NCT06875193招募中4 期
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
Dong Wha Pharmaceutical Co. Ltd.1 个研究点 分布在 1 个国家目标入组 196 人开始时间: 2024年5月28日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Variance in HbA1c from baseline to 24 weeks on study drug
研究概览
简要总结
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)
详细描述
This is a Phase 4, multicenter, randomized, open-label, parallel clinical trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Dasidiem 10/100mg
Experimental
Dapagliflozin 10mg +sitagliptin 100mg combination drug
干预措施: DW6012(Dasidiem tab. 10/100mg) (Drug)
sitdiem 100mg, Piotazone15mg
Active Comparator
sitagliptin 100mg, Pioglitazone 15mg
干预措施: DW6012(Dasidiem tab. 10/100mg) (Drug)
结局指标
主要结局
Variance in HbA1c from baseline to 24 weeks on study drug
时间窗: 24 weeks
Change in HbA1c
次要结局
- Variance in HbA1c from baseline to 12 weeks on study drug(12 weeks)
- Variance in FPG from baseline to 12, 24 weeks on study drug(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(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(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(12, 24 weeks)
- Variance in Insulin from baseline to 12, 24 weeks on study drug(12, 24 weeks)
- Variance in Kidney value from baseline to 12, 24 weeks on study drug(12, 24 weeks)
- Variance in body weight from baseline to 12, 24 weeks on study drug(12, 24 weeks)
- Percentage of subjects prescribed an rescue drug during this study(during 24weeks(study duration/per subject))
- Variance in waist measurement from baseline to 12, 24 weeks on study drug(12, 24 weeks)
- Variance in BMI from baseline to 12, 24 weeks on study drug(12, 24 weeks)
- Variance in blood pressure from baseline to 12, 24 weeks on study drug(12, 24 weeks)
- Variance in HOMA-IR, HOMA-β(Glucose in Molar Units mmol/L) from baseline to 12, 24 weeks on study drug(12, 24 weeks)
- Variance in c-peptide from baseline to 12, 24 weeks on study drug(12, 24 weeks)
研究者
研究点 (1)
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