Efficacy and safety of empagliflozin as add‐on to insulin in Japanese patients with type 2 diabetes: A randomized, double‐blind, placebo‐controlled trial

Abstract

Aim To assess the efficacy and safety of empagliflozin as add‐on to insulin in Japanese patients with type 2 diabetes (T2D). Materials and methods This multicentre, double‐blind, parallel‐group study randomized Japanese patients with T2D insufficiently controlled with insulin (1:1:1) to empagliflozin 10 mg (n=89), empagliflozin 25 mg (n=90) or placebo (n=90) for 52 weeks. The primary endpoint was change from baseline in glycated haemoglobin (HbA1c) at 16 weeks. Results At 16 weeks, empagliflozin 10 mg and 25 mg significantly decreased HbA1c: adjusted mean difference −0.92% (95% confidence interval [CI] −1.11, −0.73) and −1.00% (95% CI −1.18, −0.82; both P<0.0001) compared with placebo. This difference was maintained up to 52 weeks: adjusted mean difference at 52 weeks −0.90% (95% CI −1.09, −0.70) and −0.96% (95% CI −1.15, −0.77; both P<0.0001). At 52 weeks, significant improvements in fasting plasma glucose (adjusted mean difference −27.62 mg/dL [95% CI −36.15, −19.08] and −31.99 mg/dL [95% CI −40.35, −23.62]) and in body weight (−1.78 kg [95% CI −2.46, −1.10] and −1.92 kg [95% CI −2.58, −1.25]) were also seen with empagliflozin 10 mg and 25 mg compared with placebo (all P<0.0001). At 52 weeks, the frequency of adverse events (AEs) and serious AEs was similar in the three treatment groups; confirmed hypoglycaemia was reported slightly more in participants in the empagliflozin 10 mg and 25 mg groups (23.3% and 22.2% vs 14.4%). All hypoglycaemic events were mild in severity; no episodes required assistance. Conclusions In Japanese patients with insufficiently controlled T2D, adding empagliflozin 10 mg or 25 mg to insulin treatment was associated with clinically meaningful reductions in HbA1c at 16 weeks and was generally well tolerated.

Efficacy and Safety of Empagliflozin in Type 2 Diabetes Mellitus Saudi Patients as Add-On to Antidiabetic Therapy: A Prospective, Open-Label, Observational Study

“…These findings are in line with those of another study that found that 12-week treatment with EMPA monotherapy resulted in similar reductions in HbA1c, FPG, and body weight compared to a placebo in drug-free patients with T2DM [ 40 ]. Reductions in HbA1c, FPG, and body weight were also consistent with those reported from 12-week studies on other SGLT2 inhibitors [ 33 , 41 , 42 ]. EMPA as an added therapy to insulin resulted in a significant reduction in insulin units, consistent with the results reported by [ 43 ].…”

“…Several studies have reported the safety and efficacy of EMPA for T2DM [ 11 , 33 , 34 , 35 ]. EMPA was the first in class to not only demonstrate safe SGLT2 inhibition but also cardio- and reno-protective effects in an adequately powered cardiovascular outcome trial [ 36 ].…”

Clinical Benefit of Switching from Low-Dose to High-Dose Empagliflozin in Patients with Type 2 Diabetes

“…The results of randomized clinical trials using empagliflozin are summarized in Table 5. Several trials [12][13][14][15][16][17][18][19][20][21][22][23][24] have shown significant reductions of HbA1c and BW with empagliflozin. Increasing the empagliflozin dose from 10 to 25 mg consistently caused a further reduction in HbA1c (13/16 trials, see Table 5).…”

Sodium‐Glucose Cotransporter 2 Inhibitors, All‐Cause Mortality, and Cardiovascular Outcomes in Adults with Type 2 Diabetes: A Bayesian Meta‐Analysis and Meta‐Regression

“… References 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 …”