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临床试验/EUCTR2019-002977-69-IT
EUCTR2019-002977-69-IT进行中(未招募)1 期

Durability of combination of insulin and GLP-1 receptor agonist or SGLT-2 inhibitors versus basal bolus insulin regimen in type 2 diabetes: a randomized controlled trial - BEYOND

A.O.U. Università degli Studi della Campania Luigi Vanvitelli0 个研究点目标入组 110 人开始时间: 2021年5月24日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
110

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Patients on insulin therapy basal bolus stable for at least one year associated or not with metformin
  • Insufficient glycemic control (HbA1c> 7.5%
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 110
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 110

排除标准

  • Type 1 diabetes or diabetes secondary to specific causes
  • Previous treatment (within the last 3 months) with a GLP-1RA or a DPPIV inhibitor
  • Contraindications to the use of GLP-1RA (pancreatitis, gallbladder stones)
  • Pregnancy or pregnancy scheduled during the study period
  • Serum creatinine> 1.3 mg / dL in women and> 1.4 mg / dL in men
  • GFR <30 ml / min
  • History of cancer or anti-neoplastic therapy in the 5 years prior to randomization
  • Current therapy with oral, topical or systemic glucocorticoids, or with atypical anti-psychotics.

研究者

发起方
A.O.U. Università degli Studi della Campania Luigi Vanvitelli

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