In US adults with type 2 diabetes needing treatment intensification, once-weekly improved long-term glycemic control more than physician-chosen alternative therapy and produced greater 1-year weight loss.
Evidence
This 2-year randomized open-label pragmatic clinical trial assigned 644 adults to semaglutide and 634 to alternative treatment and found more patients reached HbA1c below 7.0% at years 1 and 2, with larger HbA1c reductions and greater weight loss at year 1.
Caveat
Because the trial was open-label and the comparator was a physician-chosen mix of alternative treatments, the results may reflect pragmatic treatment selection as well as drug effect.
Simplified
INTRODUCTION: This study evaluated the long-term effectiveness of once-weekly subcutaneous versus alternative treatment in adults with type 2 diabetes (T2D) in routine clinical practice.
RESEARCH DESIGN AND METHODS: The SEmaglutide PRAgmatic (SEPRA) was a 2-year, randomized, open-label, pragmatic clinical trial (NCT03596450). Adults with T2D and inadequate glycemic control on one or two oral antidiabetic medications were randomized to receive once-weekly subcutaneous semaglutide or alternative treatment (chosen by the treating physician) as add-on therapy. Endpoints included proportion of participants achieving (HbA)<7.0% at year 1 (primary endpoint) and year 2; changes in HbA(percentage point), body weight, and patient-reported outcomes (PROs) at years 1 and 2; and treatment changes (baseline to year 2). Missing data were imputed for some analyses. 1c1c
RESULTS: Participants were randomized to semaglutide (n=644) or alternative treatment (n=634). Proportions of participants achieving HbA<7.0% were significantly higher with semaglutide versus alternative treatment at years 1 (53.1% vs 45.5%; OR (95% CI): 1.36 (1.03 to 1.79); p=0.033) and 2 (49.9% vs 38.9%; OR (95% CI): 1.56 (1.13 to 2.16); p=0.007). Mean HbAdecreases were larger with semaglutide versus alternative treatment at year 1 (-1.35% vs -1.16%; estimated treatment difference (ETD) (95% CI): -0.20% (-0.39% to 0.00%); p=0.046) and year 2 (-1.27% vs -0.96%; ETD (95% CI): -0.31% (-0.57% to -0.05%); p=0.018). Semaglutide was associated with larger reductions in body weight at year 1 (-3.57% vs -1.91%; ETD (95% CI): -1.65% (-2.92% to -0.39%); p=0.010) but not year 2 (p=0.175). Treatment changes occurred less frequently with semaglutide than with alternative treatments. Some PROs indicated greater improvement with semaglutide versus alternative treatment. No new safety concerns were identified. 1c1c
CONCLUSIONS: SEPRA demonstrates that semaglutide is an appropriate choice for treatment intensification among individuals with T2D in the USA who are receiving 1-2 antidiabetic medications. Findings support semaglutide as an effective and well-tolerated option in clinical practice.
TRIAL REGISTRATION NUMBER: NCT03596450.
Key numbers
53.1%
Increase in <7.0%
At year 1, 53.1% of participants reached <7.0%, vs. 45.5% for alternatives.
-1.35%
Mean reduction
At year 1, mean reduction was -1.35% for vs. -1.16% for alternatives.
-3.57%
Weight loss percentage
At year 1, body weight change was -3.57% for vs. -1.91% for alternatives.
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