2024-519903-88-00招募中2 期
A Phase II, randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of oral controlled-ileal-release nicotinic acid (CIR-NA) for inducing remission in subjects with prediabetes
Universitaetsklinikum Schleswig-Holstein AöR2 个研究点 分布在 1 个国家目标入组 390 人开始时间: 2025年8月19日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 390
- 试验地点
- 2
- 主要终点
- Remission of prediabetes at week 26
研究概览
简要总结
The primary objective is to assess the efficacy of CIR-NA on the remission of prediabetes at week 26.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Male and female participants ≥ 18 to < 80 years of age
- •Body mass index ≥ 20 kg/m²
- •Diagnosed prediabetes according to the current EASD/DDG guidelines
排除标准
- •Presence or a history of type 2 diabetes mellitus according to the current EASD/DDG guidelines
- •Renal impairment (glomerular filtration rate <60 ml/min/1.73)
- •Impairment of hepatic function (one or more of liver enzymes alanine transaminase, aspartate transaminase and gamma glutamyl transferase [> 3-fold compared to normal range])
- •Current infection with hepatitis B or C
- •Current or history of malignancy except for completely resected basal cell carcinoma and squamous cell carcinoma of the skin
- •Use of antibiotics (systemic or gut-acting [non-absorbed]) within 8 weeks prior to the first dose of IMP
- •Pregnant or breastfeeding women
- •Long term use of higher doses of proton pump inhibitors, targeted H2-receptor antagonists or antacid formulations (i.e., doses equivalent to > 40 mg pantoprazole per day)
结局指标
主要结局
Remission of prediabetes at week 26
Remission of prediabetes at week 26
次要结局
- Progression of prediabetes to type 2 diabetes mellitus at week 26
- Fasting plasma glucose levels at week 26
- Glycated haemoglobin (HbA1c) levels at week 26
- 2-h oral Glucose Tolerance Test levels at week 26
研究者
Office Prof. Stefan Schreiber
Scientific
Universitaetsklinikum Schleswig-Holstein AöR
研究点 (2)
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