A 28-week, Prospective, Single-arm, Phase 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 U/mL in Combination With Prandial Rapid-acting Insulin Analogue in Patients With Type 1 Diabetes Previously Uncontrolled on Twice-daily Basal Insulin as Part of Basal-bolus Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 170
- 试验地点
- 11
- 主要终点
- Mean change in HbA1c
研究概览
简要总结
Primary Objective:
To evaluate the efficacy of switching treatment from twice-daily basal insulin to once-daily insulin glargine (U300) as part of basal bolus regime in terms of glycated hemoglobin improvement (reduction by at least 0.3%), in uncontrolled type 1 diabetes mellitus patients.
Secondary Objectives:
- To evaluate other efficacy parameters in terms of glycemic control as well as safety including hypoglycemia events, weight changes, and adverse events.
- To evaluate the effect of insulin glargine (U300) on diabetes treatment satisfaction and fear of hypoglycemia as well as patient's satisfaction regarding the number of daily injections.
详细描述
The estimated average study duration is 29 weeks, including run-in period of 4 weeks; treatment period of 24 weeks, and follow-up period of 1 week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Insulin glargine (U300)
Self-administered subcutaneously once daily in the morning, at the same time.The initial dose for patients switching from insulin glargine is 80% of the total daily dose of basal insulin agent that was discontinued. Thereafter, insulin glargine (U300) will follow a titration algorithm for dose adjustment.
干预措施: INSULIN GLARGINE (U300) (Drug)
结局指标
主要结局
Mean change in HbA1c
时间窗: From baseline to Week 24
Mean change in glycated hemoglobin (HbA1c) from baseline to Week 24 (%)
次要结局
- Mean change in daily insulin doses(From baseline to Week 24)
- Mean change in HbA1c(From baseline to Week 12)
- Mean change in fasting plasma glucose (FPG)(From baseline to Week 12 and Week 24)
- Adverse events (AEs)(Up to 28 weeks)
- Proportion of patients with no deterioration in HbA1c(From baseline to Week 24)
- Mean change in body weight(From baseline to Week 12 and Week 24)
- Proportion of patients experiencing hypoglycemia(Up to 28 weeks)
- Mean change in fasting SMBG(From baseline to Week 12 and Week 24)
- Mean change in 8-point SMBG(From baseline to Week 12 and Week 24)
- Proportion of patients achieving HbA1c target of <7.0%(At Weeks 12 and 24)
- Proportion of patients achieving HbA1c target of <7.0% without hypoglycemia event(At Weeks 12 and 24)
- Number of patients experiencing hypoglycemia(Up to 28 weeks)
- Number of hypoglycemic events per patient-year(Up to 28 weeks)
- Proportion of patients achieving HbA1c improvement of at least 0.3% without nocturnal hypoglycemia(From baseline to Week 24)
- Proportion of patients with any improvement in HbA1c(From baseline to Week 24)