PMID- 32334592 OWN - NLM STAT- MEDLINE DCOM- 20200825 LR - 20200825 IS - 1475-2840 (Electronic) IS - 1475-2840 (Linking) VI - 19 IP - 1 DP - 2020 Apr 25 TI - Comparison of the effects of twice-daily exenatide and insulin on carotid intima-media thickness in type 2 diabetes mellitus patients: a 52-week randomized, open-label, controlled trial. PG - 48 LID - 10.1186/s12933-020-01014-7 [doi] LID - 48 AB - BACKGROUND: Exenatide, a glucagon like peptide 1 analog, has been suggested to reduce the cardiovascular disease risk factors, such as body weight, blood pressure and subclinical atherosclerosis in patients with type 2 diabetes mellitus (T2DM). This was the first randomized, open-label, controlled trial to compare the effects of exenatide versus insulin on subclinical atherosclerosis, as assessed by carotid-intima media thickness (CIMT), in patients with T2DM. METHODS: A total of 66 patients with T2DM admitted from March 10, 2015 to June 20, 2017 in the Department of Endocrinology, Beijing Hospital were randomized to receive twice-daily exenatide or aspartate 70/30 insulin for 52 weeks. The primary endpoint was change from baseline in CIMT, and secondary endpoints included changes at week 52 from baseline in body weight, glycemic markers, lipid metabolism markers, blood pressure, C-reactive protein, fibrinogen, 8-hydroxydeoxyguanosine, irisin, and brain natriuretic peptide. RESULTS: Exenatide more significantly reduced the CIMT from baseline compared with insulin after 52 weeks, with a mean difference of - 0.14 mm (95% interval confidence: - 0.25, - 0.02; P = 0.016). Weight and body mass index were both significantly reduced in the exenatide group over 52 weeks. Exenatide reduced total lipoprotein and low-density lipoprotein cholesterol levels more significantly than insulin at weeks 16 and 40. Correlation analyses showed that CIMT was positively correlated with low-density lipoprotein cholesterol. CONCLUSIONS: Twice-daily exenatide could prevent atherosclerosis progression in patients with T2DM over a 52-week treatment period compared with insulin therapy. Trial registration Chinese Clinical Trial Registry ChiCTR-1800015658. FAU - Zhang, Jie AU - Zhang J AD - Department of Endocrinology, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Graduate School of Peking Union Medical College, No. 1 Dahua Road, Dong Dan, Beijing, 100730, P. R. China. FAU - Xian, Tong-Zhang AU - Xian TZ AD - Department of Endocrinology, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, No. 1 Dahua Road, Dong Dan, Beijing, 100730, P. R. China. FAU - Wu, Ming-Xiao AU - Wu MX AD - Department of Ultrasound, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, No. 1 Dahua Road, Dong Dan, Beijing, 100730, P. R. China. FAU - Li, Chen AU - Li C AD - Department of Ultrasound, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, No. 1 Dahua Road, Dong Dan, Beijing, 100730, P. R. China. FAU - Pan, Qi AU - Pan Q AD - Department of Endocrinology, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, No. 1 Dahua Road, Dong Dan, Beijing, 100730, P. R. China. panqi621@126.com. FAU - Guo, Li-Xin AU - Guo LX AD - Department of Endocrinology, Beijing Hospital, National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Graduate School of Peking Union Medical College, No. 1 Dahua Road, Dong Dan, Beijing, 100730, P. R. China. glx1218@163.com. LA - eng SI - ChiCTR/ChiCTR-1800015658 PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20200425 PL - England TA - Cardiovasc Diabetol JT - Cardiovascular diabetology JID - 101147637 RN - 0 (Blood Glucose) RN - 0 (Hypoglycemic Agents) RN - 0 (Incretins) RN - 9P1872D4OL (Exenatide) RN - D933668QVX (Insulin Aspart) SB - IM MH - Adult MH - Aged MH - Beijing MH - Blood Glucose/drug effects/metabolism MH - Carotid Arteries/diagnostic imaging/*drug effects MH - Carotid Artery Diseases/diagnostic imaging/*drug therapy MH - *Carotid Intima-Media Thickness MH - Diabetes Mellitus, Type 2/blood/diagnosis/*drug therapy MH - Disease Progression MH - Drug Administration Schedule MH - Exenatide/*administration & dosage/adverse effects MH - Female MH - Humans MH - Hypoglycemic Agents/*administration & dosage/adverse effects MH - Incretins/*administration & dosage/adverse effects MH - Insulin Aspart/*administration & dosage/adverse effects MH - Male MH - Middle Aged MH - Predictive Value of Tests MH - Time Factors MH - Treatment Outcome MH - Young Adult PMC - PMC7183674 OTO - NOTNLM OT - Carotid intima-media thickness OT - Exenatide OT - Insulin OT - Low-density lipoprotein cholesterol COIS- The authors declare that they have no competing interests. EDAT- 2020/04/27 06:00 MHDA- 2020/08/26 06:00 PMCR- 2020/04/25 CRDT- 2020/04/27 06:00 PHST- 2019/09/25 00:00 [received] PHST- 2020/03/16 00:00 [accepted] PHST- 2020/04/27 06:00 [entrez] PHST- 2020/04/27 06:00 [pubmed] PHST- 2020/08/26 06:00 [medline] PHST- 2020/04/25 00:00 [pmc-release] AID - 10.1186/s12933-020-01014-7 [pii] AID - 1014 [pii] AID - 10.1186/s12933-020-01014-7 [doi] PST - epublish SO - Cardiovasc Diabetol. 2020 Apr 25;19(1):48. doi: 10.1186/s12933-020-01014-7.