Effect of switching from pioglitazone to the sodium glucose co‐transporter‐2 inhibitor dapagliflozin on body weight and metabolism‐related factors in patients with type 2 diabetes mellitus: An open‐label, prospective, randomized, parallel‐group comparison trial

Abstract

The effects of dapagliflozin (DAP) and pioglitazone (PIO) on body weight and glycaemic control were compared in patients with type 2 diabetes mellitus. Seventy‐one patients on PIO were either switched to DAP (n = 36) at 5 mg per day or continued on PIO (n = 35). Primary endpoints were superiority of body weight loss and non‐inferiority of HbA1c level after 24 weeks with DAP. Body weight decrease was greater with DAP than with PIO (75.3 ± 14.9 to 71.3 ± 15.1 kg vs. 74.7 ± 13.8 to 75.2 ± 13.9 kg; P < 0.01). Change in the HbA1c level was comparable ( P = 0.64). The level of N‐terminal prohormone of brain natriuretic peptide (NT‐proBNP) and urinary albumin : creatinine ratio (ACR) decreased only with DAP (NT‐proBNP, P < 0.01; ACR, P = 0.02), and the change in NT‐proBNP correlated negatively with baseline NT‐proBNP level (ρ = −0.68, P < 0.01) and log‐converted ACR (ρ = −0.35, P < 0.05). DAP promotes body weight loss in type 2 diabetes mellitus and may decrease fluid retention, thus reducing the occurrence of cardiovascular events.

Favorable effect of sodium–glucose cotransporter 2 inhibitor, dapagliflozin, on non‐alcoholic fatty liver disease compared with pioglitazone

“…The present study was a secondary analysis of our original multicenter, open-label, prospective, randomized, parallel-group comparison trial 9 . All patients provided written informed consent before enrollment.…”

“…All patients provided written informed consent before enrollment. The detailed rationale and protocol of the original trial have been described previously 9 , and are summarized below. Eligible participants included patients with type 2 diabetes mellitus, aged 20-80 years, 6.5-8.5% of glycated hemoglobin (HbA1c), ≥23 kg/m 2 of body mass index (BMI), estimated glomerular filtration rate ≥45 mL/min/1.73 m 2 and treatment with PIO for >12 weeks undergoing outpatient treatment at seven sites in Hokkaido, Japan.…”

“…Sodium-glucose cotransporter 2 (SGLT2) inhibitors have also recently been reported to improve NAFLD [5][6][7][8] ; however, their efficacy in NAFLD has not been proven in large-scale, placebo-controlled studies, and few comparative studies with other antidiabetic drugs have been reported. We recently determined the non-inferiority of dapagliflozin (DAP) for glycemic control, and superiority in terms of weight reduction compared with PIO in patients with type 2 diabetes 9 ; bodyweight was dramatically reduced (-4.2 kg in 24 weeks) by switching from PIO to DAP. In the current study, we aimed to compare the efficacies of DAP and PIO in patients with NAFLD.…”

A randomized controlled trial of two diets enriched with protein or fat in patients with type 2 diabetes treated with dapagliflozin

“…Some studies reported that SGLT2i improved insulin sensitivity, but the degree of improvement varied among type 2 diabetes patients 7 – 10 . However, other reports showed that SGLT2i did not change insulin sensitivity 17 – 19 . In addition, the relation between protein-enriched diet and insulin sensitivity in type 2 diabetes remains obscure.…”

Emerging diagnostic and predictive utilities of natriuretic peptides in diabetes mellitus patients at high cardiovascular risk

“…Recent clinical trials have shown that improving metabolic status in HFrEF patients with pre-diabetes and T2DM with glucagon-like peptide-1 [GLP-1] analogue (liraglutide) [57], sodium-glucose cotransporter-2 [SGLT2] (empagliflozine) [58][59][60], was associated with a tendency to NT-proBNP serum level decrease as a secondary surrogate end point, cardiac protective effect, and beneficial CV outcomes. In contrast, among patients with prediabetes and T2DM without HF serum levels of NT-proBNP remained unaltered regardless of improving glucose homeostasis and decreased CV risk [61]. Interestingly, the change in NT-proBNP serum levels correlated negatively with baseline NT-proBNP levels in T2DM [62].…”