KMID : 1200020190430040432
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Diabetes & Metabolism Journal 2019 Volume.43 No. 4 p.432 ~ p.446
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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
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Kang Yu-Mi
Jung Chang-Hee Lee Seung-Hwan Kim Sang-Wook Song Kee-Ho Kim Sin-Gon Kim Jae-Hyeon Cho Young-Min Park Tae-Sun Ku Bon-Jeong Koh Gwan-Pyo Kim Dol-Mi Lee Byung-Wan Park Joong-Yeol
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Abstract
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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 ¡Ã7.5%) 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 ¡Â7.0%. 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 ¡Â7.0%. The mean differences in body weight and fasting plasma glucose were 1.2¡¾3.4 kg and 56.0¡¾49.8 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¡¾2.5 kg vs. ?0.9¡¾6.0 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.
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KEYWORD
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Diabetes mellitus, type 2, Insulin glargine, Safety
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