Impact of baseline characteristics and beta‐cell function on the efficacy and safety of subcutaneous once‐weekly semaglutide: A patient‐level, pooled analysis of the SUSTAIN 1‐5 trials

Aim To evaluate the impact of relevant patient‐level characteristics on the efficacy and safety of subcutaneous, once‐weekly semaglutide in subjects with type 2 diabetes. Materials and Methods Exploratory post hoc analyses of pooled SUSTAIN 1‐5 (phase 3a) randomized, controlled trials examined the c...

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Published in:Diabetes, obesity & metabolism obesity & metabolism, 2020-03, Vol.22 (3), p.303-314
Main Authors: Aroda, Vanita R., Capehorn, Matthew S., Chaykin, Louis, Frias, Juan P., Lausvig, Nanna L., Macura, Stanislava, Lüdemann, Jörg, Madsbad, Sten, Rosenstock, Julio, Tabak, Omur, Tadayon, Sayeh, Bain, Stephen C.
Format: Article
Language:English
Subjects:
antidiabetic drug
Antidiabetics
Body weight
Body weight gain
Clinical outcomes
Clinical trials
Diabetes
Diabetes mellitus (non-insulin dependent)
Evidence-based medicine
Glucagon
glucagon‐like peptide‐1
glucagon‐like peptide‐1 analogue
glycaemic control
Hypoglycemia
Obesity
Original
Pancreas
Patients
type 2 diabetes
weight control
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Summary:Aim To evaluate the impact of relevant patient‐level characteristics on the efficacy and safety of subcutaneous, once‐weekly semaglutide in subjects with type 2 diabetes. Materials and Methods Exploratory post hoc analyses of pooled SUSTAIN 1‐5 (phase 3a) randomized, controlled trials examined the change from baseline in HbA1c and body weight (BW), and the proportions of subjects achieving the composite endpoint (HbA1c 7.5%‐8.0%, >8.0%‐8.5%, >8.5%‐9.0% and > 9.0%), background medications, diabetes duration and pancreatic beta‐cell function. Results Mean HbA1c (% point) reductions increased from lowest to highest HbA1c subgroups (−0.9%, −1.2%,‐1.5%, −1.7% and −2.3% [effect of subgroup within treatment: P = 0.247] for semaglutide 0.5 mg, and −1.1%, −1.4%, −1.9%, −2.1% and −2.7% [P = 0.045] for semaglutide 1.0 mg), with mean HbA1c ranges at week 30 of 6.3%‐7.3% and 6.1%‐6.9%, respectively. The corresponding BW reductions generally decreased with increasing baseline HbA1c (−4.4, −3.9, −3.9, −3.3 and −2.9 kg [P = 0.004], and −6.4, −5.9, −5.2, −4.5 and −4.8 kg [P
ISSN:1462-8902
1463-1326
DOI:10.1111/dom.13896