PMID- 29862621
OWN - NLM
STAT- MEDLINE
DCOM- 20190128
LR  - 20240402
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Print)
IS  - 1462-8902 (Linking)
VI  - 20
IP  - 10
DP  - 2018 Oct
TI  - Achieving glycaemic control without weight gain, hypoglycaemia, or 
      gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial 
      programme.
PG  - 2426-2434
LID - 10.1111/dom.13396 [doi]
AB  - AIM: To evaluate the potential for semaglutide to help people with type 2 
      diabetes (T2D) achieve glycated haemoglobin (HbA1c) targets while avoiding 
      unwanted outcomes, such as weight gain, hypoglycaemia and gastrointestinal (GI) 
      side effects. MATERIALS AND METHODS: Data from the phase IIIa SUSTAIN 1 to 5 
      clinical trials were analysed. Participants had inadequately controlled T2D and 
      were drug-naive (SUSTAIN 1) or on a range of background treatments (SUSTAIN 2 to 
      5). The main protocol-specified composite endpoint was the proportion of 
      participants achieving HbA1c <53 mmol/mol (7.0%) at end of treatment (30 or 56 
      weeks) without weight gain and with no severe or blood glucose (BG)-confirmed 
      symptomatic hypoglycaemia. A post hoc composite endpoint was the proportion of 
      participants achieving the primary composite endpoint without moderate or severe 
      GI adverse events (AEs). RESULTS: Across the SUSTAIN trials 1 to 5, 3918 
      participants with T2D were randomized to once-weekly subcutaneous semaglutide 0.5 
      mg, 1.0 mg, or comparators (placebo, sitagliptin 100 mg, exenatide extended 
      release 2.0 mg or insulin glargine). The proportion of participants achieving 
      HbA1c <53 mmol/mol (7.0%) with no weight gain and no severe/BG-confirmed 
      symptomatic hypoglycaemia was 47% to 66% (semaglutide 0.5 mg) and 57% to 74% 
      (semaglutide 1.0 mg) vs 7% to 19% (placebo) and 16% to 29% (active comparators; 
      all P < .0001). More participants achieved the primary composite endpoint with no 
      moderate or severe GI AEs with semaglutide vs comparators (all P < .0001). 
      CONCLUSION: Semaglutide helped more people with T2D achieve HbA1c targets than 
      did comparators in the SUSTAIN 1 to 5 trials, while avoiding unwanted outcomes 
      such as weight gain, hypoglycaemia and GI side effects.
CI  - (c) 2018 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & 
      Sons Ltd.
FAU - DeVries, J Hans
AU  - DeVries JH
AD  - Department of Endocrinology, Academic Medical Centre, Amsterdam, The Netherlands.
AD  - Profil Institute for Metabolic Research, Neuss, Germany.
FAU - Desouza, Cyrus
AU  - Desouza C
AD  - Division of Diabetes Endocrinology & Metabolism, University of Nebraska Medical 
      Center, Omaha, Nebraska.
FAU - Bellary, Srikanth
AU  - Bellary S
AD  - School of Life and Health Sciences, Aston University, Birmingham, UK.
FAU - Unger, Jeffrey
AU  - Unger J
AD  - Director, Metabolic Studies, Catalina Research Institute, Chino, California.
FAU - Hansen, Oluf K H
AU  - Hansen OKH
AD  - Novo Nordisk A/S, Soborg, Denmark.
FAU - Zacho, Jeppe
AU  - Zacho J
AD  - Novo Nordisk Pharma Ltd., Tokyo, Japan.
FAU - Woo, Vincent
AU  - Woo V
AD  - Section of Endocrinology and Metabolism, Health Sciences Centre, University of 
      Manitoba, Winnipeg, Canada.
LA  - eng
GR  - Novo Nordisk A/S, Soborg, Denmark/International
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20180709
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 53AXN4NNHX (semaglutide)
RN  - 62340-29-8 (Glucagon-Like Peptides)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Blood Glucose/*drug effects/metabolism
MH  - Clinical Trials, Phase III as Topic/statistics & numerical data
MH  - Diabetes Mellitus, Type 2/*drug therapy/epidemiology
MH  - Female
MH  - Gastrointestinal Diseases/*chemically induced/epidemiology
MH  - Glucagon-Like Peptides/*therapeutic use
MH  - Glycated Hemoglobin/*drug effects/metabolism
MH  - Humans
MH  - Hypoglycemia/chemically induced
MH  - Male
MH  - Middle Aged
MH  - Multicenter Studies as Topic/statistics & numerical data
MH  - Randomized Controlled Trials as Topic/statistics & numerical data
MH  - Retrospective Studies
MH  - Weight Gain/*drug effects
PMC - PMC6175309
OTO - NOTNLM
OT  - GLP-1
OT  - glycaemic control
OT  - hypoglycaemia
OT  - type 2 diabetes
COIS- SB and VW received research grants from Novo Nordisk for the current study. CD 
      received non-financial support from Novo Nordisk for the current study. Outside 
      the submitted work, JHD received personal fees from Novo Nordisk; CD received 
      grants and personal fees from Novo Nordisk and grants from the National 
      Institutes of Health, Theracos, Sanofi and Janssen; SB received personal fees 
      from Eli Lilly, MSD, AstraZeneca, Boehringer Ingelheim, Sanofi Aventis, Novo 
      Nordisk, and Janssen; VW received grants and personal fees from Novo Nordisk, Eli 
      Lilly, Boehringer Ingelheim, AstraZeneca and Sanofi. JU participates at an 
      advisory board for Novo Nordisk. OKHH and JZ are employees of Novo Nordisk. JZ is 
      a shareholder of Novo Nordisk.
EDAT- 2018/06/05 06:00
MHDA- 2019/01/29 06:00
PMCR- 2018/10/08
CRDT- 2018/06/05 06:00
PHST- 2018/02/02 00:00 [received]
PHST- 2018/05/11 00:00 [revised]
PHST- 2018/05/25 00:00 [accepted]
PHST- 2018/06/05 06:00 [pubmed]
PHST- 2019/01/29 06:00 [medline]
PHST- 2018/06/05 06:00 [entrez]
PHST- 2018/10/08 00:00 [pmc-release]
AID - DOM13396 [pii]
AID - 10.1111/dom.13396 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2018 Oct;20(10):2426-2434. doi: 10.1111/dom.13396. Epub 2018 
      Jul 9.