EUCTR2021-005721-25-DE进行中（未招募）1 期
SGLT2 inhibition in addition to lifestyle intervention and risk for complications in subtypes of patients with prediabetes - a randomized, placebo controlled, multi-center trial
niveristy Hospital Tuebingen0 个研究点目标入组 182 人开始时间: 2023年1月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 182
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- ••Male, female or intersexual diverse patients aged 35 and 75 years (including)
- •Patients assigned to high risk for diabetes clusters 3, 5 and 6 according to Wagner et al., 2021 who have signs of early kidney disease (urinary albumin-to-creatinine ratio (uACR) 30mg/g - 300 mg/g, CKD stage G1A2/G2A2)
- •Prediabetes (defined by one of the following: FG > 100 mg/dL, HbA1c > 5,6 or 2h OGTT glucose > 140 mg/dL)
- •BMI = 20 kg/m2
- •TSH within normal range
- •Ability to understand and follow study-related instructions
- •Negative pregnancy test for premenopausal women (blood)
- •Patients who are receiving thyroid replacement therapy must be on a stable treatment (i.e. TSH within normal range) regimen for at least 3 months prior to the screening visit (V-10)
- •Patients who are receiving antihypertensive medication such as mineralocorticoid receptor antagonists must be on a stable treatment regimen (i.e. no hospital admission due to excessive hypertension and stable dosing) for at least 6 weeks prior to the screening visit (V-10)
- •Patients who are treated with antihypertensive medication such as ACE inhibitors and AT1 receptor antagonists, thiazides as well as loop diuretics must be on stable treatment (i.e. no hospital admission due to excessive hypertension and stable dosing) for at least 2 weeks
- •Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.
- •Patients will not be included in the study if, in the opinion of the investigator, participation will lead to an unacceptable risk to the subjects’ safety or well-being
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 169
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
排除标准
- ••Manifest diabetes mellitus
- •eGFR (as calculated by the CKD-EPI equation) < 60 ml/min/1.73 m2
- •all glucose altering medications (including current therapy with dapagliflozin or empagliflozin or any other SGLT2-Inhibitor)
- •Symptomatic chronic congestive heart disease
- •New diuretic or antihypertensive medication or dosing changes within the last 2 weeks, for aldosterone antagonists within the last 6 weeks
- •known or suspected orthostatic proteinuria
- •any acute severe or chronic severe illness, including the following: malignant disease ongoing or < 5 years ago, unstable cardiovascular disease or procedure within 3 months prior to enrolment or expected to require coronary revascularisation procedure
- •history of or current therapy for congestive heart failure (NYHA III and IV), pacemaker or aortic stenosis > II°
- •acute pancreatic disease (i.e. elevated lipase 3x ULN)
- •rapidly progressing renal disease or anuria
- •known HIV infection or positive HIV test at screening
- •history of or planned organ transplantation
- •history or presence of inflammatory bowel disease or other severe gastrointestinal diseases, particularly those which may impact gastric emptying, such as gastroparesis or pyloric stenosis
- •relevant hepatic disease, including, but not limited to, acute hepatitis, chronic active hepatitis, or severe hepatic insufficiency, including patients with alanine aminotransferase and/or aspartate aminotransferase > 3 x upper limit of normal and/or total bilirubin (TB) > 2 mg/dL (> 34.2 µmol/L) (patients with TB > 2 mg/dL [> 34.2 µmol/L] and documented Gilbert’s syndrome will be allowed to participate).
- •treatment with glucocorticoids
- •antibiotic treatment within the last 4 weeks
- •History of ketoacidosis
- •history of repeated urogenital infection
- •hemoglobinopathies, haemolytic anaemia, or chronic anaemia (haemoglobin concentration < 12.0 g/dL)
- •presence of psychiatric disorder or intake of antidepressant or antipsychotic agents
- •Positive Screening for a severe depression (BDI =29)
- •history of hypersensitivity to the study drug or its ingredients
- •allergy to iodine contrast dye
- •more than 5% weight loss in the last 3 months
- •Pregnant or breastfeeding women
- •Subject (male, female or intersexualdiverse) is not willing to use highly effective contraceptive methods during treatment and for 14 days (male or female) after the end of treatment (highly effective methods are defined as: combined hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence).
- •Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the trial participant and that the vasectomized partner has received medical assessment of the surgical success.
- •Current participation in other interventional clinical trials or treatment with other IMPs within five times the half-life of the drug
- •Previous therapy with dapagliflozin or other drugs that can potentially lead to overlapping toxicities within five times the half-life of the drug
- •Patients who do not want to be informed about accidental findings
- •Any other clinical condition that would jeopardize subjects’ safety or well-being while participating in this clinical trial
- •Patients will not be included in the study if, in the opinion
研究者
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