NL-OMON52217招募中4 期
A Prospective, Randomized, Double-Blind, Sham-Controlled, Multi-Center Pivotal Study to Evaluate the Efficacy and Safety of Duodenal Mucosal Resurfacing (DMR) Using the Revita® System in Subjects with Type 2 Diabetes on Insulin therapy - REVITALIZE-1
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male; and non-pregnant, non-lactating females
- •2. Age between 21 and 70 years (both inclusive)
- •3. Subjects with type 2 diabetes on stable doses of (up to maximally approved
- •doses) of metformin and up to 2 ADAs (including either GLP1 or DPP-4i, and/or
- •thiazolidinediones [TZD]), requiring a minimum of 20 units up to a maximum of
- •60 units of basal insulin
- •4. Glycosylated Hemoglobin A1c (HbA1c) of 7.5-9.5% (both inclusive) confirmed
- •at the end of run-in period
- •5. Fasting Plasma Glucose (FPG) >=180 to <270 mg/dL (measured after overnight
- •8-hour fasting and 24-36 hours after the last dose of glargine at the end of at
- •least 3-week stable run-in period
- •6. Body Mass Index (BMI) >= 24 to <= 40 kg/m2
- •7. Women of Child-bearing potential (WOCBP) should have negative urine beta hCG
- •pregnancy test and must agree to use two established contraceptive methods
- •throughout the study duration
- •8. Able to sign an informed consent form and comply with study requirements.
排除标准
- •1. Known case of absolute insulin deficiency as indicated by clinical
- •assessment, and a fasting plasma C-peptide of <0.6 ng/ml
- •2. Any drugs or concomitant medications (such as psychoactive drugs such as
- •carbamazepine, phenobarbital, sympathomimetics (ephedrine etc.),
- •corticosteroids, anabolic steroids, and male sex hormones such as testosterone,
- •etc.) that can interfere with glucose metabolism
- •3. Subjects who either are on SGLT2i, meglitinides, sulphonylurea (SUs), short
- •or rapid acting insulin or any other class of ADA other than permitted baseline
- •ADAs at the time of consent or who have a known or documented SGLT2i and/or
- •metformin intolerance prior to the study
- •4. Recurrent or severe urinary tract or genital mycotic infections or history
- •of GU infection within 4 weeks prior to informed consent
- •5. ALT >3 times upper limit normal values unless if associated with underlying
- •6. Use of an investigational drug within 1 month or 5 half-lives (whichever is
- •longer) before the screening
- •7. Diagnosed with type 1 diabetes or with a recent history of ketoacidosis
- •8. Ketosis-prone T2D
- •9. History of non-healing diabetic ulcers or amputations
- •10. History of more than 1 severe hypoglycemia episode or unawareness within
- •past 6 months of screening
- •11. In case of two or more glucose alert values of <=70 mg/dL (3.9 mmol/L)
- •unless a clear correctable precipitating factor can be identified/clinically
- •significant hypoglycemia with self-
- •monitored or laboratory plasma glucose level < 54 mg/dL (3.0 mmol/L /
- •severe hypoglycemic episode requiring third party assistance occurring during
- •run-in period
- •12. Known intestinal autoimmune disease, as evidenced by either a positive
- •anti-glutamic acid decarboxylase (GAD) test, including Celiac disease, or
- •pre-existing symptoms of lupus
- •erythematosus, scleroderma, or other autoimmune connective tissue
- •disorder, which affects the small intestine
- •13. Secondary hypothyroidism or inadequately controlled primary hypothyroidism
- •(thyroid stimulating hormone (TSH) value outside the normal range at screening)
- •14. Known history of thyroid cancer or hyperthyroidism who have undergone
- •treatment within past 12 months or inadequately controlled hyperthyroidism
- •15. An uncontrolled endocrine condition such as multiple endocrine neoplasia
- •etc. (except T2D)
- •16. Known history of a structural or functional disorder of the esophagus,
- •including any swallowing disorder, esophageal chest pain disorders, or
- •drug-refractory esophageal reflux
- •symptoms, active and uncontrolled Gastroesophageal Reflux Disease
- •(GERD) (grade 3 esophagitis or greater)
- •17. Known history of a structural or functional disorder of the stomach,
- •including gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (a
- •large hiatal hernia or type II and higher
- •paraoesophageal hernia) cancer or any other disorder of the stomach
- •18. Previous GI surgery that could affect the ability to treat the duodenum
- •such as subjects who have had a Billroth 2, Roux-en-Y gastric bypass, gastric
- •sleeve or other similar procedures
- •or conditions
- 另有 4 项未显示
研究者
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