PMID- 32827752
OWN - NLM
STAT- MEDLINE
DCOM- 20220125
LR  - 20220125
IS  - 1878-1780 (Electronic)
IS  - 1262-3636 (Linking)
VI  - 47
IP  - 3
DP  - 2021 May
TI  - Comparison of efficacy and safety of empagliflozin vs linagliptin added to 
      premixed insulin in patients with uncontrolled type 2 diabetes: A randomized, 
      open-label study.
PG  - 101184
LID - S1262-3636(20)30103-8 [pii]
LID - 10.1016/j.diabet.2020.08.001 [doi]
AB  - AIMS: Sodium-glucose cotransporter-2 (SGLT2) inhibitors and dipeptidyl peptidase 
      (DPP)-4 inhibitors added to insulin regimens in patients with type 2 diabetes 
      mellitus (T2DM) can improve glycaemic control. This study compared the efficacy 
      and safety of empagliflozin and linagliptin added to premixed insulin therapy in 
      patients with poorly controlled T2DM. METHODS: In this 24-week, open-label, 
      parallel-design randomized controlled trial, patients with poorly controlled T2DM 
      despite a premixed insulin regimen were randomized to receive 5mg of linagliptin 
      (n=53) or 25mg of empagliflozin (n=53) for 24 weeks. RESULTS: At week 24, changes 
      in glycated haemoglobin (HbA1c) from baseline were -0.06+/-0.17% and -1.01+/-0.16% in 
      the linagliptin and empagliflozin groups, respectively, and the mean treatment 
      HbA1c difference was -0.88% (95% CI: -1.33, -0.43). At week 24, the empagliflozin 
      group showed significant reductions, compared with the linagliptin group, in 
      fasting plasma glucose (P<0.001), body weight (P<0.001), systolic blood pressure 
      (P=0.003) and total daily insulin dose (P=0.042). Hypoglycaemia was reported to 
      be slightly, and not significantly, higher in the empagliflozin group vs 
      linagliptin group (30.2% vs 22.6%, respectively; P=0.51). Similar percentages of 
      patients (1.9%) had urinary tract infections in the two groups. CONCLUSION: In 
      Asian patients with inadequately controlled T2DM while taking premixed insulin, 
      the addition of empagliflozin for 24 weeks provided better glycaemic control and 
      greater reductions in body weight and systolic blood pressure than the addition 
      of linagliptin. Clinical Trial Registration #: NCT03458715.
CI  - Copyright (c) 2020 The Author(s). Published by Elsevier Masson SAS.. All rights 
      reserved.
FAU - Liu, S-C
AU  - Liu SC
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, MacKay 
      Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical 
      College, New Taipei City, Taiwan.
FAU - Lee, C-C
AU  - Lee CC
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, MacKay 
      Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical 
      College, New Taipei City, Taiwan.
FAU - Chuang, S-M
AU  - Chuang SM
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, MacKay 
      Memorial Hospital, Taipei, Taiwan; MacKay Junior College of Medicine, Nursing and 
      Management, Taipei, Taiwan.
FAU - Sun, F-J
AU  - Sun FJ
AD  - MacKay Junior College of Medicine, Nursing and Management, Taipei, Taiwan; 
      Department of Medical Research, MacKay Memorial Hospital, Taipei, Taiwan; 
      Institute of Biomedical Informatics, National Yang Ming University, Taipei, 
      Taiwan.
FAU - Zeng, Y-H
AU  - Zeng YH
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, MacKay 
      Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical 
      College, New Taipei City, Taiwan; Institute of Public Health, National Yang Ming 
      University, Taipei, Taiwan. Electronic address: starrydouchain@gmail.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT03458715
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20200819
PL  - France
TA  - Diabetes Metab
JT  - Diabetes & metabolism
JID - 9607599
RN  - 0 (Benzhydryl Compounds)
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Glucosides)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
RN  - 0 (Sodium-Glucose Transporter 2 Inhibitors)
RN  - 3X29ZEJ4R2 (Linagliptin)
RN  - HDC1R2M35U (empagliflozin)
SB  - IM
MH  - *Benzhydryl Compounds/adverse effects
MH  - *Diabetes Mellitus, Type 2/drug therapy
MH  - Dipeptidyl-Peptidase IV Inhibitors/adverse effects
MH  - Drug Therapy, Combination/adverse effects
MH  - *Glucosides/adverse effects
MH  - Humans
MH  - Hypoglycemic Agents/administration & dosage
MH  - *Insulin/administration & dosage
MH  - *Linagliptin/adverse effects
MH  - Sodium-Glucose Transporter 2 Inhibitors/adverse effects
MH  - Treatment Outcome
OTO - NOTNLM
OT  - DPP4 inhibitor
OT  - Insulin
OT  - SGLT2 inhibitor
OT  - Type 2 diabetes
EDAT- 2020/08/23 06:00
MHDA- 2022/01/27 06:00
CRDT- 2020/08/23 06:00
PHST- 2020/06/07 00:00 [received]
PHST- 2020/08/05 00:00 [revised]
PHST- 2020/08/08 00:00 [accepted]
PHST- 2020/08/23 06:00 [pubmed]
PHST- 2022/01/27 06:00 [medline]
PHST- 2020/08/23 06:00 [entrez]
AID - S1262-3636(20)30103-8 [pii]
AID - 10.1016/j.diabet.2020.08.001 [doi]
PST - ppublish
SO  - Diabetes Metab. 2021 May;47(3):101184. doi: 10.1016/j.diabet.2020.08.001. Epub 
      2020 Aug 19.