رادار التجارب AI | ||
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حالة التجربة السريرية NCT06613854 (E-SEMPA) لـ داء السكري النوع الثاني هي يقبل مشاركين. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
دراسة واحدة تطابق معايير الفلتر
عرض البطاقة
Effect of Early Combination Antihyperglycemic Treatment on Metabolic Control in Individuals With Type 2 Diabetes (E-SEMPA) المرحلة الرابعة ٩٠
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات الدراسة باللغة التي اخترتها.
التجربة السريرية NCT06613854 (E-SEMPA) مصممة لدراسة علاج لـداء السكري النوع الثاني. إنها دراسة تدخُّلية من المرحلة الرابعة وهي يقبل مشاركين. بدأت في ٢٨ ربيع الأول ١٤٤٦ هـ مع خطة لتجنيد ٩٠ مشاركًا. تقودها University Medical Centre Ljubljana، ومن المتوقع اكتمالها بحلول ٣ رجب ١٤٤٩ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ١٤ ربيع الآخر ١٤٤٦ هـ.
الملخص
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...عرض المزيد
وصف مفصل
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...عرض المزيد
العنوان الرسمي
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
الحالات الطبية
داء السكري النوع الثانيمعرّفات دراسة أخرى
- E-SEMPA
- 0120-70/2024-2711-3 (معرف آخر) (National Medical Ethics Committee of the Republic of Slovenia)
NCT معرّف
تاريخ البدء (فعلي)
2024-10-01
آخر تحديث مُنشور
2024-10-17
تاريخ الاكتمال (المقدر)
2027-12
عدد المشاركين المخطط لهم
٩٠
نوع الدراسة
تدخُّلية
المرحلة
المرحلة الرابعة
الحالة
يقبل مشاركين
الكلمات الرئيسية
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
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
لا شيء (تجربة مفتوحة)
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
مقارن نشطOral 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...عرض المزيد | Oral semaglutide Semaglutide Oral Tablets will be introduced to the Oral Semaglutide Arm as per protocol for regular therapy introduction. |
مقارن نشطEmpagliflozin 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. |
بدون تدخلControl 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. | غ/م |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
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) |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
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) |
مساعد المشاركة
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
- 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 Ljubljanaلا توجد بيانات اتصال.
1 مواقع الدراسة في 1 بلدان
University Medical Centre Ljubljana, Diabetes Outpatient Clinic, Ljubljana, 1000, Slovenia
Jaka Sikonja, MD, جهة اتصال, +38640778882, [email protected]
Andrej Janez, MD, PhD, المحقق الرئيسي
Urh Groselj, MD, PhD, محقق فرعي
Jaka Sikonja, MD, محقق فرعي
يقبل مشاركين