Phase III, efficacy and safety study of ertugliflozin monotherapy in people with type 2 diabetes mellitus inadequately controlled with diet and exercise alone

Self Cite

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.

“…The effects of ertugliflozin on body weight observed in this study are consistent with those observed in other Phase 3 studies of ertugliflozin and other SGLT2 inhibitors . In the present study, meaningful differences in the glycaemic efficacy of ertugliflozin 5 or 15 mg, alone or in combination with sitagliptin, were not observed.…”

Section: Discussionsupporting

confidence: 92%

Ertugliflozin plus sitagliptin versus either individual agent over 52 weeks in patients with type 2 diabetes mellitus inadequately controlled with metformin: The VERTIS FACTORIAL randomized trial

Pratley

¹

,

Eldor

²

,

Raji

³

et al. 2018

Self Cite

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.

“…These results are consistent with previously reported findings from the VERTIS Phase 3 clinical trial programme . The reductions in HbA1c from baseline at Week 26 reported here are reflective of those reported in other studies involving SGLT2 inhibitor addition to metformin and DPP‐4 inhibitor background therapy with similar baseline HbA1c values .…”

Section: Discussionsupporting

confidence: 91%

Efficacy and safety of the addition of ertugliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin and sitagliptin: The VERTIS SITA2 placebo‐controlled randomized study

Dagogo‐Jack

¹

,

Liu

²

,

Eldor

³

et al. 2017

Self Cite

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.

“…This magnitude of reduction was similar to that observed with other SGLT2 inhibitors in predominantly Asian or non-Asian patients with T2DM. [15][16][17][18][19][20] PPG were significantly reduced with both janagliflozin doses, results which were consistent with observations that SGLT2 inhibitors affect both fasting glucose and PPG levels. 18,19 The management of body weight plays an important role in T2DM, contributing to the reduction in insulin resistance and the improvement of glycaemic control.…”

Section: Discussionsupporting

confidence: 90%

“…[15][16][17][18][19][20] PPG were significantly reduced with both janagliflozin doses, results which were consistent with observations that SGLT2 inhibitors affect both fasting glucose and PPG levels. 18,19 The management of body weight plays an important role in T2DM, contributing to the reduction in insulin resistance and the improvement of glycaemic control. 21 In this study, janagliflozin 25 mg and janagliflozin 50 mg significantly reduced body weight (placebo-adjusted LS mean changes: À1.27 kg and À1.63 kg, respectively) throughout the 24-week period.…”

Section: Discussionsupporting

confidence: 90%

“…Meanwhile, a large proportion of patients achieved HbA1c <7.0% (53 mmol/mol) and <6.5% (48 mmol/mol) with both janagliflozin doses, and no patients required rescue therapy. Both FPG and 2‐hour PPG were significantly reduced with both janagliflozin doses, results which were consistent with observations that SGLT2 inhibitors affect both fasting glucose and PPG levels 18,19 …”

Section: Discussionsupporting

confidence: 89%

See 1 more Smart Citation

Efficacy and safety of janagliflozin monotherapy in Chinese patients with type 2 diabetes mellitus inadequately controlled on diet and exercise: A multicentre, randomized, double‐blind, placebo‐controlled, Phase 3 trial

Ji

¹

,

Jiang

²

,

Hao

³

et al. 2023

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.