Exploring the Potential of the SGLT2 Inhibitor Dapagliflozin in Type 1 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Pilot Study

Henry, Robert R.; Rosenstock, Julio; Edelman, Steven V.; Mudaliar, Sunder; Chalamandaris, Alexandros-Georgios; Kasichayanula, Sreeneeranj; Bogle, Allyson; Iqbal, Nayyar; List, James F.; Griffen, Steven C.

doi:10.2337/dc13-2955

Diabetes Care

2014

DOI: 10.2337/dc13-2955

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Exploring the Potential of the SGLT2 Inhibitor Dapagliflozin in Type 1 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Pilot Study

Robert R. Henry

¹

,

Julio Rosenstock

²

,

Steven V. Edelman

³

et al.

Abstract: OBJECTIVEInsulin adjustments to maintain glycemic control in individuals with type 1 diabetes often lead to wide glucose fluctuations, hypoglycemia, and increased body weight. Dapagliflozin, an insulin-independent sodium-glucose cotransporter 2 (SGLT2) inhibitor, increases glucosuria and reduces hyperglycemia in individuals with type 2 diabetes. The primary objective of this study was to assess short-term safety of dapagliflozin in combination with insulin; secondary objectives included pharmacokinetic, pharma… Show more

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Cited by 228 publications

(251 citation statements)

References 11 publications

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“…Observed and calculated data from the pilot study of dapagliflozin in T1DM at baseline and on day 7 are shown in Table . There was generally a reasonable agreement between the observed mean change from baseline in TDD on day 7 (16.0%, 11.1%, 19.3% and 16.2%) and the virtual “INS:24‐hour‐DAPA equivalent” percent of TDD (10.7%, 13.4%, 18.4% and 22.0%) data for dapagliflozin 1, 2.5, 5 and 10 mg, respectively.…”

Section: Resultssupporting

confidence: 91%

Dapagliflozin in patients with type 1 diabetes: A post hoc analysis of the effect of insulin dose adjustments on 24‐hour continuously monitored mean glucose and fasting β‐hydroxybutyrate levels in a phase IIa pilot study

Henry

¹

,

Dandona

²

,

Pettus

³

et al. 2017

Diabetes Obesity Metabolism

Self Cite

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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.

show abstract

“…Observed and calculated data from the pilot study of dapagliflozin in T1DM at baseline and on day 7 are shown in Table . There was generally a reasonable agreement between the observed mean change from baseline in TDD on day 7 (16.0%, 11.1%, 19.3% and 16.2%) and the virtual “INS:24‐hour‐DAPA equivalent” percent of TDD (10.7%, 13.4%, 18.4% and 22.0%) data for dapagliflozin 1, 2.5, 5 and 10 mg, respectively.…”

Section: Resultssupporting

confidence: 91%

Dapagliflozin in patients with type 1 diabetes: A post hoc analysis of the effect of insulin dose adjustments on 24‐hour continuously monitored mean glucose and fasting β‐hydroxybutyrate levels in a phase IIa pilot study

Henry

¹

,

Dandona

²

,

Pettus

³

et al. 2017

Diabetes Obesity Metabolism

Self Cite

Get access via publisher Add to dashboard 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.

show abstract

“…A recent study evaluating the effect of a 4 weeks dapagliflozin treatment showed improvements in glucose variability when dapagliflozin was added to metformin monotherapy, but not when added to insulin therapy [ 24 ]. Our results are consistent with some of the previous studies [ 15 24 ] showing that the extent to which dapagliflozin decreases glucose variability is insignificant compared with the placebo, although changes compared with the baseline values are observed in patients when this treatment is added to insulin treatment.…”

Section: Discussionsupporting

confidence: 93%

Effect of Dapagliflozin as an Add-on Therapy to Insulin on the Glycemic Variability in Subjects with Type 2 Diabetes Mellitus (DIVE): A Multicenter, Placebo-Controlled, Double-Blind, Randomized Study

Lee

¹

,

Min

²

,

Lee

³

et al. 2021

Get access via publisher Add to dashboard 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.

show abstract

“…UGE increased over 24 h in a dose‐dependent manner with dapagliflozin doses up to 10 mg/day in patients with T1DM (maximum dose administered in this group), and this finding was in accordance with dose‐dependent increases in UGE observed in patients with T2DM (Table ).…”

Section: Resultssupporting

confidence: 87%

Comparison of the pharmacokinetics and pharmacodynamics of dapagliflozin in patients with type 1 versus type 2 diabetes mellitus

Tang

¹

,

Leil

²

,

Johnsson

³

et al. 2016

Diabetes Obesity Metabolism

Get access via publisher Add to dashboard 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.

show abstract

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