
- •Patients who discontinued biguanides and switched to Actos Tablets treatment.
- •Patients who received additional biguanides after the start of Actos Tablets treatment
- •Patients with contraindications to Actos Tablets treatment
研究组 & 干预措施
Pioglitazone 15 mg to 30 mg
administered orally once daily
干预措施: Pioglitazone (Drug)
结局指标
主要结局
Number of Participants Reporting One or More Adverse Drug Reactions
时间窗: Baseline up to 12 months
Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs 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.
Number of Participants Reporting One or More Serious Adverse Drug Reactions
时间窗: Baseline up to 12 months
Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
次要结局
- Change From Baseline in Glycosylated Hemoglobin (HbA1c)(Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12))
- Change From Baseline in Fasting Blood Glucose(Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12))
- Change From Baseline in Immunoreactive Insulin (IRI)(Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12))
- Change From Baseline in Body Weight(Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12))
- Change From Baseline Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)(Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12))