DM Treatment to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone in Patients with Type 2 Diabetes

Официальное название

Key Finding of DM Treatment with Combination, a MuLticenter, Randomized, Parallel, Gathering Information of Phase 4 Trial to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone Add-on to Metformin and DPP-4 Inhibitor in Patients with Type 2 Diabetes

Обзор

Key finding of DM Treatment with combination, A MuLticenter, Randomized, Parallel, Gathering Information of phase 4 Trial to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone add-on to Metformin and DPP-4 inhibitor in Patients with Type 2 Diabetes Who Have Inadequate Glycaemic Control on a Background Combination of Metformin and DPP-4 inhibitor(KLIMT Study)

Подробное описание

This is a Phase 4, multicenter, randomized, open-label, parallel clinical trial

Вмешательства

• Препарат DW6012(Dasidiem tab. 10/100mg)
  Once a day, Oral administration

Первичные конечные точки

• Variance in HbA1c from baseline to 24 weeks on study drug [Срок оценки: 24 weeks]

Вторичные конечные точки (12)

• Variance in HbA1c from baseline to 12 weeks on study drug [Срок оценки: 12 weeks]
• Variance in FPG from baseline to 12, 24 weeks on study drug [Срок оценки: 12, 24 weeks]
• Variance in TC(mg/dL), TG(mg/dL), HDL(mg/dL), LDL(mg/dL) from baseline to 12, 24 weeks on study drug [Срок оценки: 12, 24 weeks]
• Variance in FLI(Fatty Liver Index), AST, ALT, r-GTP, ALP, HSI(Hepatic steatosis index), Total bilirubin, Albumin, Protein from baseline to 12 and 24 weeks after study drug administration [Срок оценки: 12, 24 weeks]
• Variance in Kidney value from baseline to 12, 24 weeks on study drug [Срок оценки: 12, 24 weeks]
• Variance in body weight from baseline to 12, 24 weeks on study drug [Срок оценки: 12, 24 weeks]
• Percentage of patients achieving HbA1c of 7.0% or 6.5% or less at 12 and 24 weeks post study drug administration compared to baseline [Срок оценки: 12, 24 weeks]
• Variance in Insulin from baseline to 12, 24 weeks on study drug [Срок оценки: 12, 24 weeks]
• Percentage of subjects prescribed an rescue drug during this study [Срок оценки: during 24weeks(study duration/per subject)]
• Variance in waist measurement from baseline to 12, 24 weeks on study drug [Срок оценки: 12, 24 weeks]
• Variance in BMI from baseline to 12, 24 weeks on study drug [Срок оценки: 12, 24 weeks]
• Variance in blood pressure from baseline to 12, 24 weeks on study drug [Срок оценки: 12, 24 weeks]

Критерии участия

Критерии включения

• Patients with type 2 diabetes who are 19 years of age or older at the date of written consent
• Subjects who Receiving a stable dose of metformin and a DPP-4 inhibitor for at least the last 8 weeks at the time of screening
• HbA1c ≤ 7.0% ≤ HbA1c < 10% at time of screening
• BMI ≤ 18.5 kg/m2 ≤ 40 kg/m2 at time of screening
• Subjects fully explained and understood the purpose and methods of this study and voluntarily gave written informed consent

Критерии исключения

• Patients with type 1 diabetes
• Have a BMI > 40 kg/m2
• Subjects who have moderate (Stage 3b) or severe kidney disease or an estimated glomerular filtration rate (eGFR, using the CKD-EPI formula) < 45 mL/min/1.73 m2
• Patients with end stage renal disease or patients on dialysis
• Patients with uncontrolled heart failure (NYHA class III - IV)
• Patients with history of uncontrolled arrhythmia, myocardial infarction, unstable angina, coronary artery bypass graft surgery, cerebrovascular disease within 24 weeks prior to the screening visit
• Patients with acute or chronic metabolic acidosis, including lactic acidosis, diabetic ketoacidosis (DKA) with or without coma, and patients with a history of ketoacidosis
• Patients with diabetic coma or precoma
• Patients with a history of severe hypoglycemia while taking metformin and DPP-4 inhibitors.
• Patients with hematuria
• Patients who receiving treatment for thyroid dysfunction at the time of screening
• Malnourished, starving, or debilitated subjects
• Patients with pituitary insufficiency or adrenal insufficiency
• Patients with clinically significant hepatic disease with AST or ALT greater than 3 times the upper limit of normal
• Patients with severe infectious diseases, perioperative, or clinically significant trauma
• Have a history of substance abuse
• Patients receiving insulin or sulfonylurea, thiazolidinedione, SGLT2 inhibitor, GLP-1 receptor agonist within 8 weeks prior to the screening visit
• Patients who have received more than 2 consecutive weeks of corticosteroids within 8 weeks at the time of screening or who require treatment requiring repeated use of corticosteroids
• Patients with a history of malignancy within the last 5 years
• Participation in any other clinical trial within 12 weeks of screening in which an investigational drug or investigational medical device was administered or applied
• Pregnant and breastfeeding women
• Hypersensitivity to any of the drugs and components, including metformin, DPP-4 inhibitors, dapagliflozin, TZDs, sulfonylurea class of drugs, or any of the ingredients
• Patients with genetic problems such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose mal-absorption.
• Any other person deemed by the investigator to be unsuitable for participation in the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

South Korea · 1 центр

• Kyung Hee University Hospital at Gangdong — Seoul

Идентификаторы

NCT: NCT06875193 · DW6012-IV-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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