5 :: KDA, Korean Diabetes Association ::
Subject    :    [2019 Aug;43(4)] 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
Writer KDA
Date 2019-10-10 16:42:11 Hit 2,617
LINK URL https://e-dmj.org/search.php?where=aview&id=10.4093/dmj.2018.0092&code=2004DMJ&vmode=FULL (Click 29)
Diabetes Metab J. 2019 Aug;43(4):432-446. English.
Published online Jun 19, 2019.  https://doi.org/10.4093/dmj.2018.0092
Copyright © 2019 Korean Diabetes Association
   
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
Yu Mi Kang,1,* Chang Hee Jung,1,* Seung-Hwan Lee,2 Sang-Wook Kim,3 Kee-Ho Song,4 Sin Gon Kim,5 Jae Hyeon Kim,6 Young Min Cho,7 Tae Sun Park,8 Bon Jeong Ku,9 Gwanpyo Koh,10 Dol Mi Kim,11 Byung-Wan Lee,12 and Joong-Yeol Park1
1Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
2Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
3Department of Internal Medicine, Kangwon National University School of Medicine, Chuncheon, Korea.
4Department of Internal Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, Korea.
5Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.
6Division of Endocrinology and Metabolism, Department of Medicine, Thyroid Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
7Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
8Division of Endocrinology and Metabolism, Department of Internal Medicine, Chonbuk National University Hospital, Chonbuk National University Medical School, Jeonju, Korea.
9Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea.
10Department of Internal Medicine, Jeju National University School of Medicine, Jeju, Korea.
11Medical Department of Diabetes and Cardiovascular, Sanofi-Korea, Seoul, Korea.
12Division of Endocrinology and Metabolism, Department of Internal Medicine, Graduate School, Yonsei University College of Medicine, Seoul, Korea.

Corresponding author: Joong-Yeol Park. Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea. Email: jypark@amc.seoul.kr Corresponding author: Byung-Wan Lee. Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea. Email: bwanlee@yuhs.ac.kr

 

*Yu Mi Kang and Chang Hee Jung contributed equally to this study as first authors.
 
Received June 05, 2018; Accepted December 08, 2018.

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

 
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.

   
Keywords:
Diabetes mellitus, type 2; Insulin glargine; Safety
 

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