跳至主要内容
临床试验/NCT03458715
NCT03458715Unknown4 期

The Efficacy and Safety of Sodium-glucose Co-transporter 2 Inhibitor or Dipeptidyl Peptidase 4 Inhibitor Added to Premix Insulin Injection Twice Daily in Uncontrolled Type 2 Diabetes Patients

Mackay Memorial Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年9月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
120
试验地点
1
主要终点
Glycated hemoglobin (HbA1c)

研究概览

简要总结

The population of type 2 diabetes increased enormously worldwide. As disease progression, uncontrolled type 2 diabetes patients need multiple daily insulin injections, but the risk of body weight gain and hypoglycemia will increase. In recent years, the newly oral anti-hypoglycemic agents developed, such as dipeptidyl peptidase-4 inhibitors (DPP4i) and sodium-glucose co-transporter 2 inhibitors (SGLT2i). The former indirectly stimulate insulin secretion and suppress glucagon through increase incretin. The later inhibit re-absorption of blood glucose in proximal renal tubule to improve hyperglycemia. According to the guideline published in 2017 by American diabetes Associations, if patients received premix insulin injections twice daily and their glycemic control can't meet the target, increase the frequency of injection such as basal bolus would be considered. However, it is difficult for some patients and it may cause more hypoglycemia and gain of body weight. Because previous report revealed dipeptidyl peptidase-4 inhibitors or sodium-glucose co-transporter 2 inhibitors added to insulin resulted in better glycemic control, but there was no direct comparison, so we design this study to observe the efficacy of these two drugs in uncontrolled diabetes patient received twice daily insulin injections.

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
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetes patient received premix insulin twice daily and HbA1c>7%
  • >20 years old

排除标准

  • Type 1 diabetes and gestational diabetes
  • Diabetic ketoacidosis in previous 6 months
  • Urinary tract infection in previous 6 months
  • Pancreatitis in previous 6 months
  • estimated GFR<45 mL/min/1.73m2
  • Patient whom already received DPP4 inhibitor or SGLT2 inhibitor

研究组 & 干预措施

SGLT2 inhibitor (Empagliflozin 25 MG)

Experimental

We add SGLT2 inhibitor (Empagliflozin 25 MG, oral, once daily) to type 2 diabetes patient poorly controlled with premix insulin therapy for 6 months.

干预措施: SGLT2 inhibitor (Empagliflozin 25 MG) (Drug)

DPP4 inhibitor (Linagliptin 5 MG)

Active Comparator

We add DPP4 inhibitor (Linagliptin 5 MG, oral, once daily) to type 2 diabetes patient poorly controlled with premix insulin therapy.for 6 months.

干预措施: DPP4 inhibitor (Linagliptin 5 MG) (Drug)

结局指标

主要结局

Glycated hemoglobin (HbA1c)

时间窗: measurement at baseline, 12 week and 24 week

change in glycated hemoglobin (HbA1c) in percentage from baseline to week 24

次要结局

  • Body weight(measurement at baseline, 12 week and 24 week)
  • Fasting blood glucose(measurement at baseline, 12 week and 24 week)
  • Postprandial blood glucose(measurement at baseline, 12 week and 24 week)
  • Hypoglycemia event(recorded at 12 week and 24 week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验