Safety and Feasibility of Endoscopic Application of a Novel Therapy for Duodenal Mucosal Regeneration in the Treatment of Type II Diabetes

Endogenex, Inc.2 个研究点分布在 1 个国家目标入组 65 人2021年4月20日

适应症Type 2 Diabetes

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Type 2 Diabetes
发起方: Endogenex, Inc.
入组人数: 65
试验地点: 2
主要终点: Device- or Procedure-related SAE Rate
状态: 已完成
最后更新: 3个月前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

This is an open-label study to assess the safety and feasibility of the DyaMX device for endoscopic duodenal mucosal regeneration in individuals with type 2 diabetes inadequately controlled on glucose-lowering medications.

详细描述

Individuals who sign the informed consent will be screened for study eligibility. Eligible participants will be treated with the DyaMX procedure and followed up for 48 weeks.

注册库

clinicaltrials.gov

开始日期

2021年4月20日

结束日期

2024年12月22日

最后更新

3个月前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Endogenex, Inc.

责任方

Sponsor

入排标准

入选标准

•18-70 years of age
•Current diagnosis of T2D
•History of T2D for less than or equal to 10 years, or use insulin for less or equal to 10 years
•HbA1C of 7.5-11.0%
•BMI 24-40 kg/m2
•If treated with non-insulin glucose lowering mediations, the medications (1-4 medications) should be stable for at least 12 weeks prior to baseline visit. If treated with basal insulin, the daily insulin dose should be within 20-60 IU.
•Agree not to donate blood during participation in the study.
•If treated with non-insulin glucose lowering medications, participant should have weight stability (defined as a \< 5% change in body weight) for at least 12 weeks prior to the screening visit
•Able to comply with study requirements and understand and sign the Informed Consent Form
•Women of childbearing potential must be using an acceptable method of contraception throughout the study

排除标准

•Diagnosed with type 1 diabetes
•History of diabetic ketoacidosis or hyperosmolar nonketotic coma
•Probable insulin production failure, defined as overnight fasting C-peptide serum \<1 ng/mL (333pmol/l).
•Previous use of any types of insulin for \>1 month (at any time, except for treatment of gestational diabetes) in last 2 years for those on non-insulin medications.
•Current use of multiple daily dose insulin or insulin pump
•Hypoglycemia unawareness
•History of ≥1 severe hypoglycemia (defined by needing for third-party assistance), unless a clear correctable precipitating factor can be identified, in past 6 months from the screening visit
•Known autoimmune disease, as evidenced by a positive anti-glutamic acid decarboxylase (GAD) test, including but not limited to celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder.
•Previous GI surgery that has changed GI anatomy or could limit treatment of the duodenum, such as Billroth 2, Roux-en-Y gastric bypass, gastric band or other similar procedures or conditions.
•Known history of a structural or functional disorder of the upper GI tract that may impede passage of the device through the upper GI tract or increase risk of tissue damage during an endoscopic procedure, including esophagitis, stricture/stenosis, varices, diverticula, or other disorder of the esophagus, stomach and duodenum.