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.
['Pratley|Richard E|RE|0000-0002-2912-1389', 'Aroda|Vanita R|VR|0000-0002-7706-4585', 'Catarig|Andrei-Mircea|AM|', 'Lingvay|Ildiko|I|', 'Lüdemann|Jörg|J|', 'Yildirim|Emre|E|', 'Viljoen|Adie|A|']
D000368:Aged D003924:Diabetes Mellitus, Type 2 D005260:Female D004763:Glucagon-Like Peptides D006442:Glycated Hemoglobin A D006801:Humans D007004:Hypoglycemic Agents D007141:Immunoglobulin Fc Fragments D008297:Male D011993:Recombinant Fusion Proteins
clinical trials diabetes & endocrinology general diabetes