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临床试验/NCT03297879
NCT03297879已完成4 期

Beijing Chao-Yang Hospital, Capital Medical University

Beijing Chao Yang Hospital0 个研究点目标入组 230 人开始时间: 2013年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
230
主要终点
The change of HbA1c

研究概览

简要总结

The present study assessed the therapeutic effect of exenatide and metformin as the initial therapy in overweight/obese patients with newly diagnosed Type 2 diabetes (T2D).

详细描述

The present study was a prospective, nonrandomized, interventional study.The drug-naïve, overweight or obese patients with newly diagnosed T2D were consecutively enrolled. The inclusion criteria: 1) age 20 - <65 years, 2) body mass index (BMI) ≥ 24 kg/m2 [7], and 3) HbA1c ≥ 7% (53mmol/mol). An oral glucose tolerance test was performed during the screenings. All of the patients have no diabetes antibodies and were diagnosed with T2D within the previous 3 months, according to the ADA diagnostic criteria. None of the patients had administered anti-diabetic drugs or diet therapy before participation. Neither of the patients presented any history of pancreatitis, coronary artery disease, liver function impairment, renal function impairment, intestinal surgery, chronic hypoxic diseases (emphysema and cor pulmonale), infectious disease, hematological disease, systemic inflammatory disease, or cancer. Patients who were pregnant, possibly pregnant, or ingesting agents known to influence glucose or lipid metabolism were also excluded.

研究设计

研究类型
Interventional
分配方式
Non 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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 20 - <65 years,
  • body mass index (BMI) ≥ 24 kg/m2,
  • HbA1c ≥ 7% (53mmol/mol).
  • diabetes antibodies (-)
  • diagnosed with T2D within the previous 3 months

排除标准

  • anti-diabetic drugs or diet therapy before participation
  • pancreatitis
  • coronary artery disease
  • liver function impairment
  • renal function impairment
  • intestinal surgery
  • chronic hypoxic diseases (emphysema and cor pulmonale)
  • infectious disease
  • hematological disease
  • systemic inflammatory disease
  • pregnant, possibly pregnant
  • ingesting agents known to influence glucose or lipid metabolism

研究组 & 干预措施

exenatide group

Experimental

The drug-naïve, overweight or obese patients with newly diagnosed T2D

干预措施: Exenatide or metformin hydrochloride (Drug)

metformin group

Active Comparator

The drug-naïve, overweight or obese patients with newly diagnosed T2D

干预措施: Exenatide or metformin hydrochloride (Drug)

结局指标

主要结局

The change of HbA1c

时间窗: baseline and 12 weeks

次要结局

未报告次要终点

研究者

发起方
Beijing Chao Yang Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guang Wang

Director of Endocrinology,Principal Investigator

Beijing Chao Yang Hospital

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