Impact of empagliflozin added on to basal insulin in type 2 diabetes inadequately controlled on basal insulin: a 78‐week randomized, double‐blind, placebo‐controlled trial

Exaggerated anticipatory anxiety is common in social anxiety disorder (SAD). Neuroimaging studies have revealed altered neural activity in response to social stimuli in SAD, but fewer studies have examined neural activity during anticipation of feared social stimuli in SAD. The current study examined the time course and magnitude of activity in threat processing brain regions during speech anticipation in socially anxious individuals and healthy controls (HC). Method Participants (SAD n = 58; HC n = 16) underwent functional magnetic resonance imaging (fMRI) during which they completed a 90s control anticipation task and 90s speech anticipation task.

“…Overall, the effect of tofogliflozin add‐on to insulin therapy was favourable, and mostly consistent with previous long‐term studies on other SGLT2 inhibitors added to insulin . In line with previous studies on long‐term SGLT2 inhibitors added to insulin treatment, a subtle reduction in insulin was observed in this study . The rather small improvement in glucose observed in this study may explain the slight reduction in insulin, as the majority presumably did not require insulin reduction (HbA1c responder rates <7.0% and ≤6.5% at Week 52, 15.0% and 3.6%, respectively, in the tofo‐tofo group).…”

Section: Discussionsupporting

confidence: 90%

Long‐term safety and efficacy of tofogliflozin as add‐on to insulin in patients with type 2 diabetes: Results from a 52‐week, multicentre, randomized, double‐blind, open‐label extension, Phase 4 study in Japan (J‐STEP/INS)

Terauchi

¹

,

Tamura

²

,

Senda

³

et al. 2018

Exaggerated anticipatory anxiety is common in social anxiety disorder (SAD). Neuroimaging studies have revealed altered neural activity in response to social stimuli in SAD, but fewer studies have examined neural activity during anticipation of feared social stimuli in SAD. The current study examined the time course and magnitude of activity in threat processing brain regions during speech anticipation in socially anxious individuals and healthy controls (HC). Method Participants (SAD n = 58; HC n = 16) underwent functional magnetic resonance imaging (fMRI) during which they completed a 90s control anticipation task and 90s speech anticipation task.

“…While some treatment‐by‐subgroup interactions were observed for the change in HbA1c at 16 weeks ( P =0.0195 for baseline HbA1c, P =0.0196 for BMI and P =0.0324 for renal function), the treatment effects of empagliflozin 10 mg or 25 mg versus placebo were generally consistent across subgroups. Both the baseline HbA1c and renal function subgroup interactions are in‐line with previous findings from studies of empagliflozin, which have shown a more pronounced effect in patients with higher baseline HbA1c and those with normal renal function. By contrast, the subgroup interaction observed for BMI was not expected but is probably attributable to the unexpectedly marked effect on HbA1c at 16 weeks observed with placebo in participants in the lowest BMI group (<25 kg/m 2 ).…”

Section: Discussionsupporting

confidence: 89%

“…These results are consistent with the two randomized controlled trials of add-on empagliflozin conducted in Caucasian patients, 18,19 both of which also employed different insulin dosing periods.…”

Section: Discussionsupporting

confidence: 87%

“…During the second period, few insulin adjustments were made suggesting that combining empagliflozin with insulin allowed for long‐term glycaemic control without having to increase insulin doses. These results are consistent with the two randomized controlled trials of add‐on empagliflozin conducted in Caucasian patients, both of which also employed different insulin dosing periods.…”

Section: Discussionsupporting

confidence: 87%

See 1 more Smart Citation

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

Sone

¹

,

Kaneko

²

,

Shiki

³

et al. 2019

Exaggerated anticipatory anxiety is common in social anxiety disorder (SAD). Neuroimaging studies have revealed altered neural activity in response to social stimuli in SAD, but fewer studies have examined neural activity during anticipation of feared social stimuli in SAD. The current study examined the time course and magnitude of activity in threat processing brain regions during speech anticipation in socially anxious individuals and healthy controls (HC). Method Participants (SAD n = 58; HC n = 16) underwent functional magnetic resonance imaging (fMRI) during which they completed a 90s control anticipation task and 90s speech anticipation task.

“…In the present study, the frequency of hypoglycaemia associated with tofogliflozin was higher (~30.0%) than that when tofogliflozin was administered as monotherapy (0% for a 20‐mg dose) . The increased risk of hypoglycaemia when tofogliflozin was administered with insulin is consistent with results for other SGLT2 inhibitors and with results for other SLGT2 inhibitors in Japanese patients . It is important to note that the insulin dose in the present study could only be changed if FPG was ≥240 mg/dL or patients experienced hypoglycaemia.…”

Section: Discussionsupporting

confidence: 87%

Efficacy and safety of tofogliflozin in J apanese patients with type 2 diabetes mellitus with inadequate glycaemic control on insulin therapy ( J‐STEP / INS ): Results of a 16‐week randomized, double‐blind, placebo‐controlled multicentre trial

Terauchi

¹

,

Tamura

²

,

Senda

³

et al. 2017

Exaggerated anticipatory anxiety is common in social anxiety disorder (SAD). Neuroimaging studies have revealed altered neural activity in response to social stimuli in SAD, but fewer studies have examined neural activity during anticipation of feared social stimuli in SAD. The current study examined the time course and magnitude of activity in threat processing brain regions during speech anticipation in socially anxious individuals and healthy controls (HC). Method Participants (SAD n = 58; HC n = 16) underwent functional magnetic resonance imaging (fMRI) during which they completed a 90s control anticipation task and 90s speech anticipation task.