NCT05607160已完成不适用
ELDERLY-T: A Non-interventional, Multicentre, Prospective Observational Study on the Effectiveness and Safety of Insulin Glargine 300 U/ml in Elderly Patients ≥75 Years of Age With Type 2 Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Proportion of participants achieving the HbA1c target value
研究概览
简要总结
Primary objective:
- Glycemic control after initiation or switch to insulin glargine 300 U/ml in everyday clinical practice
Secondary objective:
- Treatment satisfaction
详细描述
Study duration per participant is expected to be approximately 24 weeks
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus (T2DM) with oral antidiabetic drug (OAD) ± Glucagon-like-peptide-1 receptor agonist (GLP-1-RA) ± basal insulin (other than insulin glargine 300 U/ml)
- •Age ≥75 years incl. patients from outpatient and inpatient care forms
- •Glycohaemoglobin (Hba1c) ≥8.0% and ≤11.0%
- •Inadequate glycaemic control (HbA1c), defined by the treating physician
- •Ability and willingness to perform fasting blood glucose (BG) measurements themselves or with the support of third parties
- •Signed consent form
排除标准
- •Type 1 diabetes mellitus
- •Age <75 years
- •Contraindications to insulin glargine 300 U/ml
- •Short-acting insulin in medication
- •Current participation in clinical research
- •Life expectancy <1 year
- •Known alcohol or drug abuse
- •Mini Mental State Examination Score ≤19
- •The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
结局指标
主要结局
Proportion of participants achieving the HbA1c target value
时间窗: 6 months
Proportion of participants achieving their individual HbA1c target value (pre-defined by the treating physician) within 6 months of initiation or switch to insulin glargine 300 U/ml
次要结局
- Relative proportion of participants achieving their individual HbA1c target value (pre-defined by the treating physician) within 3 months of initiation or switch to insulin glargine 300 U/ml(3 months)
- Absolute proportion of participants who achieve their individual fasting blood glucose (FBG) target value (pre-defined by the treating physician) within 3 months of initiation or switch to insulin glargine 300 U/ml(3 months)
- Relative proportion of participants who achieve their individual fasting blood glucose (FBG) target value (pre-defined by the treating physician) within 3 months of initiation or switch to insulin glargine 300 U/ml(3 months)
- Absolute proportion of participants who achieve their individual FBG target value (pre-defined by the treating physician) within 6 months of initiation or switch to insulin glargine 300 U/ml(6 months)
- Relative proportion of participants who achieve their individual FBG target value (pre-defined by the treating physician) within 6 months of initiation or switch to insulin glargine 300 U/ml(6 months)
- Absolute change in treatment satisfaction total score, from baseline to month 6(Baseline to month 6)
- Absolute proportion of participants achieving their individual HbA1c target value (pre-defined by the treating physician) within 3 months of initiation or switch to insulin glargine 300 U/ml(3 months)
- Absolute proportion of participants who achieve their individual FBG and HbA1c target values, from baseline to month 3 and 6(Baseline to month 3 and 6)
- Absolute change in Geriatric Depression Scale (GDS) total score, from baseline to month 6(Baseline to month 6)
- Relative proportion of patients who achieve their individual FBG or HbA1c target value, from baseline to month 3 and 6(Baseline to month 3 and 6)
- Absolute change in FBG (mg/dl, mmol/l), from baseline to month 3 and 6(Baseline to month 3 and 6)
- Absolute change in HbA1c (%), from baseline to month 3 and 6(Baseline to month 3 and 6)
- Absolute proportion of patients who achieve their individual FBG or HbA1c target value, from baseline to month 3 and 6(Baseline to month 3 and 6)
- Absolute change in Diabetes-related quality of life total score, from baseline to month 6(Baseline to month 6)
- Relative proportion of participants who achieve their individual FBG and HbA1c target values, from baseline to month 3 and 6(Baseline to month 3 and 6)
研究者
研究点 (1)
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