NCT04739241已完成4 期
Is Premixed Insulin Therapy an Alternative to Basal Bolus Therapy in Type 2 Diabetes Mellitus People Older Than 65 Years Old: A Pilot Randomised Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Change in HbA1c levels
研究概览
简要总结
The purpose of this study is to compare efficacy and security of premixed insulin treatment vs basal bolus insulin treatment in older patients with poorly controlled type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients
- •Age ≥ 65 years old
- •Type 2 diabetes mellitus
- •HbA1c ≥9% (74 mmol/mol)
- •Previously treated with one or two doses of basal insulin and oral hypoglycaemic agents
排除标准
- •Severe insulin-resistance
- •High doses of corticosteroids
- •Chemotherapy treatment
- •High comorbidity
- •Bad compliance of the treatment
- •Frequent severe hypoglycaemia
研究组 & 干预措施
Group A (experimental arm)
Experimental
Premixed insulin therapy
干预措施: premixed insulin therapy (Drug)
Group B (active comparator)
Active Comparator
Basal bolus insulin therapy
干预措施: basal bolus insulin therapy (Drug)
结局指标
主要结局
Change in HbA1c levels
时间窗: 12 months after recruitment
Change from baseline in HbA1c levels after 12 months of therapy
次要结局
- Change in the scores of the Diabetes Quality Of Life Questionnaire (EsDQOL) from recruitment to month 12.(12-month follow-up)
- Incidence of hypoglycaemia as an adverse effect of the treatment(every month during the 12-month follow-up)
- Change in the scores of the Diabetes Treatment Satisfaction Questionnaire (DTSQ) from recruitment to month 12.(12-month follow-up)
- Incidence of dosing errors as a measure of the safety of the treatment(every month during the 12-month follow-up)
研究者
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