PMID- 35112779
OWN - NLM
STAT- MEDLINE
DCOM- 20220421
LR  - 20221207
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Print)
IS  - 1462-8902 (Linking)
VI  - 24
IP  - 6
DP  - 2022 Jun
TI  - Efficacy and safety of alogliptin versus acarbose in Chinese type 2 diabetes 
      patients with high cardiovascular risk or coronary heart disease treated with 
      aspirin and inadequately controlled with metformin monotherapy or drug-naive: A 
      multicentre, randomized, open-label, prospective study (ACADEMIC).
PG  - 991-999
LID - 10.1111/dom.14661 [doi]
AB  - AIMS: To demonstrate the noninferiority of alogliptin to acarbose, in terms of 
      antidiabetic efficacy, in Chinese people with uncontrolled type 2 diabetes (T2D) 
      and high cardiovascular risk. MATERIALS AND METHODS: ACADEMIC (NCT03794336) was a 
      randomized, open-label, phase IV study conducted at 46 sites in China. 
      Antidiabetic treatment-naive or metformin-treated adults with uncontrolled T2D 
      (glycated haemoglobin [HbA1c] 58.0-97.0 mmol/mol) were randomized 2:1 to 
      alogliptin 25 mg once daily or acarbose 100 mg three times daily for 16 weeks. 
      All participants had a documented history of coronary heart disease or high 
      cardiovascular risk at screening and received aspirin (acetylsalicylic acid) 
      100 mg daily throughout the trial. The primary endpoints were change in HbA1c 
      versus baseline, and the incidence of gastrointestinal adverse events (AEs). 
      Safety and tolerability were also assessed. RESULTS: A total of 1088 participants 
      were randomized. Alogliptin was noninferior to acarbose for the change in Week-16 
      HbA1c (least-squares mean change [standard error] -11.9 [0.4] vs. -11.4 [0.5] 
      mmol/mol, respectively; difference between arms -0.5 [0.7] mmol/mol; 95% 
      confidence interval -1.9 to 0.8 mmol/mol), and was associated with a lower 
      incidence of gastrointestinal AEs (8.9% vs. 33.6%, respectively; P < 0.0001). 
      More alogliptin than acarbose recipients achieved HbA1c <53.0 mmol/mol without 
      gastrointestinal AEs (48.0% vs. 32.7%; P < 0.0001). Discontinuations due to 
      treatment-related AEs were less frequent with alogliptin than acarbose (0.3% vs. 
      2.5%). CONCLUSIONS: Glycaemic control was comparable between alogliptin and 
      acarbose, but the gastrointestinal tolerability of alogliptin was better. More 
      patients achieved target HbA1c without gastrointestinal AEs with alogliptin, 
      suggesting that this agent may be preferred in clinical practice.
CI  - (c) 2022 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & 
      Sons Ltd.
FAU - Gao, Bin
AU  - Gao B
AD  - Air Force Military Medical University Tangdu Hospital, Xi'an, China.
AD  - Air Force Military Medical University Xijing Hospital, Xi'an, China.
FAU - Gao, Weiguo
AU  - Gao W
AD  - Qingdao Endocrinology and Diabetes Hospital, Qingdao, China.
FAU - Wan, Hailong
AU  - Wan H
AD  - Panjin Central Hospital, Panjin, China.
FAU - Xu, Fengmei
AU  - Xu F
AD  - Hebi Coal Industry Co. Ltd. General Hospital, Hebi, China.
FAU - Zhou, Rong
AU  - Zhou R
AUID- ORCID: 0000-0001-6514-7503
AD  - Sanofi, Shanghai, China.
FAU - Zhang, Xia
AU  - Zhang X
AD  - Sanofi, Shanghai, China.
FAU - Ji, Qiuhe
AU  - Ji Q
AUID- ORCID: 0000-0002-4008-2974
AD  - Air Force Military Medical University Xijing Hospital, Xi'an, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT03794336
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20220322
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Piperidines)
RN  - 56HH86ZVCT (Uracil)
RN  - 9100L32L2N (Metformin)
RN  - JHC049LO86 (alogliptin)
RN  - R16CO5Y76E (Aspirin)
RN  - T58MSI464G (Acarbose)
SB  - IM
MH  - *Acarbose/adverse effects
MH  - Adult
MH  - Aspirin/therapeutic use
MH  - Coronary Disease/complications
MH  - *Diabetes Mellitus, Type 2/drug therapy
MH  - Double-Blind Method
MH  - Glycated Hemoglobin
MH  - Heart Disease Risk Factors
MH  - Humans
MH  - Hypoglycemic Agents/adverse effects
MH  - Metformin/therapeutic use
MH  - *Piperidines/adverse effects
MH  - Prospective Studies
MH  - Treatment Outcome
MH  - *Uracil/adverse effects/analogs & derivatives
PMC - PMC9314577
OTO - NOTNLM
OT  - DPP-IV inhibitor
OT  - cardiovascular disease
OT  - glycaemic control
OT  - phase IV study
OT  - randomised trial
OT  - type 2 diabetes
COIS- B.G. has attended advisory boards for Novo Nordisk, Eli Lilly and AstraZeneca, 
      and has been a speaker for Novo Nordisk, Eli Lilly, AstraZeneca, Sanofi and 
      Bayer. W.G. and F.X. have received speaker fees from Novo Nordisk and Sanofi. 
      H.W. has participated in clinical trials sponsored by Novo Nordisk, Eli Lilly and 
      Sanofi, and has been a speaker for these companies. Q.J. has been a speaker for 
      Eli Lilly, Bayer, Novo Nordisk and Sanofi, and has attended advisory boards for 
      Novo Nordisk, Eli Lilly and AstraZeneca. R.Z. and X.Z. are employees of Sanofi 
      China and hold shares and/or stock options in the company.
EDAT- 2022/02/04 06:00
MHDA- 2022/04/22 06:00
PMCR- 2022/07/26
CRDT- 2022/02/03 08:41
PHST- 2022/01/18 00:00 [revised]
PHST- 2021/11/15 00:00 [received]
PHST- 2022/01/31 00:00 [accepted]
PHST- 2022/02/04 06:00 [pubmed]
PHST- 2022/04/22 06:00 [medline]
PHST- 2022/02/03 08:41 [entrez]
PHST- 2022/07/26 00:00 [pmc-release]
AID - DOM14661 [pii]
AID - 10.1111/dom.14661 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2022 Jun;24(6):991-999. doi: 10.1111/dom.14661. Epub 2022 
      Mar 22.