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 regime
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0004073
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 121
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.
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean difference of HbA1c after 24 week-treatment
- Secondary Outcome Measures
Name Time Method Percentage of patients who achieve target HbA1c level (%);Mean difference of blood glucose after 24 week-treatment;Parameters associated with safety (incidence of adverse events, change of renal function and liver function)