Randomized, Open-label, SU-controlled Study of 24-week Duration to Compare Metformin/Vildagliptin + Basal Insulin Versus Metformin/SU + Basal Insulin in T2DM Patients Starting Basal Insulin After Failing Metformin/SU
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Percentage of Patients Who Reported at Least One Symptomatic Hypoglycemic Event During the 24 Week Randomized Period in Both Treatment Arms
研究概览
简要总结
To compare a therapeutic strategy combining vildagliptin+metformin + Basal Insulin versus SU+metformin + Basal Insulin on the incidence of hypoglycemic events over 24 weeks.
详细描述
This study, conducted in T2DM patients failing a dual therapy with metformin/SU in whom the decision to start basal insulin has been taken, will compare vildagliptin+metformin versus the previously used SU+met combination (regimen kept unchanged) in association with basal insulin, up-titrated as per usual algorithms primarily based on FPG to obtain a similar improvement in glycemic control in both arms, on the incidence of hypoglycemic episodes over 24 weeks.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T2DM patients inadequately controlled with metformin+ SU combination therapy at max tolerated doses and in whom the decision to start basal insulin has been taken
- •with stable metformin+ SU combination therapy for at least 12 weeks prior to randomization
- •with a glycemic target of HbA1c <= 7%
- •with HbA1c at inclusion >7% and <=9%
- •Patients willing and able to start basal insulin and perform appropriate self monitoring of blood glucose (SMBG)
排除标准
- •contraindication for either SUs, metformin or insulin and history of hypersensitivity to vildagliptin
- •acute or chronic diseases that interfere with efficacy/safety results of this trial or put patient at risk
- •Other protocol defined inclusion/exclusion criteria may apply
研究组 & 干预措施
SU+metformin + Basal Insulin
Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
干预措施: Metformin (Drug)
SU+metformin + Basal Insulin
Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
干预措施: sulfonylurea (SU) (Drug)
SU+metformin + Basal Insulin
Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
干预措施: Basal Insulin (Drug)
Metformin/vildagliptin + Basal Insulin
Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
干预措施: Vildagliptin (Drug)
Metformin/vildagliptin + Basal Insulin
Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
干预措施: Metformin (Drug)
Metformin/vildagliptin + Basal Insulin
Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
干预措施: Basal Insulin (Drug)
结局指标
主要结局
Percentage of Patients Who Reported at Least One Symptomatic Hypoglycemic Event During the 24 Week Randomized Period in Both Treatment Arms
时间窗: 24 weeks
次要结局
- Change From Baseline in Body Weight in Both Treatment Arms(Baseline, Week 24)
- Change From Baseline in HbA1c to Week 24 in Both Treatment Arms(Baseline, Week 24)
- Mean Daily Insulin Dose at Week 24(Week 24)
- Percent of Participants That Reach Therapeutic Goal (HbA1c ≤ 7%) at Week 24 Without Any Hypoglycaemic Episode (Symptomatic or Not) and Without Any Weight Gain (Variation ≥3% Compared to Baseline)(week 24)
- Percentage of Patients With Severe and Confirmed Hypoglycemic Events(24 weeks)
- Percentage of Patients Reaching Their Glycemic Target Without Hypoglycemic Events(24 weeks)