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Observational Study
. 2023 Mar;40(3):920-933.
doi: 10.1007/s12325-022-02385-x. Epub 2022 Dec 21.

Once-Weekly Semaglutide Use in Type 2 Diabetes: Real-World Data from the SURE Netherlands Observational Study

Affiliations
Observational Study

Once-Weekly Semaglutide Use in Type 2 Diabetes: Real-World Data from the SURE Netherlands Observational Study

Bruce H R Wolffenbuttel et al. Adv Ther. 2023 Mar.

Abstract

Introduction: SURE Netherlands (NCT03929679) evaluated the use of once-weekly (OW) semaglutide, a glucagon-like peptide 1 receptor agonist (GLP-1RA), in routine clinical care for individuals with type 2 diabetes (T2D).

Methods: Adults (age ≥ 18 years) with T2D were enrolled into the single-arm study. The primary endpoint was change from baseline to end of study (EOS; approx. 30 weeks) in glycated haemoglobin (HbA1c). Secondary endpoints were change from baseline to EOS in body weight (BW) and waist circumference (WC). Proportions of participants achieving predefined HbA1c targets and weight-loss responses at EOS, safety, health-related quality of life (HRQoL) and treatment satisfaction were assessed.

Results: In total, 211 participants (mean age 60.5 years; diabetes duration 13.3 years) initiated semaglutide; most were receiving metformin (82.9%) and/or basal insulin (59.2%) at baseline, and 6.2% switched from another GLP-1RA. Mean baseline HbA1c, BW and WC were 8.6%, 105.2 kg and 118.8 cm. In the 186 (88.2%) participants receiving semaglutide at EOS, mean reduction in HbA1c with semaglutide was - 1.2%-points (95% [confidence interval] CI - 1.3; - 1.0; p < 0.0001), with 124 (70.5%), 95 (54.0%) and 65 (36.9%) participants achieving HbA1c targets of < 8.0%, < 7.5% and < 7.0%, respectively. Mean reduction in BW was - 7.8 kg [95% CI - 8.7; - 6.8; p < 0.0001], corresponding to relative reduction of - 7.5% [95% CI - 8.4; - 6.6; p < 0.0001]. Improvements in WC (- 8.8 cm [95% CI - 10.4; - 7.2; p < 0.0001]), HRQoL and treatment satisfaction were observed, including across most Short-Form 36 Health Survey domains. One serious adverse drug reaction (cholecystitis) was reported. Eight participants (all receiving concomitant insulin) experienced severe or documented hypoglycaemia.

Conclusion: Individuals with T2D treated with OW semaglutide experienced significant and clinically relevant improvements in glycaemic control and BW from baseline. These results from a diverse real-world population in the Netherlands support the use of OW semaglutide in treating adults with T2D in routine clinical practice.

Keywords: Body weight; Glucagon-like peptide 1 receptor agonist; Glycated haemoglobin; Health-related quality of life; Observational study; Real-world evidence; SURE; Semaglutide; Type 2 diabetes.

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Figures

Fig. 1
Fig. 1
Proportions of participants at EOS achieving a HbA1c targets of < 8.0%, < 7.5%, < 7.0% and ≥ 1.0%-point reduction; b weight-loss responses of ≥ 3 and ≥ 5%. Data are from the EAS. BW, body weight; EAS, effectiveness analysis set; EOS, end of study; n, number of participants
Fig. 2
Fig. 2
Absolute changes in SF–36®v2 subdomain scores from baseline to EOS. *p < 0.0001; p < 0.005. A higher SF-36®v2 score indicates greater functionality. Data are from the EAS. EOS, end of study; ns, not significant; SF-36®v2, 36-Item Short-Form Health Survey version 2

References

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