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

被引：2

作者：

Kang, Yu Mi ^{[1
]}

Jung, Chang Hee ^{[1
]}

Lee, Seung-Hwan ^{[2
]}

Kim, Sang-Wook ^{[3
]}

Song, Kee-Ho ^{[4
]}

Kim, Sin Gon ^{[5
]}

Kim, Jae Hyeon ^{[6
]}

Cho, Young Min ^{[7
]}

Park, Tae Sun ^{[8
]}

Ku, Bon Jeong ^{[9
]}

Koh, Gwanpyo ^{[10
]}

Kim, Dol Mi ^{[11
]}

Lee, Byung-Wan ^{[12
]}

Park, Joong-Yeol ^{[1
]}

机构：

[1] Univ Ulsan, Asan Med Ctr, Dept Internal Med, Coll Med, 88 Olymp Ro 43 Gil, Seoul 05505, South Korea

[2] Catholic Univ Korea, Seoul St Marys Hosp, Coll Med, Dept Internal Med,Div Endocrinol & Metab, Seoul, South Korea

[3] Kangwon Natl Univ, Dept Internal Med, Sch Med, Chunchon, South Korea

[4] Konkuk Univ, Sch Med, Dept Internal Med, Med Ctr, Seoul, South Korea

[5] Korea Univ, Dept Internal Med, Div Endocrinol & Metab, Coll Med, Seoul, South Korea

[6] Sungkyunkwan Univ, Thyroid Ctr, Samsung Med Ctr, Dept Med,Sch Med,DiAs Endocrinol & Metab, Seoul, South Korea

[7] Seoul Natl Univ, Seoul Natl Univ Hosp, Dept Internal Med, Coll Med, Seoul, South Korea

[8] Chonbuk Natl Univ, Chonbuk Natl Univ Hosp, Dept Internal Med, Div Endocrinol & Metab,Med Sch, Jeonju, South Korea

[9] Chungnam Natl Univ, Dept Internal Med, Coll Med, Daejeon, South Korea

[10] Leju Natl Univ, Dept Internal Med, Sch Med, Jeju, South Korea

[11] Sanofi Korea, Med Dept Diabet & Cardiovasc, Seoul, South Korea

[12] Yonsei Univ, Grad Sch, Dept Internal Med, Div Endocrinol & Metab,Coll Med, Seoul, South Korea

来源：

DIABETES & METABOLISM JOURNAL | 2019年 / 43卷 / 04期

关键词：

Diabetes mellitus; type; 2; Insulin glargine; Safety; EUROPEAN ASSOCIATION; GLYCEMIC CONTROL; WEIGHT-GAIN; THERAPY; HYPERGLYCEMIA; MANAGEMENT; SITAGLIPTIN; INITIATION; STATEMENT; EFFICACY;

D O I：

10.4093/dmj.2018.0092

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页码：432 / 446

页数：15

共 21 条

[1] Inhibition of dipeptidyl peptidase-4 reduces glycemia, sustains insulin levels, and reduces glucagon levels in type 2 diabetes [J].