Oral Semaglutide in Real-world Study Found Highly Effective for Uncontrolled HbA1c

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Oral semaglutide prescribed in real-world clinical practice is an effective antihyperglycemic for patients with type 2 diabetes, (T2D) and particularly among those with poorly controlled HbA1c, according to findings presented at the 82nd Scientific Sessions of the American Diabetes Association.

Oral semaglutide was approved by the US Food and Drug Administration in September 2019 for treatment of adults with T2D as the first oral glucagon-like peptide-1 receptor agonist based on the PIONEER clinical trial program. The purpose of the current study was to better understand in clinical settings the effects on HbA1c and characteristics of T2D patients initiating oral semaglutide, both stratified by baseline HbA1c ≥9% and <9%.

The study was a retrospective observational analysis using medical and pharmacy claims data from commercial customers and Medicare Advantage Part D enrollees between November 2018 and December 2020. Inclusion criteria comprised age ≥18 years, ≥1 claims for oral semaglutide (first claim = index date) between November 2019 and June 2020, ≥1 T2D diagnosis during the pre-index period, and continuous enrollment for 12 months before and including index (baseline) and 6 months post-index (follow-up). Pregnancy was an exclusion criterion.

Findings for change in HbA1c and patient characteristics were divided by participants’ last baseline HbA1c, <9% or ≥9%.

Findings

Investigators identified 3466 patients with ≥1 claim for oral semaglutide and of those, 994 had ≥1 HbA1c value during baseline. Among this population, 267 participants had HbA1c ≥9% and 727<9%.

When they looked at participant characteristics, the researchers noted that patients with baseline HbA1c <9% were slightly older (59.6 years) than patients with HbA1c ≥9% (57.6 years) (P = .018). The group with HbA1c <9% was 50.4% men and 63.1% had commercial coverage. They found no significant differences between the HbA1c groups in the proportion of patients with atherosclerotic cardiovascular disease, heart failure, chronic kidney disease, stroke, depression, or anxiety.

For all participants with baseline and follow-up A1c values (n = 652), the mean change in HbA1c was -0.79%. Among those with baseline HbA1c ≥9%, mean change was -1.99% compared to -0.35% among patients with HbA1c <9% (P <.001).

Within a subset of "persistent" patients (≥90 days of continuous semaglutide treatment and ≥1 HbA1c measure after ≥90 days of treatment; n = 200), the HbA1c ≥9% group had a mean change of -2.7% while the change among those in the A1c <9% group was -0.48% (P <.001).

A further observation was that a higher percentage of persistent patients with baseline HbA1c ≥9% (86.8%) experienced a change in the glucose surrogate level of ≥1% compared to those with baseline at <9% (31.5%; P = .001). When the researchers looked at index prescriptions for semaglutide, they found that 43% of patients were prescribed the recommended 3 mg starting dose.

Of interest, the research team found that half (50.6%) of index treatments were prescribed by primary care and internal medicine clinicians and that a higher percentage of patients with A1c <9% were first prescribed semaglutide by an endocrinologist (24.4% vs 16.1%; P =.006).

The investigators conclude that oral semaglutide is effective for treatment of T2D in real world clinical practice and that it has a particularly beneficial impact on individuals with uncontrolled HbA1c before treatment is initiated. The findings also suggest that persons in this population are more often prescribed oral semaglutide by a primary care clinician than an endocrinologist.

“More research is needed to understand the relationship between provider specialty, A1c values, and prescribing patterns,” they said.

Reference: Frazer MS, Swift C, Leszeko M, et al. Real-world A1c changes and prescribing provider types among T2DM patients initiating treatment with oral semaglutide. Diabetes 2022;71(Supplement_1):127-LB