A 24-week study to compare efficacy and safety of oral quadruple hypoglycemic agents including SGLT2 inhibitors and triple hypoglycemic agents including GLP-1 receptor agonist in patients with type 2 diabetes uncontrolled with oral triple hypoglycemic agents
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0006157
- Brief Summary
Aims: To compare the effectiveness and safety of empagliflozin and dulaglutide in patients with type 2 diabetes (T2D) inadequately controlled by oral triple therapy. Methods: In this 24-week, multi-center, randomized trial, patients with T2D and HbA1c level =7.5% (58 mmol/mol) on metformin, sulfonylurea, and dipeptidyl peptidase 4 inhibitor (DPP4-i) were randomly assigned into two groups: daily empagliflozin add-on or once-weekly dulaglutide switched from DPP4-i. The primary endpoint was changes from baseline HbA1c at 24 weeks. Results: In total, 152 patients were recruited to the empagliflozin-added quadruple group (n = 76) or the switched-to-dulaglutide triple group (n = 76). At week 24, both groups showed significant reduction in HbA1c level from baseline with greater reduction with empagliflozin (the mean treatment difference: -0.27% [95% CI -0.50 to -0.04, p = 0.024]) (-2.88 mmol/mol [95% CI -5.37 to -0.39], p = 0.024). Empagliflozin significantly reduced body weight from baseline to week 24 (-1.72 kg [95% CI -1.98 to -0.59, p < 0.001]). No serious adverse events were reported with either empagliflozin or dulaglutide. Conclusions: Empagliflozin, compared with once-weekly dulaglutide switched from DPP4-i, demonstrated greater HbA1c reduction and weight loss in patients with T2D inadequately controlled with metformin, sulfonylurea, and DPP4-i.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 152
? Men or women aged 19 to 75 years old
? Treated with sufficient dose of Metformin (1000 mg/day or more), Sulfonylurea (Glimepiride 4 mg/day or more or Gliclazide 60 mg/day or more), and DPP-4 inhibitor (taken as a daily fixed dose) combination for 12 weeks or more
? Patients with relatively poor blood sugar control with HbA1c = 7.5% at the time of screening
? BMI = 18.5 kg/m2
? Patients who were recommended for insulin treatment by their doctor, but refused
? Those who understand the contents of the clinical trial, are cooperative with the trial, and are judged to be able to participate until the end of the clinical trial
? A person who voluntarily agreed ton informed consent form to participate in the clinical trial after hearing the explanation of this clinical trial
? Diabetes patients other than type 2 diabetes, including type 1 diabetes and gestational diabetes
? Patients with hypersensitivity reaction to the main ingredients and components of this drug
? Persons with a history of discontinuing GLP-1 receptor agonists or SGLT-2 inhibitory drugs due to serious side effects prior to the screening visit
? Those with acute or chronic metabolic acidosis including diabetic ketoacidosis, or ketosis for any cause within 12 weeks of screening
? Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsoption.
? Patients receiving chronic oral or parenteral steroid treatment within 8 weeks before screening test (more than 14 consecutive days)
? People with severe renal disease: eGRF (CKD-EPI) <45 ml/min/1.73 m2
*eGFR (CKD-EPI) = 141 x min (creatinine/k, 1)a x max (creatinine/k, 1) -1.209 x 0.993Age x 1.018 (if female)
? If there is hematuria on the naked eye that has not been tested
? Patients with severe liver disease or when AST/ALT has risen more than three times the upper limit of normal
? Those who have been diagnosed with a malignant tumor within the last 5 years and have not completed treatment (but carcinoma in situ is allowed), provided that patients with properly controlled basal cell carcinoma, squamous cell skin cancer, cervical epithelial cancer, or thyroid cancer can participate.
? Those who have been hospitalized for uncontrolled arrhythmia, unstable angina, myocardial infarction, stroke, cerebrovascular disease within 24 weeks of screening
? Those who have serious infections or trauma, or are scheduled for surgery within 6 months
? Organ transplant recipients or those who need to administer long-term immunosuppressants
? Those who plan to become pregnant during the clinical trial or do not agree to appropriate contraception
? Pregnant or lactating women
? Any other investigator who determines that participation in the clinical trial is not appropriate
? Those who participated in other clinical trials within 60 days of screening (excluding observational studies)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in HbA1c from basline over 24 weeks
- Secondary Outcome Measures
Name Time Method Changes in fasing plasma glucose from basline over 24 weeks;Changes in fasing insulin, HOMA-IR, and HOMA beta from basline over 24 weeks;frequency of hypoglycemic events over 24 weeks;Changes in body weight from basline over 24 weeks;Changes in cardio-metabolic markers from basline over 24 weeks;Drug compliance;Safety assessment