PIONEER REAL UK: A Multi-Centre, Prospective, Real-World Study of Once-Daily Oral Semaglutide Use in Adults with Type 2 Diabetes

📖 Top 20% JournalSep 24, 2024Advances in therapy

Daily Oral Semaglutide Use in Adults with Type 2 Diabetes: A Real-World Study Across Multiple UK Centers

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Abstract

Participants experienced a -1.1%-point reduction in glycated hemoglobin (HbA) after 34-44 weeks of oral semaglutide treatment.

Of 333 enrolled participants, 299 completed the study and 227 were on treatment at the end of the study.
The estimated change in body weight was -4.8 kg.
At the end of the study, 46.3% of participants had an HbA level below 7% (53 mmol/mol).
A reduction of 1%-point in HbA combined with at least a 3% reduction in body weight was observed in 36.4% of participants.
No new safety concerns or severe hypoglycemia cases were reported during the study.

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INTRODUCTION: Oral semaglutide provides an alternative to injectable glucagon-like peptide-1 receptor agonists (GLP-1RAs) for treatment of type 2 diabetes (T2D). The PIONEER REAL studies evaluate clinical outcomes of oral semaglutide treatment of T2D in a real-world setting. PIONEER REAL UK focused on adults living with T2D in the UK.

METHODS: The multi-centre, prospective and non-interventional single-arm study enrolled 333 participants and followed them for 34-44 weeks. Participants were treated as part of routine clinical practice and had not been previously treated with injectable glucose-lowering medication. The primary endpoint was change in glycated haemoglobin (HbA) from baseline to end of study (EOS). Secondary endpoints included change in body weight, proportion of participants with HbA < 7% (53 mmol/mol) at EOS and proportion of participants with ≥ 1%-point HbAreduction and body weight reduction of ≥ 3% or ≥ 5% at EOS. Treatment satisfaction was assessed by Diabetes Treatment Satisfaction Questionnaire (DTSQ) status and change. 1C1C1C

RESULTS: Of 333 participants, 299 completed the study and 227 were on treatment at EOS. People treated with oral semaglutide experienced significantly reduced HbAby an estimated change of - 1.1%-points (95% CI - 1.27 to - 0.96; P < 0.0001) or - 12.2 mmol/mol (CI - 13.87 to - 10.47; P < 0.0001). Estimated change in body weight was - 4.8 kg (CI - 5.47 to - 4.12; P < 0.0001). At EOS, an HbAlevel < 7% (53 mmol/mol) was recorded in 46.3% of participants. A ≥ 1%-point reduction in HbAcombined with a ≥ 3% reduction in body weight was observed in 36.4% of participants, and 27.1% had a ≥ 1%-point reduction in HbAand a ≥ 5% body weight reduction. Treatment satisfaction improved significantly during the study. No new safety concerns or cases of severe hypoglycaemia were reported. 1C1C1C1C

CONCLUSION: People living with T2D in the UK experienced a meaningful decrease in HbAand body weight after initiation of oral semaglutide treatment. No new safety issues were observed. 1C

TRIAL REGISTRATION: ClinicalTrials.gov: NCT04862923. Graphical plain language summary available for this article.

Key numbers

-1.1%

Decrease in HbA

Change in glycated hemoglobin from baseline to

-4.8 kg

Weight loss

Average change in body weight from baseline to

46.3%

Participants achieving HbA < 7%

Percentage of participants with HbA < 7% at

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Abstract

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