Banerji, Mary Ann; Baron, Michelle A.; Gao, Ling; Blonde, Lawrence
Abstract
Purpose: Optimizing glycemic control in patients with type 2 diabetes mellitus (T2DM) not controlled with >= 1 oral antidiabetes drugs (OADs) is challenging. Many therapeutic options exist; however, data comparing the effectiveness of different strategies are lacking for the management of patients with T2DM. Our study aim was to provide comparative data on efficacy and hypoglycemia when initiating insulin glargine (glargine) versus alternative treatment options (not including the newest antidiabetes agents, glucagon-like peptide [GLP]-1 receptor agonists, dipeptidyl peptidase [DPP]-4 inhibitors or sodium-glucose linked transporter [SGLT]-2 inhibitors) in insulin-naive patients with T2DM who remained uncontrolled with OADs. Methods: Patient-level data were pooled from 9 randomized controlled trials of >= 24 weeks duration with comparable patient populations. The effect of adding glargine was compared with intensification of lifestyle interventions or OADs, addition of neutral protamine Hagedorn (NPH) insulin, insulin lispro, premixed insulin, or all comparators pooled, on patient glycated hemoglobin (HbA(1c)) level, fasting plasma glucose level, weight, and hypoglycemia. Results: A greater proportion of patients achieved a target HbA(1c) level <= 7.0% with glargine treatment than with pooled comparators, intensification of OADs, or lifestyle interventions; there was no difference when compared with NPH, premixed, or insulin lispro use. The rate for reported hypoglycemic events was lower for glargine use than for pooled comparators or other insulins, but higher compared with intensification of lifestyle interventions or OADs. When stratified by baseline HbA(1c) level, efficacy/target attainment with glargine use was better than for pooled comparators across all HbA(1c) strata; OAD intensification, when baseline HbA(1c) level was >= 8.0%; and premixed insulin if baseline HbA(1c) level was, 8.0%; but similar to other insulins for all other categories. The incidence of reported hypoglycemia was less frequent with glargine use than other insulins, but more frequent than intensification of lifestyle interventions or OADs. Conclusion: When adequate glycemic control is not achieved using OADs in patients with T2DM, initiating insulin glargine is generally less likely to elicit hypoglycemia than initiating NPH, premixed, or prandial insulins, and the benefit-risk balance supports initiating insulin rather than intensification of OAD therapy when baseline HbA(1c) level is >= 8.0%.
