Impact of patient characteristics on efficacy and safety of once-weekly semaglutide versus dulaglutide: SUSTAIN 7 post hoc analyses

Objective In SUSTAIN 7, once-weekly semaglutide demonstrated superior glycated haemoglobin (HbA1c) and body weight (BW) reductions versus once-weekly dulaglutide in subjects with type 2 diabetes (T2D). This post hoc analysis investigated the impact of clinically relevant subject characteristics on treatment effects of semaglutide versus dulaglutide.Design Analyses by baseline age (<65, ≥65 years), sex (male, female), diabetes duration (≤5, >5–10, >10 years), HbA1c (≤7.5, >7.5–8.5, >8.5% (≤58, >58–69, >69 mmol/mol)) and body mass index (BMI) (<30, 30–<35, ≥35 kg/m2).Setting 194 sites; 16 countries.Participants Subjects with T2D (n=1199) exposed to treatment.Interventions Semaglutide 0.5 mg versus dulaglutide 0.75 mg (low-dose comparison); semaglutide 1.0 mg versus dulaglutide 1.5 mg (high-dose comparison), all subcutaneously once weekly.Primary and secondary outcome measures Change in HbA1c (primary endpoint) and BW (confirmatory secondary endpoint) from baseline to week 40; proportion of subjects achieving HbA1c targets (<7%, ≤6.5% (<53, ≤48 mmol/mol)) and weight-loss responses (≥5%, ≥10%) at week 40; and safety.Results HbA1c and BW reductions (estimated treatment difference ranges: –0.22 to –0.70%-point; –1.76 to –3.84 kg) and proportion of subjects achieving HbA1c targets and weight-loss responses were statistically significantly greater for the majority of comparisons of semaglutide versus dulaglutide within each subgroup category and, excepting glycaemic control within the low-dose comparison in HbA1c subgroups, this was irrespective of subgroup or dose comparison. Gastrointestinal adverse events, the most common with both treatments, were reported by more women than men and, with semaglutide, decreased with increasing BMI.Conclusions Consistently greater improvements in HbA1c and BW with semaglutide versus dulaglutide, regardless of age, sex, diabetes duration, glycaemic control and BMI, support the efficacy of semaglutide across the continuum of care in a heterogeneous population with T2D.Trial registration number NCT02648204. Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Ildiko Lingvay [verfasserIn] Emre Yildirim [verfasserIn] Richard E Pratley [verfasserIn] Vanita R Aroda [verfasserIn] Andrei-Mircea Catarig [verfasserIn] Jörg Lüdemann [verfasserIn] Adie Viljoen [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2020

Übergeordnetes Werk:	In: BMJ Open - BMJ Publishing Group, 2011, 10(2020), 11
Übergeordnetes Werk:	volume:10 ; year:2020 ; number:11

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.1136/bmjopen-2020-037883

Katalog-ID:	DOAJ01907025X

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520			\|a Objective In SUSTAIN 7, once-weekly semaglutide demonstrated superior glycated haemoglobin (HbA1c) and body weight (BW) reductions versus once-weekly dulaglutide in subjects with type 2 diabetes (T2D). This post hoc analysis investigated the impact of clinically relevant subject characteristics on treatment effects of semaglutide versus dulaglutide.Design Analyses by baseline age (<65, ≥65 years), sex (male, female), diabetes duration (≤5, >5–10, >10 years), HbA1c (≤7.5, >7.5–8.5, >8.5% (≤58, >58–69, >69 mmol/mol)) and body mass index (BMI) (<30, 30–<35, ≥35 kg/m2).Setting 194 sites; 16 countries.Participants Subjects with T2D (n=1199) exposed to treatment.Interventions Semaglutide 0.5 mg versus dulaglutide 0.75 mg (low-dose comparison); semaglutide 1.0 mg versus dulaglutide 1.5 mg (high-dose comparison), all subcutaneously once weekly.Primary and secondary outcome measures Change in HbA1c (primary endpoint) and BW (confirmatory secondary endpoint) from baseline to week 40; proportion of subjects achieving HbA1c targets (<7%, ≤6.5% (<53, ≤48 mmol/mol)) and weight-loss responses (≥5%, ≥10%) at week 40; and safety.Results HbA1c and BW reductions (estimated treatment difference ranges: –0.22 to –0.70%-point; –1.76 to –3.84 kg) and proportion of subjects achieving HbA1c targets and weight-loss responses were statistically significantly greater for the majority of comparisons of semaglutide versus dulaglutide within each subgroup category and, excepting glycaemic control within the low-dose comparison in HbA1c subgroups, this was irrespective of subgroup or dose comparison. Gastrointestinal adverse events, the most common with both treatments, were reported by more women than men and, with semaglutide, decreased with increasing BMI.Conclusions Consistently greater improvements in HbA1c and BW with semaglutide versus dulaglutide, regardless of age, sex, diabetes duration, glycaemic control and BMI, support the efficacy of semaglutide across the continuum of care in a heterogeneous population with T2D.Trial registration number NCT02648204.
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allfields	10.1136/bmjopen-2020-037883 doi (DE-627)DOAJ01907025X (DE-599)DOAJc6f1b297825643f89d227b421dbb6cff DE-627 ger DE-627 rakwb eng Ildiko Lingvay verfasserin aut Impact of patient characteristics on efficacy and safety of once-weekly semaglutide versus dulaglutide: SUSTAIN 7 post hoc analyses 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objective In SUSTAIN 7, once-weekly semaglutide demonstrated superior glycated haemoglobin (HbA1c) and body weight (BW) reductions versus once-weekly dulaglutide in subjects with type 2 diabetes (T2D). This post hoc analysis investigated the impact of clinically relevant subject characteristics on treatment effects of semaglutide versus dulaglutide.Design Analyses by baseline age (<65, ≥65 years), sex (male, female), diabetes duration (≤5, >5–10, >10 years), HbA1c (≤7.5, >7.5–8.5, >8.5% (≤58, >58–69, >69 mmol/mol)) and body mass index (BMI) (<30, 30–<35, ≥35 kg/m2).Setting 194 sites; 16 countries.Participants Subjects with T2D (n=1199) exposed to treatment.Interventions Semaglutide 0.5 mg versus dulaglutide 0.75 mg (low-dose comparison); semaglutide 1.0 mg versus dulaglutide 1.5 mg (high-dose comparison), all subcutaneously once weekly.Primary and secondary outcome measures Change in HbA1c (primary endpoint) and BW (confirmatory secondary endpoint) from baseline to week 40; proportion of subjects achieving HbA1c targets (<7%, ≤6.5% (<53, ≤48 mmol/mol)) and weight-loss responses (≥5%, ≥10%) at week 40; and safety.Results HbA1c and BW reductions (estimated treatment difference ranges: –0.22 to –0.70%-point; –1.76 to –3.84 kg) and proportion of subjects achieving HbA1c targets and weight-loss responses were statistically significantly greater for the majority of comparisons of semaglutide versus dulaglutide within each subgroup category and, excepting glycaemic control within the low-dose comparison in HbA1c subgroups, this was irrespective of subgroup or dose comparison. Gastrointestinal adverse events, the most common with both treatments, were reported by more women than men and, with semaglutide, decreased with increasing BMI.Conclusions Consistently greater improvements in HbA1c and BW with semaglutide versus dulaglutide, regardless of age, sex, diabetes duration, glycaemic control and BMI, support the efficacy of semaglutide across the continuum of care in a heterogeneous population with T2D.Trial registration number NCT02648204. Medicine R Emre Yildirim verfasserin aut Richard E Pratley verfasserin aut Vanita R Aroda verfasserin aut Andrei-Mircea Catarig verfasserin aut Jörg Lüdemann verfasserin aut Adie Viljoen verfasserin aut In BMJ Open BMJ Publishing Group, 2011 10(2020), 11 (DE-627)654747075 (DE-600)2599832-8 20446055 nnns volume:10 year:2020 number:11 https://doi.org/10.1136/bmjopen-2020-037883 kostenfrei https://doaj.org/article/c6f1b297825643f89d227b421dbb6cff kostenfrei https://bmjopen.bmj.com/content/10/11/e037883.full kostenfrei https://doaj.org/toc/2044-6055 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_375 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2020 11
spelling	10.1136/bmjopen-2020-037883 doi (DE-627)DOAJ01907025X (DE-599)DOAJc6f1b297825643f89d227b421dbb6cff DE-627 ger DE-627 rakwb eng Ildiko Lingvay verfasserin aut Impact of patient characteristics on efficacy and safety of once-weekly semaglutide versus dulaglutide: SUSTAIN 7 post hoc analyses 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objective In SUSTAIN 7, once-weekly semaglutide demonstrated superior glycated haemoglobin (HbA1c) and body weight (BW) reductions versus once-weekly dulaglutide in subjects with type 2 diabetes (T2D). This post hoc analysis investigated the impact of clinically relevant subject characteristics on treatment effects of semaglutide versus dulaglutide.Design Analyses by baseline age (<65, ≥65 years), sex (male, female), diabetes duration (≤5, >5–10, >10 years), HbA1c (≤7.5, >7.5–8.5, >8.5% (≤58, >58–69, >69 mmol/mol)) and body mass index (BMI) (<30, 30–<35, ≥35 kg/m2).Setting 194 sites; 16 countries.Participants Subjects with T2D (n=1199) exposed to treatment.Interventions Semaglutide 0.5 mg versus dulaglutide 0.75 mg (low-dose comparison); semaglutide 1.0 mg versus dulaglutide 1.5 mg (high-dose comparison), all subcutaneously once weekly.Primary and secondary outcome measures Change in HbA1c (primary endpoint) and BW (confirmatory secondary endpoint) from baseline to week 40; proportion of subjects achieving HbA1c targets (<7%, ≤6.5% (<53, ≤48 mmol/mol)) and weight-loss responses (≥5%, ≥10%) at week 40; and safety.Results HbA1c and BW reductions (estimated treatment difference ranges: –0.22 to –0.70%-point; –1.76 to –3.84 kg) and proportion of subjects achieving HbA1c targets and weight-loss responses were statistically significantly greater for the majority of comparisons of semaglutide versus dulaglutide within each subgroup category and, excepting glycaemic control within the low-dose comparison in HbA1c subgroups, this was irrespective of subgroup or dose comparison. Gastrointestinal adverse events, the most common with both treatments, were reported by more women than men and, with semaglutide, decreased with increasing BMI.Conclusions Consistently greater improvements in HbA1c and BW with semaglutide versus dulaglutide, regardless of age, sex, diabetes duration, glycaemic control and BMI, support the efficacy of semaglutide across the continuum of care in a heterogeneous population with T2D.Trial registration number NCT02648204. Medicine R Emre Yildirim verfasserin aut Richard E Pratley verfasserin aut Vanita R Aroda verfasserin aut Andrei-Mircea Catarig verfasserin aut Jörg Lüdemann verfasserin aut Adie Viljoen verfasserin aut In BMJ Open BMJ Publishing Group, 2011 10(2020), 11 (DE-627)654747075 (DE-600)2599832-8 20446055 nnns volume:10 year:2020 number:11 https://doi.org/10.1136/bmjopen-2020-037883 kostenfrei https://doaj.org/article/c6f1b297825643f89d227b421dbb6cff kostenfrei https://bmjopen.bmj.com/content/10/11/e037883.full kostenfrei https://doaj.org/toc/2044-6055 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_375 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2020 11
allfields_unstemmed	10.1136/bmjopen-2020-037883 doi (DE-627)DOAJ01907025X (DE-599)DOAJc6f1b297825643f89d227b421dbb6cff DE-627 ger DE-627 rakwb eng Ildiko Lingvay verfasserin aut Impact of patient characteristics on efficacy and safety of once-weekly semaglutide versus dulaglutide: SUSTAIN 7 post hoc analyses 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objective In SUSTAIN 7, once-weekly semaglutide demonstrated superior glycated haemoglobin (HbA1c) and body weight (BW) reductions versus once-weekly dulaglutide in subjects with type 2 diabetes (T2D). This post hoc analysis investigated the impact of clinically relevant subject characteristics on treatment effects of semaglutide versus dulaglutide.Design Analyses by baseline age (<65, ≥65 years), sex (male, female), diabetes duration (≤5, >5–10, >10 years), HbA1c (≤7.5, >7.5–8.5, >8.5% (≤58, >58–69, >69 mmol/mol)) and body mass index (BMI) (<30, 30–<35, ≥35 kg/m2).Setting 194 sites; 16 countries.Participants Subjects with T2D (n=1199) exposed to treatment.Interventions Semaglutide 0.5 mg versus dulaglutide 0.75 mg (low-dose comparison); semaglutide 1.0 mg versus dulaglutide 1.5 mg (high-dose comparison), all subcutaneously once weekly.Primary and secondary outcome measures Change in HbA1c (primary endpoint) and BW (confirmatory secondary endpoint) from baseline to week 40; proportion of subjects achieving HbA1c targets (<7%, ≤6.5% (<53, ≤48 mmol/mol)) and weight-loss responses (≥5%, ≥10%) at week 40; and safety.Results HbA1c and BW reductions (estimated treatment difference ranges: –0.22 to –0.70%-point; –1.76 to –3.84 kg) and proportion of subjects achieving HbA1c targets and weight-loss responses were statistically significantly greater for the majority of comparisons of semaglutide versus dulaglutide within each subgroup category and, excepting glycaemic control within the low-dose comparison in HbA1c subgroups, this was irrespective of subgroup or dose comparison. Gastrointestinal adverse events, the most common with both treatments, were reported by more women than men and, with semaglutide, decreased with increasing BMI.Conclusions Consistently greater improvements in HbA1c and BW with semaglutide versus dulaglutide, regardless of age, sex, diabetes duration, glycaemic control and BMI, support the efficacy of semaglutide across the continuum of care in a heterogeneous population with T2D.Trial registration number NCT02648204. Medicine R Emre Yildirim verfasserin aut Richard E Pratley verfasserin aut Vanita R Aroda verfasserin aut Andrei-Mircea Catarig verfasserin aut Jörg Lüdemann verfasserin aut Adie Viljoen verfasserin aut In BMJ Open BMJ Publishing Group, 2011 10(2020), 11 (DE-627)654747075 (DE-600)2599832-8 20446055 nnns volume:10 year:2020 number:11 https://doi.org/10.1136/bmjopen-2020-037883 kostenfrei https://doaj.org/article/c6f1b297825643f89d227b421dbb6cff kostenfrei https://bmjopen.bmj.com/content/10/11/e037883.full kostenfrei https://doaj.org/toc/2044-6055 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_375 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2020 11
allfieldsGer	10.1136/bmjopen-2020-037883 doi (DE-627)DOAJ01907025X (DE-599)DOAJc6f1b297825643f89d227b421dbb6cff DE-627 ger DE-627 rakwb eng Ildiko Lingvay verfasserin aut Impact of patient characteristics on efficacy and safety of once-weekly semaglutide versus dulaglutide: SUSTAIN 7 post hoc analyses 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objective In SUSTAIN 7, once-weekly semaglutide demonstrated superior glycated haemoglobin (HbA1c) and body weight (BW) reductions versus once-weekly dulaglutide in subjects with type 2 diabetes (T2D). This post hoc analysis investigated the impact of clinically relevant subject characteristics on treatment effects of semaglutide versus dulaglutide.Design Analyses by baseline age (<65, ≥65 years), sex (male, female), diabetes duration (≤5, >5–10, >10 years), HbA1c (≤7.5, >7.5–8.5, >8.5% (≤58, >58–69, >69 mmol/mol)) and body mass index (BMI) (<30, 30–<35, ≥35 kg/m2).Setting 194 sites; 16 countries.Participants Subjects with T2D (n=1199) exposed to treatment.Interventions Semaglutide 0.5 mg versus dulaglutide 0.75 mg (low-dose comparison); semaglutide 1.0 mg versus dulaglutide 1.5 mg (high-dose comparison), all subcutaneously once weekly.Primary and secondary outcome measures Change in HbA1c (primary endpoint) and BW (confirmatory secondary endpoint) from baseline to week 40; proportion of subjects achieving HbA1c targets (<7%, ≤6.5% (<53, ≤48 mmol/mol)) and weight-loss responses (≥5%, ≥10%) at week 40; and safety.Results HbA1c and BW reductions (estimated treatment difference ranges: –0.22 to –0.70%-point; –1.76 to –3.84 kg) and proportion of subjects achieving HbA1c targets and weight-loss responses were statistically significantly greater for the majority of comparisons of semaglutide versus dulaglutide within each subgroup category and, excepting glycaemic control within the low-dose comparison in HbA1c subgroups, this was irrespective of subgroup or dose comparison. Gastrointestinal adverse events, the most common with both treatments, were reported by more women than men and, with semaglutide, decreased with increasing BMI.Conclusions Consistently greater improvements in HbA1c and BW with semaglutide versus dulaglutide, regardless of age, sex, diabetes duration, glycaemic control and BMI, support the efficacy of semaglutide across the continuum of care in a heterogeneous population with T2D.Trial registration number NCT02648204. Medicine R Emre Yildirim verfasserin aut Richard E Pratley verfasserin aut Vanita R Aroda verfasserin aut Andrei-Mircea Catarig verfasserin aut Jörg Lüdemann verfasserin aut Adie Viljoen verfasserin aut In BMJ Open BMJ Publishing Group, 2011 10(2020), 11 (DE-627)654747075 (DE-600)2599832-8 20446055 nnns volume:10 year:2020 number:11 https://doi.org/10.1136/bmjopen-2020-037883 kostenfrei https://doaj.org/article/c6f1b297825643f89d227b421dbb6cff kostenfrei https://bmjopen.bmj.com/content/10/11/e037883.full kostenfrei https://doaj.org/toc/2044-6055 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_375 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2020 11
allfieldsSound	10.1136/bmjopen-2020-037883 doi (DE-627)DOAJ01907025X (DE-599)DOAJc6f1b297825643f89d227b421dbb6cff DE-627 ger DE-627 rakwb eng Ildiko Lingvay verfasserin aut Impact of patient characteristics on efficacy and safety of once-weekly semaglutide versus dulaglutide: SUSTAIN 7 post hoc analyses 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objective In SUSTAIN 7, once-weekly semaglutide demonstrated superior glycated haemoglobin (HbA1c) and body weight (BW) reductions versus once-weekly dulaglutide in subjects with type 2 diabetes (T2D). This post hoc analysis investigated the impact of clinically relevant subject characteristics on treatment effects of semaglutide versus dulaglutide.Design Analyses by baseline age (<65, ≥65 years), sex (male, female), diabetes duration (≤5, >5–10, >10 years), HbA1c (≤7.5, >7.5–8.5, >8.5% (≤58, >58–69, >69 mmol/mol)) and body mass index (BMI) (<30, 30–<35, ≥35 kg/m2).Setting 194 sites; 16 countries.Participants Subjects with T2D (n=1199) exposed to treatment.Interventions Semaglutide 0.5 mg versus dulaglutide 0.75 mg (low-dose comparison); semaglutide 1.0 mg versus dulaglutide 1.5 mg (high-dose comparison), all subcutaneously once weekly.Primary and secondary outcome measures Change in HbA1c (primary endpoint) and BW (confirmatory secondary endpoint) from baseline to week 40; proportion of subjects achieving HbA1c targets (<7%, ≤6.5% (<53, ≤48 mmol/mol)) and weight-loss responses (≥5%, ≥10%) at week 40; and safety.Results HbA1c and BW reductions (estimated treatment difference ranges: –0.22 to –0.70%-point; –1.76 to –3.84 kg) and proportion of subjects achieving HbA1c targets and weight-loss responses were statistically significantly greater for the majority of comparisons of semaglutide versus dulaglutide within each subgroup category and, excepting glycaemic control within the low-dose comparison in HbA1c subgroups, this was irrespective of subgroup or dose comparison. Gastrointestinal adverse events, the most common with both treatments, were reported by more women than men and, with semaglutide, decreased with increasing BMI.Conclusions Consistently greater improvements in HbA1c and BW with semaglutide versus dulaglutide, regardless of age, sex, diabetes duration, glycaemic control and BMI, support the efficacy of semaglutide across the continuum of care in a heterogeneous population with T2D.Trial registration number NCT02648204. Medicine R Emre Yildirim verfasserin aut Richard E Pratley verfasserin aut Vanita R Aroda verfasserin aut Andrei-Mircea Catarig verfasserin aut Jörg Lüdemann verfasserin aut Adie Viljoen verfasserin aut In BMJ Open BMJ Publishing Group, 2011 10(2020), 11 (DE-627)654747075 (DE-600)2599832-8 20446055 nnns volume:10 year:2020 number:11 https://doi.org/10.1136/bmjopen-2020-037883 kostenfrei https://doaj.org/article/c6f1b297825643f89d227b421dbb6cff kostenfrei https://bmjopen.bmj.com/content/10/11/e037883.full kostenfrei https://doaj.org/toc/2044-6055 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_375 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2020 11
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authorswithroles_txt_mv	Ildiko Lingvay @@aut@@ Emre Yildirim @@aut@@ Richard E Pratley @@aut@@ Vanita R Aroda @@aut@@ Andrei-Mircea Catarig @@aut@@ Jörg Lüdemann @@aut@@ Adie Viljoen @@aut@@
publishDateDaySort_date	2020-01-01T00:00:00Z
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This post hoc analysis investigated the impact of clinically relevant subject characteristics on treatment effects of semaglutide versus dulaglutide.Design Analyses by baseline age (&lt;65, ≥65 years), sex (male, female), diabetes duration (≤5, &gt;5–10, &gt;10 years), HbA1c (≤7.5, &gt;7.5–8.5, &gt;8.5% (≤58, &gt;58–69, &gt;69 mmol/mol)) and body mass index (BMI) (&lt;30, 30–&lt;35, ≥35 kg/m2).Setting 194 sites; 16 countries.Participants Subjects with T2D (n=1199) exposed to treatment.Interventions Semaglutide 0.5 mg versus dulaglutide 0.75 mg (low-dose comparison); semaglutide 1.0 mg versus dulaglutide 1.5 mg (high-dose comparison), all subcutaneously once weekly.Primary and secondary outcome measures Change in HbA1c (primary endpoint) and BW (confirmatory secondary endpoint) from baseline to week 40; proportion of subjects achieving HbA1c targets (&lt;7%, ≤6.5% (&lt;53, ≤48 mmol/mol)) and weight-loss responses (≥5%, ≥10%) at week 40; and safety.Results HbA1c and BW reductions (estimated treatment difference ranges: –0.22 to –0.70%-point; –1.76 to –3.84 kg) and proportion of subjects achieving HbA1c targets and weight-loss responses were statistically significantly greater for the majority of comparisons of semaglutide versus dulaglutide within each subgroup category and, excepting glycaemic control within the low-dose comparison in HbA1c subgroups, this was irrespective of subgroup or dose comparison. 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author	Ildiko Lingvay
spellingShingle	Ildiko Lingvay misc Medicine misc R Impact of patient characteristics on efficacy and safety of once-weekly semaglutide versus dulaglutide: SUSTAIN 7 post hoc analyses
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topic_title	Impact of patient characteristics on efficacy and safety of once-weekly semaglutide versus dulaglutide: SUSTAIN 7 post hoc analyses
topic	misc Medicine misc R
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title	Impact of patient characteristics on efficacy and safety of once-weekly semaglutide versus dulaglutide: SUSTAIN 7 post hoc analyses
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title_full	Impact of patient characteristics on efficacy and safety of once-weekly semaglutide versus dulaglutide: SUSTAIN 7 post hoc analyses
author_sort	Ildiko Lingvay
journal	BMJ Open
journalStr	BMJ Open
lang_code	eng
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author_browse	Ildiko Lingvay Emre Yildirim Richard E Pratley Vanita R Aroda Andrei-Mircea Catarig Jörg Lüdemann Adie Viljoen
container_volume	10
format_se	Elektronische Aufsätze
author-letter	Ildiko Lingvay
doi_str_mv	10.1136/bmjopen-2020-037883
author2-role	verfasserin
title_sort	impact of patient characteristics on efficacy and safety of once-weekly semaglutide versus dulaglutide: sustain 7 post hoc analyses
title_auth	Impact of patient characteristics on efficacy and safety of once-weekly semaglutide versus dulaglutide: SUSTAIN 7 post hoc analyses
abstract	Objective In SUSTAIN 7, once-weekly semaglutide demonstrated superior glycated haemoglobin (HbA1c) and body weight (BW) reductions versus once-weekly dulaglutide in subjects with type 2 diabetes (T2D). This post hoc analysis investigated the impact of clinically relevant subject characteristics on treatment effects of semaglutide versus dulaglutide.Design Analyses by baseline age (<65, ≥65 years), sex (male, female), diabetes duration (≤5, >5–10, >10 years), HbA1c (≤7.5, >7.5–8.5, >8.5% (≤58, >58–69, >69 mmol/mol)) and body mass index (BMI) (<30, 30–<35, ≥35 kg/m2).Setting 194 sites; 16 countries.Participants Subjects with T2D (n=1199) exposed to treatment.Interventions Semaglutide 0.5 mg versus dulaglutide 0.75 mg (low-dose comparison); semaglutide 1.0 mg versus dulaglutide 1.5 mg (high-dose comparison), all subcutaneously once weekly.Primary and secondary outcome measures Change in HbA1c (primary endpoint) and BW (confirmatory secondary endpoint) from baseline to week 40; proportion of subjects achieving HbA1c targets (<7%, ≤6.5% (<53, ≤48 mmol/mol)) and weight-loss responses (≥5%, ≥10%) at week 40; and safety.Results HbA1c and BW reductions (estimated treatment difference ranges: –0.22 to –0.70%-point; –1.76 to –3.84 kg) and proportion of subjects achieving HbA1c targets and weight-loss responses were statistically significantly greater for the majority of comparisons of semaglutide versus dulaglutide within each subgroup category and, excepting glycaemic control within the low-dose comparison in HbA1c subgroups, this was irrespective of subgroup or dose comparison. Gastrointestinal adverse events, the most common with both treatments, were reported by more women than men and, with semaglutide, decreased with increasing BMI.Conclusions Consistently greater improvements in HbA1c and BW with semaglutide versus dulaglutide, regardless of age, sex, diabetes duration, glycaemic control and BMI, support the efficacy of semaglutide across the continuum of care in a heterogeneous population with T2D.Trial registration number NCT02648204.
abstractGer	Objective In SUSTAIN 7, once-weekly semaglutide demonstrated superior glycated haemoglobin (HbA1c) and body weight (BW) reductions versus once-weekly dulaglutide in subjects with type 2 diabetes (T2D). This post hoc analysis investigated the impact of clinically relevant subject characteristics on treatment effects of semaglutide versus dulaglutide.Design Analyses by baseline age (<65, ≥65 years), sex (male, female), diabetes duration (≤5, >5–10, >10 years), HbA1c (≤7.5, >7.5–8.5, >8.5% (≤58, >58–69, >69 mmol/mol)) and body mass index (BMI) (<30, 30–<35, ≥35 kg/m2).Setting 194 sites; 16 countries.Participants Subjects with T2D (n=1199) exposed to treatment.Interventions Semaglutide 0.5 mg versus dulaglutide 0.75 mg (low-dose comparison); semaglutide 1.0 mg versus dulaglutide 1.5 mg (high-dose comparison), all subcutaneously once weekly.Primary and secondary outcome measures Change in HbA1c (primary endpoint) and BW (confirmatory secondary endpoint) from baseline to week 40; proportion of subjects achieving HbA1c targets (<7%, ≤6.5% (<53, ≤48 mmol/mol)) and weight-loss responses (≥5%, ≥10%) at week 40; and safety.Results HbA1c and BW reductions (estimated treatment difference ranges: –0.22 to –0.70%-point; –1.76 to –3.84 kg) and proportion of subjects achieving HbA1c targets and weight-loss responses were statistically significantly greater for the majority of comparisons of semaglutide versus dulaglutide within each subgroup category and, excepting glycaemic control within the low-dose comparison in HbA1c subgroups, this was irrespective of subgroup or dose comparison. Gastrointestinal adverse events, the most common with both treatments, were reported by more women than men and, with semaglutide, decreased with increasing BMI.Conclusions Consistently greater improvements in HbA1c and BW with semaglutide versus dulaglutide, regardless of age, sex, diabetes duration, glycaemic control and BMI, support the efficacy of semaglutide across the continuum of care in a heterogeneous population with T2D.Trial registration number NCT02648204.
abstract_unstemmed	Objective In SUSTAIN 7, once-weekly semaglutide demonstrated superior glycated haemoglobin (HbA1c) and body weight (BW) reductions versus once-weekly dulaglutide in subjects with type 2 diabetes (T2D). This post hoc analysis investigated the impact of clinically relevant subject characteristics on treatment effects of semaglutide versus dulaglutide.Design Analyses by baseline age (<65, ≥65 years), sex (male, female), diabetes duration (≤5, >5–10, >10 years), HbA1c (≤7.5, >7.5–8.5, >8.5% (≤58, >58–69, >69 mmol/mol)) and body mass index (BMI) (<30, 30–<35, ≥35 kg/m2).Setting 194 sites; 16 countries.Participants Subjects with T2D (n=1199) exposed to treatment.Interventions Semaglutide 0.5 mg versus dulaglutide 0.75 mg (low-dose comparison); semaglutide 1.0 mg versus dulaglutide 1.5 mg (high-dose comparison), all subcutaneously once weekly.Primary and secondary outcome measures Change in HbA1c (primary endpoint) and BW (confirmatory secondary endpoint) from baseline to week 40; proportion of subjects achieving HbA1c targets (<7%, ≤6.5% (<53, ≤48 mmol/mol)) and weight-loss responses (≥5%, ≥10%) at week 40; and safety.Results HbA1c and BW reductions (estimated treatment difference ranges: –0.22 to –0.70%-point; –1.76 to –3.84 kg) and proportion of subjects achieving HbA1c targets and weight-loss responses were statistically significantly greater for the majority of comparisons of semaglutide versus dulaglutide within each subgroup category and, excepting glycaemic control within the low-dose comparison in HbA1c subgroups, this was irrespective of subgroup or dose comparison. Gastrointestinal adverse events, the most common with both treatments, were reported by more women than men and, with semaglutide, decreased with increasing BMI.Conclusions Consistently greater improvements in HbA1c and BW with semaglutide versus dulaglutide, regardless of age, sex, diabetes duration, glycaemic control and BMI, support the efficacy of semaglutide across the continuum of care in a heterogeneous population with T2D.Trial registration number NCT02648204.
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title_short	Impact of patient characteristics on efficacy and safety of once-weekly semaglutide versus dulaglutide: SUSTAIN 7 post hoc analyses
url	https://doi.org/10.1136/bmjopen-2020-037883 https://doaj.org/article/c6f1b297825643f89d227b421dbb6cff https://bmjopen.bmj.com/content/10/11/e037883.full https://doaj.org/toc/2044-6055
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author2	Emre Yildirim Richard E Pratley Vanita R Aroda Andrei-Mircea Catarig Jörg Lüdemann Adie Viljoen
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up_date	2024-07-03T21:37:09.655Z
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