KCT0004073已完成未知
Quadruple oral combination therapy for type 2 diabetes mellitus : Glycemic control by Thiazolidinedione (TZD) or Sodium glucose co-transporter 2 (SGLT2) inhibitor as an add-on therapy in type 2 diabetes mellitus after failure of an oral triple antidiabetic regimen
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 121
研究概览
简要总结
After 24 week-quadruple treatment, all groups demonstrated significant reductions in HbA1c [from 7.94±0.74 to 6.97±0.84% in the SGLT2 inhibitor group (adding SGLT2 inhibitor to metformin, sulfonylurea and DPP-4 inhibitor) and 8.00±0.78 to 7.18±0.98% in the Thiazolidinedione (TZD) group (adding TZD to metformin, sulfonylurea and DPP-4 inhibitor)], without a significant between-group difference (p=0.235). A significant body mass index reduction was noted in the SGLT2 inhibitor group, whereas an increase in BMI was noted in the TZD group (-0.79 ± 1.37 vs. 0.92 ± 0.86, p<0.001). Other safety profiles were favorable in both groups.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •1. 19 = age = 80, male or female
- •2. Type 2 diabetes patients who have taken triple combination therapy of OADs as followed : Metformin (=1000 mg/day), Sulfonylurea (Glimepiride = 4 mg/day or Gliclazide = 60 mg/day), DPP-4 inhibitor (Full dose) for over 12 weeks
- •3. At screening, 7% < HbA1c = 10%
- •4. Patients who refused insulin therapy.
- •5. Subjects who understood the contents of the clinical trial and are cooperative in the trial progress, and are considered to be able to participate until the end of the trial.
- •6. Patients who have voluntarily agreed in writing to participate in the clinical trial after hearing the explanation of the trial.
排除标准
- •1. Type 1 diabetes, gestational diabetes, and other types of diabetes than type 2 diabetes mellitus.
- •2. Patients who have the history of allergy of hypersensitivity for the medication of the clinical trial.
- •3. Patients who have the history of taking TZDs or SGLT-2 inhibitors within a year prior to screening visit, or have the history of discontinuation of them due to severe side effects.
- •4. Patients who have the history of acute or chronic metabolic acidosis including diabetic ketoacidosis (with or without coma), or any kinds of ketosis within 12 weeks prior to screening visit.
- •5. Patients who have genetic metabolic diseases, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsoption
- •6. Patients who have the history of taking steroids for more than 2 weeks, within 8 weeks prior to screening visit.
- •7. Patients who have the history of malignancy within 5 years prior to screening visit (In case of bladder cancer, subjects will be excluded regardless of the time of diagnosis)
- •8. Patients who have the history of coronary artery bypass surgery or percutaneous coronary intervention, or suffered from heart failure (NYHA class III, IV)
- •9. Patients who have the history of uncontrolled arrhythmia, unstable angina, myocardial infarction, stroke, transient ischemic attacts, and cerebral vascular disease within 24 weeks prior to the screening date.
- •10. Patients of chronic renal failure, chronic kidney disease stage 3~5 (estimated glomerular filtration rate calculated vial CKD-EPI <60 mL/min/1.73m2) or on dialysis therapy.
- •11. Elevated liver enzymes (AST, ALT, ALP = 2.5*upper limit of normal (ULN) or Total bilirubin = 2.5*ULN) or Child-Pugh class B or C (for the patients of liver cirrhosis)
- •12. Subjects who are pregnant or lactating
- •13. Perioperative patients, patients with severe infections or severe trauma
- •14. Patients with unexamined gross hematuria
- •15. Any other subjects who is determined to be ineligible for the clinical trials by researchers.
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