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临床试验 NCT06613854 (E-SEMPA) 针对2型糖尿病 (T2DM)目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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卡片视图
Effect of Early Combination Antihyperglycemic Treatment on Metabolic Control in Individuals With Type 2 Diabetes (E-SEMPA) IV期 90
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临床试验NCT06613854 (E-SEMPA)旨在研究治疗，主要针对2型糖尿病 (T2DM)。这是一项IV期 干预性研究试验，目前试验状态为招募中。试验始于2024年10月1日，计划招募90名患者。该研究由University Medical Centre Ljubljana主导，预计于2027年12月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2024年10月17日。
简要概括
The goal of this clinical trial is to learn if early combination with two antidiabetic drugs further improves blood glucose control compared to a single drug regimen in adults with short duration of type 2 diabetes. It will also learn about the effect of the combination treatment on body weight, body composition, blood lipids, oxidative stress, inflammation, metabolic control, insulin resistance and insulin secretion...显示更多
详细描述
Type 2 diabetes (T2D) is a progressive chronic disease and represents a significant risk factor for morbidity and mortality due to cardiovascular disease. In addition to managing glycemia, the use of antihyperglycemic medications with further and independent cardiovascular benefits is recommended in managing individuals with T2D. These medications primarily include sodium-glucose cotransporter 2 inhibitors (SGLT2i) a...显示更多
官方标题
Effect of Early Combination Antihyperglycemic Treatment With Metformin and Oral Semaglutide vs. Metformin and Empagliflozin on Glycemic and Metabolic Control in Individuals With Short Duration Type 2 Diabetes
疾病
2型糖尿病 (T2DM)其他研究标识符
- E-SEMPA
- 0120-70/2024-2711-3 (其他标识符) (National Medical Ethics Committee of the Republic of Slovenia)
NCT编号
实际开始日期
2024-10-01
最近更新发布
2024-10-17
预计完成日期
2027-12
计划入组人数
90
研究类型
干预性研究
试验分期 (阶段)
IV期
试验状态
招募中
关键词
E-SEMPA
Early Combination Antihyperglycemic Treatment
Metformin
Semaglutide
Empagliflozin
Glycemic Control
Metabolic Control
Type 2 Diabetes
Insulin Resistance
Time in Range
CGM
Continuous Glucose Monitoring
UMC Ljubljana
Early Combination Antihyperglycemic Treatment
Metformin
Semaglutide
Empagliflozin
Glycemic Control
Metabolic Control
Type 2 Diabetes
Insulin Resistance
Time in Range
CGM
Continuous Glucose Monitoring
UMC Ljubljana
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
阳性对照Oral Semaglutide Arm Participants will receive oral semaglutide in addition to metformin (in a steady daily dose of ≥1500 mg), starting with an initial dose of 3 mg. The dose of semaglutide will be increased to 7 mg after 30 days, and then to a maintenance dose of 14 mg once daily after another 30 days that will be continued to week 26. In the case of inadequately controlled glycemia (HbA1c \>8.0 % or symptomatic hyperglycemia), rescue t...显示更多 | Oral semaglutide Semaglutide Oral Tablets will be introduced to the Oral Semaglutide Arm as per protocol for regular therapy introduction. |
阳性对照Empagliflozin Arm Participants will receive oral empagliflozin in a once daily dose of 10 mg in addition to metformin (in a steady daily dose of ≥1500 mg). The dose of empagliflozin will not be subsequently changed during the duration of the study. In the case of inadequately controlled glycemia (HbA1c \>8.0 % or symptomatic hyperglycemia), rescue treatment with gliclazide will be initiated. | Empagliflozin 10 mg Empagliflozin Oral Tablets will be introduced to the Empagliflozin Arm as per protocol for regular therapy introduction. |
无干预Control Arm Participants will receive metformin in a steady daily dose of ≥1500 mg. In the case of inadequately controlled glycemia (HbA1c \>8.0 % or symptomatic hyperglycemia), rescue treatment with gliclazide will be initiated. | 不适用 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Time in Range (TIR) | Defined as the time (or percentage of measurements) when the glucose value in the interstitial fluid is in the range of 3.9-10.0 mmol/L. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes). | Period of 14 days prior to last study visit (week 26) |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Absolute Change in Time in Range (TIR) | Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes). | Baseline (week 0) and last study visit (week 26) |
Absolute Change in Glycated hemoglobin (HbA1c) | Assessment by biochemical methods (in %) | Baseline (week 0) and last study visit (week 26) |
Time above Range (TAR) | Defined as the time (or percentage of measurements) when the glucose value in the interstitial fluid is above 10.0 mmol/L. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes). | Last study visit (week 26) |
Time below Range (TBR) | Defined as the time (or percentage of measurements) when the glucose value in the interstitial fluid is below 3.9 mmol/L. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes). | Last study visit (week 26) |
Time above Range (TAR) - Level 1 Hyperglycemia | Defined as the time (or percentage of measurements) when the glucose value in the interstitial fluid is in the range of 10.1-13.9 mmol/L. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes). | Last study visit (week 26) |
Time above Range (TAR) - Level 2 Hyperglycemia | Defined as the time (or percentage of measurements) when the glucose value in the interstitial fluid is above 13.9 mmol/L. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes). | Last study visit (week 26) |
Time below Range (TBR) - Level 1 Hypoglycemia | Defined as the time (or percentage of measurements) when the glucose value in the interstitial fluid is in the range of 3.0-3.8 mmol/L. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes). | Last study visit (week 26) |
Time below Range (TBR) - Level 2 Hypoglycemia | Defined as the time (or percentage of measurements) when the glucose value in the interstitial fluid is below 3.0 mmol/L. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes). | Last study visit (week 26) |
Time in Tight Range (TITR) | Defined as the time (or percentage of measurements) when the glucose value in the interstitial fluid is in the range of 3.9-7.8 mmol/L. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes). | Last study visit (week 26) |
Coefficient of variation (CV) | A measure of dynamic glucose variability. Calculated as a ratio of glucose concentration standard deviation and mean glucose concentration, expressed as a percentage. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in %). | Last study visit (week 26) |
Mean Time in Range (TIR) | Mean Time in Range (TIR) at study visit at week 13 and week 26. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes). | Study visit at week 13 and week 26 |
Mean glucose concentration | Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in mmol/L). | Last study visit (week 26) |
Proportion of participants with Coefficient of variation (CV) below or equal to 36% | Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in %). | Last study visit (week 26) |
Standard deviation of mean glucose concentration | Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in mmol/L). | Last study visit (week 26) |
Proportion of participants with Time in Range (TIR) above 70% | Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in %). | Last study visit (week 26) |
Proportion of participants with Time in Range (TIR) above 90% | Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in %). | Last study visit (week 26) |
Proportion of participants with Glycated hemoglobin (HbA1c) below 6.5% | Assessment by biochemical methods (in %) | Last study visit (week 26) |
Proportion of participants with Glycated hemoglobin (HbA1c) below 5.7% | Assessment by biochemical methods (in %). | Last study visit (week 26) |
Proportion of participants requiring rescue therapy with gliclazide | Measured in %. | Baseline (week 0) to last study visit (week 26) |
Proportion of participants with severe hypoglycemia | Severe hypoglycemia is an epizode of hypoglycemia requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions. Measured in %. | Baseline (week 0) to last study visit (week 26) |
Proportion of participants with severe adverse events | Severe adverse event is defined as symptoms that significantly affects daily activities. Assessment by patients themselves. Measured in %. | Baseline (week 0) to last study visit (week 26) |
Proportion of patients withdrawing from the trial due to adverse events of the interventional drugs | Assessment by patients themselves. Measured in %. | Baseline (week 0) to last study visit (week 26) |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Diagnosed with type 2 diabetes for up to 2 years (prior to randomization);
- Aged between 18 and 70 years, both sexes, of any race or ethnicity;
- HbA1c ≤8.0% at randomization;
- Baseline treatment with metformin at a steady daily dose of ≥1500 mg;
- Signed informed consent to participate in the study.
- Treatment at any time in the past with SGLT2i, GLP-1RA, or DPP-4 inhibitors;
- Insulin treatment for longer than 2 weeks in the past;
- Body Mass Index below 22 kg/m2 or BMI above 40 kg/m2;
- Chronic kidney disease stages 3-5 (eGFR below 60 ml/min or the presence of albuminuria (urine albumin-to-creatinine ratio above 34 g/mmol);
- Known cardiovascular disease (angina pectoris, history of myocardial infarction, ischemic heart disease, heart failure, known carotid atherosclerosis, objectively proven peripheral arterial disease, or other known atherosclerotic disease at other locations);
- Moderate or severe liver disease (Child-Pugh stage B or C);
- Personal history of pancreatitis;
- Advanced heart failure (NYHA III-IV);
- Retinopathy or maculopathy or their active treatment;
- Pregnancy, expected pregnancy, or breastfeeding;
- Presence of active malignancy or personal history of malignancy within 5 years of study enrollment;
- Personal history of thyroid cancer; personal or family history of multiple endocrine neoplasia type 2 or family history of medullary thyroid carcinoma;
- Chronic inflammatory bowel disease;
- History of bariatric surgery or other gastrointestinal surgery that could affect drug or nutrient absorption;
- Frequent or severe urinary tract infections;
- Presence of a urinary catheter;
- Troublesome and recurrent genital fungal infections;
- Personal history of ketoacidosis;
- Symptomatic hypotension or predisposition to hypovolemia;
- History of organ transplantation;
- Allergy to any component in the semaglutide or empagliflozin oral tablet;
- Any medical or social circumstance that may limit participation in the study (e.g., inability to attend regular study visits);
- Any other condition that, in the opinion of the principal and responsible investigators, may affect the safety or efficacy of the treatment.
University Medical Centre Ljubljana没有联系数据。
1 位于 1 个国家/地区的研究中心
University Medical Centre Ljubljana, Diabetes Outpatient Clinic, Ljubljana, 1000, Slovenia
Jaka Sikonja, MD, 联系人, +38640778882, [email protected]
Andrej Janez, MD, PhD, 主要研究者
Urh Groselj, MD, PhD, 分研究者
Jaka Sikonja, MD, 分研究者
招募中