Diabetes Metab J.  2019 Oct;43(5):590-606. 10.4093/dmj.2018.0134.

Efficacy and Safety of Sodium-Glucose Cotransporter-2 Inhibitors in Korean Patients with Type 2 Diabetes Mellitus in Real-World Clinical Practice

• Hong AR
• Koo BK
• Kim SW
• Yi KH
• Moon MK

• KMID: 2460953
• DOI: http://doi.org/10.4093/dmj.2018.0134

Abstract

BACKGROUND
This study aimed to evaluate the efficacy and safety of sodium-glucose cotransporter-2 (SGLT2) inhibitors in Korean patients who had inadequately controlled type 2 diabetes mellitus (T2DM) in real-world clinical practice.
METHODS
We included 410 patients who started SGLT2 inhibitors (empagliflozin or dapagliflozin) as add-on therapy or switch therapy between February 2015 and June 2017. The primary efficacy endpoint was a change in glycosylated hemoglobin (HbA1c) from baseline to week 12. The secondary endpoints were patients achieving HbA1c <7.0% and changes in the fasting plasma glucose (FPG), lipid profiles, body weight, and blood pressure (BP).
RESULTS
The mean HbA1c at baseline was 8.5% (8.6% in the add-on group and 8.4% in the switch group). At week 12, the mean adjusted HbA1c decreased by −0.68% in the overall patients (P<0.001), by −0.94% in the add-on group, and by −0.42% in the switch group. Significant reductions in FPG were also observed both in the add-on group and switch group (−30.3 and −19.8 mg/dL, respectively). Serum triglyceride (−16.5 mg/dL), body weight (−2.1 kg), systolic BP (−4.7 mm Hg), and diastolic BP (−1.3 mm Hg) were significantly improved in the overall patients. Approximately 18.3% of the patients achieved HbA1c <7.0% at week 12. A low incidence of hypoglycemia and genital tract infection was observed (6.3% and 2.2%, respectively).
CONCLUSION
SGLT2 inhibitors can be a suitable option as either add-on or switch therapy for Korean patients with inadequately controlled T2DM.

Keyword

Blood glucose; Diabetes mellitus, type 2; Hypoglycemia; Sodium-glucose transporter 2

MeSH Terms

Blood Glucose
Blood Pressure
Body Weight
Diabetes Mellitus, Type 2*
Fasting
Hemoglobin A, Glycosylated
Humans
Hypoglycemia
Incidence
Reproductive Tract Infections
Sodium-Glucose Transporter 2
Triglycerides
Blood Glucose
Sodium-Glucose Transporter 2

Figure

• 

  Fig. 1 Flow diagram of study subjects. SGLT2i, sodium-glucose cotransporter-2 inhibitor; HbA1c, glycosylated hemoglobin; OAD, oral anti-diabetic drug; MET, metformin; SU, sulfonylurea; DPP4i, dipeptidyl peptidase 4 inhibitor; TZD, thiazolidinedione.

• 

  Fig. 2 Percentage of patients who achieved glycosylated hemoglobin (HbA1c) <7.0% in overall patients and those with baseline HbA1c <8.0%. aP<0.05 between add-on therapy and switch therapy.

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