Diabetes Care
 2014
DOI: 10.2337/dc14-1142
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Dual Add-on Therapy in Type 2 Diabetes Poorly Controlled With Metformin Monotherapy: A Randomized Double-Blind Trial of Saxagliptin Plus Dapagliflozin Addition Versus Single Addition of Saxagliptin or Dapagliflozin to Metformin

Julio Rosenstock
1
,
Lars Hansen
2
,
Pamela Zee
3
et al.

Abstract: OBJECTIVEThis study compared the efficacy and safety of dual add-on of saxagliptin plus dapagliflozin versus saxagliptin and dapagliflozin added on alone in patients with type 2 diabetes poorly controlled with metformin. RESEARCH DESIGN AND METHODSThis was a double-blind trial in adults with HbA 1c ‡8.0% and £12.0% (64-108 mmol/mol), randomized to saxagliptin (SAXA) (5 mg/day) plus dapagliflozin (DAPA) (10 mg/day; n = 179), or SAXA (5 mg/day) and placebo (n = 176), or DAPA (10 mg/day) and placebo (n = 179) on … Show more

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Cited by 277 publications

(347 citation statements)
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“…The decline in HbA 1c with DAPA/SAXA was significantly greater than with DAPA alone (22.0 vs. 21.4%, P , 0.001), and this primarily was accounted for by the greater decline in FPG concentration (77 vs. 47 mg/ dL, P , 0.001). These differences could not be accounted for by differences in weight loss or body fat distribution (Table 1) and are in agreement with previously reported findings (20,25). Consistent with results published earlier from our laboratory (13)(14)(15)19) (26).…”
Section: Discussionsupporting
confidence: 93%
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.
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“…The decline in HbA 1c with DAPA/SAXA was significantly greater than with DAPA alone (22.0 vs. 21.4%, P , 0.001), and this primarily was accounted for by the greater decline in FPG concentration (77 vs. 47 mg/ dL, P , 0.001). These differences could not be accounted for by differences in weight loss or body fat distribution (Table 1) and are in agreement with previously reported findings (20,25). Consistent with results published earlier from our laboratory (13)(14)(15)19) (26).…”
Section: Discussionsupporting
confidence: 93%
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
“…All treatment regimens were well tolerated, and the safety profile of the dapagliflozin‐saxagliptin combination was in line with that of the individual drugs, without additional side effects. Findings from this study are in accordance with those from previous studies of dapagliflozin and saxagliptin when administered as part of either dual or triple therapy with metformin . The results were also in line with previous head‐to‐head comparisons of dapagliflozin and other SGLT‐2 inhibitors vs sulphonylureas …”
Section: Discussionsupporting
confidence: 91%
“…Dapagliflozin‐containing treatment regimens were well tolerated during the study. Although there were more UTIs and genital infections in the dapagliflozin groups than in the glimepiride group, these were all mild or moderate in intensity and the frequency was consistent with previous reports . In line with some previous reports, the frequency of both types of infection was lower in the dapagliflozin plus saxagliptin combination arm compared with the dapagliflozin arm.…”
Section: Discussionsupporting
confidence: 91%
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
“…Our study showed a reduction in the mean body weight (74.2 ± 12.6 kg versus 72.2 ± 11.5 kg) with the mean change from baseline of 2.1 kg following 24 weeks of treatment (p < 0.0001). These results corroborate prior findings with the mean change in body weight from baseline ranging from -1.5 to -2.1 kg at 24 weeks ( 9 , 10 , 12 , 27 , 29 ) and -2.3 to -3.2 kg at 52 weeks ( 10 , 27 , 28 ), with the combination of dapagliflozin and saxagliptin. These findings highlighted that effective glycemic control is achieved with the use of a combination of dapagliflozin and saxagliptin without a corresponding increase in body weight.…”
Section: Discussionsupporting
confidence: 91%
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.
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