What question did this study set out to answer?

To describe the pragmatic study design, PRECIS-2 evaluation, and baseline characteristics of patients enrolled in the 2-year SEPRA pragmatic clinical trial.

May 31, 2022Diabetes

752-P: Study Design and Baseline Profile for Patients with Type 2 Diabetes in the Semaglutide Once-Weekly Randomized Pragmatic Trial (SEPRA)

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To describe the pragmatic study design, PRECIS-2 evaluation, and baseline characteristics of patients enrolled in the 2-year SEPRA pragmatic clinical trial.
Multicenter, open-label, randomized pragmatic clinical trial (NCT03596450) conducted in the US evaluating once-weekly subcutaneous semaglutide versus standard of care added to ≤2 oral antidiabetic medications over a 2-year duration.
Pragmatism was assessed across 9 domains using the Pragmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) tool, with primary follow-up data derived from routine clinical practice and health insurance claims.
Enrolled N=1,278 insured adults with type 2 diabetes and physician-determined inadequate glycemic control, targeting a primary endpoint of HbA1c <7.0% at year 1.
The PRECIS-2 evaluation scored 4 to 5 across all 9 domains, confirming a highly pragmatic study design embedded in routine care.
Enrolled participants (N=1,278; 54% male) had a mean age of 57.4 ± 11.1 years, mean BMI of 35.7 ± 8.0 kg/m², and mean diabetes duration of 7.4 ± 6.0 years.
Baseline mean HbA1c was 8.48 ± 1.6% compared to a clinician-assigned individualized target of 6.66 ± 0.5%, with 86.9% of participants presenting with baseline HbA1c >7.0%.

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Implication

Randomized trial reports baseline profiles for once-weekly semaglutide in type 2 diabetes, highlighting widespread suboptimal glycemic control requiring treatment intensification.

Cite This Study

Willey et al. (2022) studied this question.

synapsesocial.com/papers/6a7039f5a528af2d65c3672b https://doi.org/10.2337/db22-752-p

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Implication

Randomized trial reports baseline profiles for once-weekly semaglutide in type 2 diabetes, highlighting widespread suboptimal glycemic control requiring treatment intensification.

752-P: Study Design and Baseline Profile for Patients with Type 2 Diabetes in the Semaglutide Once-Weekly Randomized Pragmatic Trial (SEPRA)

Key Points

Discussion

Implication

Cite This Study

752-P: Study Design and Baseline Profile for Patients with Type 2 Diabetes in the Semaglutide Once-Weekly Randomized Pragmatic Trial (SEPRA)

Key Points

Discussion

Implication

Cite This Study

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