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临床试验/NCT07374328
NCT07374328招募中1 期

Comparison Of Two Triple Hypoglycemic Regimens In Achieving Glycemic Control And Diabetes Remission In Hospitalized Patients With Newly Diagnosed Type 2 Diabetes Mellitus: A Multicenter, Randomized, Clinical Study

Second Affiliated Hospital of Guangzhou Medical University1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2025年6月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
240
试验地点
1
主要终点
Diabetes remission rate

研究概览

简要总结

This study is a multicenter, randomized, controlled study. A sample size of 240 cases is proposed to be included. The inclusion criteria are: (1) patients with newly diagnosed type 2 diabetes; (2) age between 18 and 65 years old; (3) HbA1c ≥ 9.0%. The exclusion criteria include: (1) type 1 diabetes; (2) elevated creatinine or urinary albumin/creatinine; (3) combined with coronary heart disease, tumor or pregnancy; (4) receiving glucocorticoids. The selected participants are randomly divided into two groups: one group is the semaglutide group, and the other isthe oral medication group. The treatment plan is as follows. Semaglutide group: 0.25 mg per week in the first month, 0.5 mg per week in the second month, and 1.0mg per week from the 3rd to the 8th month of semaglutide. Oral medication group: Sitagliptin 0.1g per day. Both groups were simultaneously treated with metformin (1.0g daily, divided into two doses) and empagliflozin (10mg daily). The first phase of the study was as follows: Semaglutide group: Treatment was initiated until 6 months after the titration dose of 1mg was reached; Oral medication group: Initiate treatment until 6 months after reaching a fixed dose. At the end of the first stage of the study, for the selected participants with HbA1c<6.5%, the hypoglycemic drugs were discontinued and they entered the second stage of the study. The study was concluded after a 3-month follow-up. The evaluation indicators include: effectiveness indicators (HbA1c, diabetes remission rate, continuous glucose monitoring), safety indicators (hypoglycemia, adverse reactions, etc.).

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
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with newly diagnosed type 2 diabetes.
  • Age between 18 and 65 years old.
  • HbA1c ≥ 9.0%.

排除标准

  • Type 1 diabetes.
  • Elevated creatinine or urinary albumin/creatinine.
  • Combined with coronary heart disease, tumor or pregnancy.
  • Receiving glucocorticoids.

研究组 & 干预措施

Semaglutide group: patients receive semaglutide treatment.

Experimental

Patients receive 0.25 mg per week in the first month, 0.5 mg per week in the second month, and 1.0mg of semaglutide per week from the 3rd to the 8th month.

干预措施: Semaglutide (1 Mg Dose) (Drug)

Oral medication group: patients receive triple hypoglycemic oral medications.

Active Comparator

Patients in oral medication group received sitagliptin 0.1g per day. Both groups were simultaneously treated with metformin (1.0g daily, divided into two doses) and empagliflozin (10mg daily).

干预措施: Sitagliptin (DPP4 inhibitor) (Drug)

结局指标

主要结局

Diabetes remission rate

时间窗: From enrollment to the end of follow-up at 11 months

次要结局

  • HbA1c(From enrollment to the end of follow-up at 11 months)
  • Hypoglycemia rate(From enrollment to the end of follow-up at 11 months)
  • Adverse reactions(From enrollment to the end of follow-up at 11 months)

研究者

发起方
Second Affiliated Hospital of Guangzhou Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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