NL-OMON53542尚未招募不适用
A randomized double-blind sham-controlled trial to evaluate efficacy and safety of REvita® DMR Treatment ParadIgm 1 and RetreatmeNt in patients with type 2 Diabetes using non-insulin glucose lowering medications. - REMIND study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 18
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. Diagnosed with Type 2 Diabetes.
- •2. Age >= 18 to <= 75 years.
- •3. Insulin naïve patients who are on stable dose (maximally approved or
- •tolerated dose) of 2 or more glucose lowering drugs, including metformin, SU,
- •SLGT-2i, GLP-1RA or DPP-4i and/or, TZD for at least 12 weeks.
- •4. BMI >= 24 and <= 40 kg/m2
- •5. HbA1c of >= 58 mmol/mol (7.5%) and <= 86 mmol/mol (10.0%).
- •a. In case of prestudy SU use, an HbA1c of >= 53 mmol/mol (7.0%).
- •6. Signed and dated written informed consent in accordance with Good Clinical
- •Practice (GCP) and local legislation.
排除标准
- •1. Diagnosed with Type 1 Diabetes or with a history of ketoacidosis
- •2. Subject that use insulin of are unwilling/unable to discontinue SUs
- •3. A positive Anti-GAD test, as an indication of type 1 diabetes mellitus or
- •Latent Autoimmune Diabetes of the Adult (LADA) with progressive beta-cell loss.
- •4. Previous GI surgery that could affect the ability to treat the duodenum such
- •as subjects who have had a Bilroth2, Roux-en-Y gastric bypass, or other similar
- •5. History of chronic or acute pancreatitis
- •6. Known active hepatitis or active liver disease
- •7. Symptomatic gallstones or kidney stones, acute cholecystitis or history of
- •duodenal inflammatory diseasesincluding Crohn*s Disease and Celiac Disease
- •8. Use of anticoagulation therapy (such as warfarin, coumadin, novel oral
- •anticoagulants [NOAC]) or anti-platelet agents (such as thienopyridine) which
- •cannot be discontinued for 5-7 days or 2 drug half-lives before the procedure
- •or stopped according to local portocol. Acetylsalicylic acid does not need to
- •be discontinued.
研究者
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