A 16-week, Randomized, Open-label, Controlled Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine Versus Lantus in Patients With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 59
- 试验地点
- 3
- 主要终点
- Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL])
研究概览
简要总结
Primary Objective:
- To compare the glucose control during treatment with a new formulation of insulin glargine and Lantus in adult participants with type 1 diabetes mellitus
Secondary Objectives:
- To compare a new formulation of insulin glargine and Lantus given in the morning or in the evening
- To compare the incidence and frequency of hypoglycemic episodes
- To assess the safety and tolerability of the new formulation of insulin glargine
详细描述
- Up to 4-week screening period;
- 16-week open-label comparative efficacy and safety treatment period;
- 4-week post-treatment safety follow-up period.
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
- 18 Years 至 70 Years（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
HOE901-U300 Morning Then Evening
HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 millimole per liter (mmol/L).
干预措施: HOE901-U300 (new formulation of insulin glargine) (Drug)
HOE901-U300 Evening Then Morning
HOE901-U300 (new insulin glargine 300 U/mL) SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L.
干预措施: HOE901-U300 (new formulation of insulin glargine) (Drug)
Lantus Morning Then Evening
Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L.
干预措施: Lantus (insulin glargine) (Drug)
Lantus Evening Then Morning
Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L.
干预措施: Lantus (insulin glargine) (Drug)
结局指标
主要结局
Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL])
时间窗: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)
Percentage of time with glucose within glycemic range (4.4-7.8 mmol/L) was assessed by the total time within glycemic range divided by the length of the assessment interval.
次要结局
- Percentage of Time Above the Upper Limit of Glycemic Range (Greater Than [>] 7.8 mmol/L [(140 mg/dL])(Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B))
- Percentage of Time Below The Lower Limit of Glycemic Range (<4.4 mmol/L [80 mg/dL])(Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B))
- Evaluation of Diurnal Glucose Exposure, Variability, and Stability(Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B))
- Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL]) in the Last Four Hours of Each Dosing Interval at Weeks 7 and 8 in Period A and Weeks 15 and 16 in Period B(Weeks 7-8 in Period A and Weeks 15-16 in Period B)
- Change in HbA1c From Baseline to Week 8 and 16(Baseline, Week 8, 16)
- Change in Fasting Plasma Glucose (FPG) From Baseline to Week 8 and 16(Baseline, Week 8, 16)
- Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 8 and 16(Baseline, Week 8, 16)
- Change in Basal Insulin Daily Dose From Baseline to Week 8 and 16(Baseline, Week 8, 16)
- Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline Up to Week 16(Up to Week 16)