PMID- 31237133
OWN - NLM
STAT- MEDLINE
DCOM- 20200527
LR  - 20221207
IS  - 2233-6079 (Print)
IS  - 2233-6087 (Electronic)
IS  - 2233-6079 (Linking)
VI  - 43
IP  - 4
DP  - 2019 Aug
TI  - 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.
PG  - 432-446
LID - 10.4093/dmj.2018.0092 [doi]
AB  - 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.
CI  - Copyright (c) 2019 Korean Diabetes Association.
FAU - Kang, Yu Mi
AU  - Kang YM
AUID- ORCID: 0000-0002-6272-0666
AD  - Department of Internal Medicine, Asan Medical Center, University of Ulsan College 
      of Medicine, Seoul, Korea.
FAU - Jung, Chang Hee
AU  - Jung CH
AUID- ORCID: 0000-0003-4043-2396
AD  - Department of Internal Medicine, Asan Medical Center, University of Ulsan College 
      of Medicine, Seoul, Korea.
FAU - Lee, Seung Hwan
AU  - Lee SH
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul 
      St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 
      Seoul, Korea.
FAU - Kim, Sang Wook
AU  - Kim SW
AD  - Department of Internal Medicine, Kangwon National University School of Medicine, 
      Chuncheon, Korea.
FAU - Song, Kee Ho
AU  - Song KH
AD  - Department of Internal Medicine, Konkuk University Medical Center, Konkuk 
      University School of Medicine, Seoul, Korea.
FAU - Kim, Sin Gon
AU  - Kim SG
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea 
      University College of Medicine, Seoul, Korea.
FAU - Kim, Jae Hyeon
AU  - Kim JH
AD  - Division of Endocrinology and Metabolism, Department of Medicine, Thyroid Center, 
      Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
FAU - Cho, Young Min
AU  - Cho YM
AD  - Department of Internal Medicine, Seoul National University Hospital, Seoul 
      National University College of Medicine, Seoul, Korea.
FAU - Park, Tae Sun
AU  - Park TS
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, 
      Chonbuk National University Hospital, Chonbuk National University Medical School, 
      Jeonju, Korea.
FAU - Ku, Bon Jeong
AU  - Ku BJ
AD  - Department of Internal Medicine, Chungnam National University College of 
      Medicine, Daejeon, Korea.
FAU - Koh, Gwanpyo
AU  - Koh G
AD  - Department of Internal Medicine, Jeju National University School of Medicine, 
      Jeju, Korea.
FAU - Kim, Dol Mi
AU  - Kim DM
AD  - Medical Department of Diabetes and Cardiovascular, Sanofi-Korea, Seoul, Korea.
FAU - Lee, Byung Wan
AU  - Lee BW
AUID- ORCID: 0000-0002-9899-4992
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, 
      Graduate School, Yonsei University College of Medicine, Seoul, Korea. 
      bwanlee@yuhs.ac.kr.
FAU - Park, Joong Yeol
AU  - Park JY
AUID- ORCID: 0000-0002-9823-407X
AD  - Department of Internal Medicine, Asan Medical Center, University of Ulsan College 
      of Medicine, Seoul, Korea. jypark@amc.seoul.kr.
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20190619
PL  - Korea (South)
TA  - Diabetes Metab J
JT  - Diabetes & metabolism journal
JID - 101556588
RN  - 0 (Blood Glucose)
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Sulfonylurea Compounds)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 2ZM8CX04RZ (Insulin Glargine)
RN  - 9100L32L2N (Metformin)
MH  - Aged
MH  - Blood Glucose/analysis
MH  - Body Weight/drug effects
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Dipeptidyl-Peptidase IV Inhibitors/adverse effects/*therapeutic use
MH  - Drug Therapy, Combination
MH  - Female
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemia/chemically induced
MH  - Hypoglycemic Agents/adverse effects/*therapeutic use
MH  - Insulin Glargine/*adverse effects/*therapeutic use
MH  - Male
MH  - Metformin/adverse effects/*therapeutic use
MH  - Middle Aged
MH  - Sulfonylurea Compounds/adverse effects/*therapeutic use
MH  - Treatment Outcome
PMC - PMC6712234
OTO - NOTNLM
OT  - Diabetes mellitus, type 2
OT  - Insulin glargine
OT  - Safety
COIS- Sponsorship for this study and article processing charges was funded by 
      Sanofi-Aventis Korea. Dol Mi Kim is an employee at Sanofi-Aventis Korea. No 
      potential conflict of interest relevant to this article was reported except for 
      her.
EDAT- 2019/06/27 06:00
MHDA- 2019/06/27 06:01
PMCR- 2019/08/01
CRDT- 2019/06/26 06:00
PHST- 2018/06/05 00:00 [received]
PHST- 2018/12/08 00:00 [accepted]
PHST- 2019/06/27 06:00 [pubmed]
PHST- 2019/06/27 06:01 [medline]
PHST- 2019/06/26 06:00 [entrez]
PHST- 2019/08/01 00:00 [pmc-release]
AID - 43.e37 [pii]
AID - 10.4093/dmj.2018.0092 [doi]
PST - ppublish
SO  - Diabetes Metab J. 2019 Aug;43(4):432-446. doi: 10.4093/dmj.2018.0092. Epub 2019 
      Jun 19.