跳至主要内容
临床试验/NCT02941445
NCT02941445已完成4 期

Weight Maintenance With Dipeptidyl Peptidase 4 (DPP4) Inhibitor Sitagliptin in Combination With Metformin After Liragludite Induced Weight Loss

University Medical Centre Ljubljana0 个研究点目标入组 24 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
24
主要终点
Change in body weight.

研究概览

简要总结

Weight reduction is the most important treatment target in obese women with polycystic ovary syndrome (PCOS), yet it is usually hardly achievable with lifestyle intervention alone. Glucagon-like peptide 1 (GLP-1) receptor agonist (RA) liraglutide was recently approved as an anti-obesity drug but with some limitations, which include high cost and the lack of long-term efficacy and safety data regarding weight reduction. In addition, weight loss achieved with liraglutide is often non-sustainable after treatment cessation. Although DPP-4 inhibitors are weight neutral, they reduced weight regain in animals previously treated with GLP-1 RAs if they were switched to DPP-4 inhibitor rather than placebo. The aim is to evaluate whether DPP-4 inhibitor sitagliptin in combination with metformin reduce body weight regain more effectively than metformin alone in obese PCOS who had been previously treated with liraglutide.

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 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18 years old to menopause
  • polycystic ovary syndrome (NICHD criteria)
  • BMI of 30kg/m2 or higher

排除标准

  • type 1 or type 2 diabetes mellitus
  • history of carcinoma
  • Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
  • personal or family history of multiple endocrine neoplasia type 2
  • significant cardiovascular, kidney or hepatic disease
  • the use of statins, within 90 days prior to study entry

研究组 & 干预措施

COMBO (sitagliptin and metformin)

Experimental

metformin 1000 mg BID and sitagliptin 50mg BID for 12 weeks

干预措施: sitagliptin and metformin (Drug)

MET (metformin)

Experimental

metformin 1000 mg BID

干预措施: Metformin (Drug)

结局指标

主要结局

Change in body weight.

时间窗: Patient's body weight was measured at the baseline and after 12 weeks of clinical trial.

次要结局

  • Change in body mass indey (BMI).(Patient's body height was measured at the baseline. Body weight was measured at the baseline and after 12 weeks of clinical trial.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrej Janez

MD PhD

University Medical Centre Ljubljana

相似试验

Weight Maintenance With Dipeptidyl Peptidase 4... | 临床试验