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- Title
Effectiveness and Safety of Adding Basal Insulin Glargine in Patients with Type 2 Diabetes Mellitus Exhibiting Inadequate Response to Metformin and DPP-4 Inhibitors with or without Sulfonylurea.
- Authors
Yu Mi Kang; Chang Hee Jung; Seung-Hwan Lee; Sang-Wook Kim; Kee-Ho Song; Sin Gon Kim; Jae Hyeon Kim; Young Min Cho; Tae Sun Park; Bon Jeong Ku; Gwanpyo Koh; Dol Mi Kim; Byung-Wan Lee; Joong-Yeol Park
- Abstract
Background: We aimed to investigate the effectiveness and safety of adding basal insulin to initiating dipeptidyl peptidase-4 (DPP-4) inhibitor and metformin and/or sulfonylurea (SU) in achieving the target glycosylated hemoglobin (HbA1c) in patients with type 2 diabetes mellitus (T2DM). Methods: This was a single-arm, multicenter, 24-week, open-label, phase 4 study in patients with inadequately controlled (HbA1c =7.5%) T2DM despite the use of DPP-4 inhibitor and metformin. A total of 108 patients received insulin glargine while continuing oral antidiabetic drugs (OADs). The primary efficacy endpoint was the percentage of subjects achieving HbA1c =7.0%. Other glycemic profiles were also evaluated, and the safety endpoints were adverse events (AEs) and hypoglycemia. Results: The median HbA1c at baseline (8.9%; range, 7.5% to 11.1%) decreased to 7.6% (5.5% to 11.7%) at 24 weeks. Overall, 31.7% subjects (n=33) achieved the target HbA1c level of =7.0%. The mean differences in body weight and fasting plasma glucose were 1.2±3.4 kg and 56.0±49.8 mg/dL, respectively. Hypoglycemia was reported in 36 subjects (33.3%, 112 episodes), all of which were fully recovered. There was no serious AE attributed to insulin glargine. Body weight change was significantly different between SU users and nonusers (1.5±2.5 kg vs. -0.9±6.0 kg, P=0.011). Conclusion: The combination add-on therapy of insulin glargine, on metformin and DPP-4 inhibitors with or without SU was safe and efficient in reducing HbA1c levels and thus, is a preferable option in managing T2DM patients exhibiting dysglycemia despite the use of OADs.
- Subjects
TYPE 2 diabetes; DAPAGLIFLOZIN; INSULIN; GLYCOSYLATED hemoglobin; METFORMIN; HEMOGLOBINS; HYPOGLYCEMIA
- Publication
Diabetes & Metabolism Journal, 2019, Vol 43, Issue 4, p432
- ISSN
2233-6079
- Publication type
Article
- DOI
10.4093/dmj.2018.0092