NCT04979130已完成4 期
A Randomized Parallel Comparison of Semaglutide Versus Placebo on Intestinal Barrier Function in Type 2 Diabetes Mellitus (SIB)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Differences in lactulose mannitol ratio (LMR) test as a measure of intestinal permeability between treatment groups
研究概览
简要总结
This study plans to learn more about the effect of semaglutide once weekly on intestinal permeability in individuals with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial, except for protocol described pre-screening activities, which require a separate informed consent.
- •Male or female, age above or equal to 18 years at the time of signing informed consent.
- •Diagnosed with type 2 diabetes mellitus on metformin monotherapy
- •Hemoglobin A1c <8.0% (<64 mmol/mol) on screening day
- •Body mass index (BMI) ≥28 kg/m2
- •Low-grade inflammation, defined as elevated high sensitivity C-reactive protein (hs- CRP >1.0 and ≤10 mg/L). Impaired intestinal barrier function results in activation of inflammatory pathway; therefore, excluding subjects with no evidence of inflammation (hs-CRP ≤ 1 mg/L) will help to enrich our study population. Similar threshold for hs-CRP as a marker of "residual inflammatory risk" (29) has been previously used as an independent predictor of future vascular events (26, 30).
排除标准
- •Known or suspected hypersensitivity to trial product or related products.
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child- bearing potential and not using a highly effective contraceptive method.
- •Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening.
- •Any disorder, which in the investigator's opinion might jeopardize patient's safety or compliance with the protocol.
- •Any of the following: myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischemic attack (TIA) within the past 60 days prior to the day of screening.
- •Second anti-diabetic agent use within 3 months of screening.
- •Chronic kidney disease defined as eGFR < 30 mL/min/1.73 m
- •C-reactive protein (hs-CRP >10.0 mg/L) to eliminate patients with acute inflammatory process at the time of screening.
- •Any recent infection or antibiotic use within 3 weeks
- •Regular use (more than a week duration) of anti-inflammatory medication (steroid or NSAIDs) within 3 months of screening.
- •Regular use (more than a week duration) of any digestive health supplements, such as probiotics or prebiotics within 3 months screening.
- •Diagnosis of chronic intestinal inflammatory disease such as Crohn's disease, ulcerative colitis or irritable bowel syndrome.
- •Prior bariatric or bowel surgery
- •Heart failure presently classified as being in New York Heart Association (NYHA) Class IV.
- •Presence or history of malignant neoplasm within 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.
- •Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma (MTC).
- •History of chronic pancreatitis or history of acute pancreatitis within 6 months of screening.
- •Chronic consumption of > 2 alcoholic standard drinks per day as defined by:
- •12 ounces of beer (5% alcohol content).
- •8 ounces of malt liquor (7% alcohol content).
- •5 ounces of wine (12% alcohol content).
- •1.5 ounces or a "shot" of 80-proof (40% alcohol content) distilled spirits or liquor (e.g., gin, rum, vodka, whiskey).
研究组 & 干预措施
SC semaglutide
Experimental
Participants receive a once weekly, subcutaneous, Semaglutide injection for 16 weeks in addition to the participants background metformin monotherapy. The participants in this arm will begin at a 0.25 mg dose during the randomization visit, at week 4 this will be escalated to a 0.5 mg dose and at week 8 it will be escalated again to a 1.0 mg dose if tolerable by the participant. If the participant cannot tolerate the 0.25 mg dose at randomization or the 0.5 mg dose at week 4 they will be withdrawn from the study.
干预措施: Semaglutide (Drug)
Placebo
Placebo Comparator
Participants in this arm will be given a once weekly, subcutaneous, placebo injection matching the Semaglutide experimental arm in addition to their background metformin monotherapy.
干预措施: Placebo (Drug)
结局指标
主要结局
Differences in lactulose mannitol ratio (LMR) test as a measure of intestinal permeability between treatment groups
时间窗: Week 16 (visit 6)
The ratio of lactulose to mannitol will be measured in urine collected within 6 hours after ingestion of dual sugar. This ratio predominantly reflects small intestine permeability.
次要结局
- Differences between treatment groups in plasma IL-8(Week 8 (visit 4), Week 16 (visit 6))
- Differences between treatment groups in plasma LBP(Week 8 (visit 4), Week 16 (visit 6))
- Differences between treatment groups in Serum zonulin(Week 8 (visit 4), Week 16 (visit 6))
- Differences between treatment groups in Fecal Calprotectin(Week 8 (visit 4), Week 16 (visit 6))
- Differences between treatment groups in plasma IL-6(Week 8 (visit 4), Week 16 (visit 6))
- Differences between treatment groups in plasma TNFα(Week 8 (visit 4), Week 16 (visit 6))
- Differences between treatment groups in plasma hs-CRP(Week 8 (visit 4), Week 16 (visit 6))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Research Study Comparing Different Tablets With the Study Medicine Semaglutide in Healthy MenDiabetes Mellitus, Type 2NCT03638778Novo Nordisk A/S105
已完成
1 期
A Clinical Trial Looking at the Comparability of 2 Different Forms of SemaglutideHealthy Volunteers (Diabetes Mellitus, Type 2)NCT05232708Novo Nordisk A/S18
已完成
1 期
A Research Study Looking at the Comparability (Bioequivalence) of Two Versions of SemaglutideHealthy VolunteersOverweightObesityNCT04228354Novo Nordisk A/S28
已完成
3 期
A Research Study to Look Into How Semaglutide, Together With a Lower Dose of Insulin Glargine, Compares to a Higher Dose of Insulin Glargine Alone in People With Type 2 Diabetes (SUSTAIN OPTIMIZE)ObesityDiabetes Mellitus, Type 2NCT05514535Novo Nordisk A/S573
尚未招募
3 期
Efficacy and Safety of Semaglutide Injection in Subjects With Type 2 DiabetesType 2 Diabetes MellitusNCT06339086Chengdu Brilliant Pharmaceutical Co., Ltd.478