Abstract
We assessed whether comparative efficacy and safety of biphasic insulin aspart 30 (BIAsp 30) plus metformin versus BIAsp 30 monotherapy differed for patients with type 2 diabetes mellitus (T2DM) inadequately controlled with oral antidiabetic drugs with different cardiovascular risk scores and different body mass indexes (BMI) by performing a post hoc analysis of the randomized controlled MERIT study. In the MERIT study, eligible patients were randomized 1:1 to receive BIAsp 30 plus metformin or BIAsp 30 for 16 weeks. Patients in the 2 treatment groups were classified into “low” and “high” risk subgroups based on their GloboRisk scores and into “BMI ≤ 26 kg/m2”and “BMI > 26 kg/m2” subgroups. Primary efficacy endpoint was between-treatments comparison of HbA1c changes from baseline for these 2 sets of subgroups. Between-treatments comparisons of secondary efficacy and safety endpoints were also performed. We found that BIAsp 30 plus metformin led to significantly higher percentage of high-risk patients achieving HbA1c target < 7% than BIAsp 30 monotherapy, with an overall comparable safety profile for high-risk patients. Meanwhile, for patients with BMI ≤ 26 kg/m2, compared with BIAsp 30 monotherapy, BIAsp 30 plus metformin led to significantly higher percentages of patients achieving HbA1c target (47.83% vs 28.17%, P = 0.0165) and composite target of HbA1c < 7% without hypoglycemia or weight gain (20.29% vs 6.85%, P = 0.0187) and have a slightly better safety profile. In conclusion, for T2DM patients at high CV risk or with BMI ≤ 26 kg/m2, BIAsp 30 plus metformin was preferable to BIAsp 30 monotherapy.
Highlights
Type 2 diabetes mellitus (T2DM) is a progressive disease characterized by continuing decline of pancreatic islet β-cell function and subsequent decrease in endogenous insulin s ecretion[1,2,3]
For patients with body mass index (BMI) ≤ 26 kg/ m2, compared with BIAsp 30 monotherapy, BIAsp 30 plus metformin led to significantly higher percentages of patients achieving HbA1c target of < 7% (47.83% vs 28.17%, P = 0.0165) and achieving the composite target of HbA1c < 7% without hypoglycemia or weight gain (20.29% vs 6.85%, P = 0.0187), though not for patients with BMI > 26 kg/m2 (Table 3)
For patients with BMI > 26 kg/m2, compared with BIAsp 30 monotherapy, BIAsp 30 plus metformin led to significantly greater percentage of patients having hypoglycemic episode(s) (26.05% vs 9.52%, P = 0.0442) and significantly more hypoglycemic episode per person (0.46 ± 0.91 vs 0.10 ± 0.30, P = 0.0329), as well as comparable percentages of patients experiencing adverse events (AEs) and treatment-related adverse reactions and comparable weight gain from baseline (All P > 0.05) (Table 4). In this post hoc analysis of the MERIT study, we found that for patients at high 10-year CV risk (GloboRisk score ≥ 20%), compared with BIAsp 30 monotherapy, BIAsp 30 with metformin had a somewhat better efficacy profile and an overall comparable safety profile, while BIAsp 30 with and without metformin had comparable efficacy and safety profiles for patients at low 10-year CV risk
Summary
Type 2 diabetes mellitus (T2DM) is a progressive disease characterized by continuing decline of pancreatic islet β-cell function and subsequent decrease in endogenous insulin s ecretion[1,2,3]. The 16-week randomized, parallel-controlled MERIT study was designed to mimic the real-life practice in China and to assess efficacy and safety of BIAsp 30 with and without metformin for patients with T2DM inadequately controlled with O ADs5. It found that BIAsp[30] plus metformin was not inferior to BIAsp 30 monotherapy in safely reducing HbA1c level, that BIAsp 30 plus metformin was Scientific Reports | (2021) 11:4131. One aim of the current study was to perform a post hoc analysis of the MERIT study to assess whether and how comparative efficacy and safety of BIAsp 30 with and without metformin differed for patients with different 10-year CVD risk score calculated based on laboratory-based GloboRisk. We did a preliminary analysis regarding whether comparative efficacy and safety of BIAsp 30 with and without metformin differed for patients with BMI ≤ 26 kg/m2 versus BMI > 26 kg/m2
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