A 24-week, multicenter, randomized, open-label, parallel group clinical study to compare the efficacy and safety of oral quadruple hypoglycemic agents including SGLT2 inhibitor and triple hypoglycemic agents including GLP-1 receptor agonist in patients with type 2 diabetes mellitus, uncontrolled with oral triple hypoglycemic agents
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Endocrine, nutritional and metabolic diseases
- Sponsor
- Yonsei University Health System, Severance Hospital
- Enrollment
- 152
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •? 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
Exclusion Criteria
- •? 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
Outcomes
Primary Outcomes
Not specified