PMID- 30026333
OWN - NLM
STAT- MEDLINE
DCOM- 20181010
LR  - 20221207
IS  - 1935-5548 (Electronic)
IS  - 0149-5992 (Linking)
VI  - 41
IP  - 9
DP  - 2018 Sep
TI  - A 26-Week Randomized Controlled Trial of Semaglutide Once Daily Versus 
      Liraglutide and Placebo in Patients With Type 2 Diabetes Suboptimally Controlled 
      on Diet and Exercise With or Without Metformin.
PG  - 1926-1937
LID - 10.2337/dc17-2381 [doi]
AB  - OBJECTIVE: To investigate the efficacy and safety of once-daily semaglutide in 
      comparison with once-daily liraglutide and placebo in patients with type 2 
      diabetes. RESEARCH DESIGN AND METHODS: This 26-week, multicenter, double-blind 
      trial involved patients diagnosed with type 2 diabetes with HbA(1c) 7.0-10.0% 
      (53-86 mmol/mol) and treated with diet and exercise with or without metformin. 
      Patients were randomized 2:2:1 to once-daily semaglutide, liraglutide, or placebo 
      in one of four volume-matched doses (semaglutide 0.05, 0.1, 0.2, or 0.3 mg and 
      liraglutide 0.3, 0.6, 1.2, or 1.8 mg, with both compared within each 
      volume-matched dose group). Primary end point was change in HbA(1c) from baseline 
      to week 26. RESULTS: In total, 705 randomized patients were exposed to trial 
      products. At week 26, a dose-dependent change in HbA(1c) was observed with 
      semaglutide from -1.1% (0.05 mg) to -1.9% (0.3 mg) and with liraglutide from 
      -0.5% (0.3 mg) to -1.3% (1.8 mg) (all P < 0.001 in favor of volume-matched 
      semaglutide dose). Change with pooled placebo was -0.02% (P < 0.0001 vs. 
      semaglutide). Gastrointestinal (GI) disorders were the most common adverse events 
      (AEs) with semaglutide and liraglutide, occurring in 32.8-54.0% and 21.9-41.5% of 
      patients, respectively. CONCLUSIONS: Once-daily semaglutide at doses up to 0.3 
      mg/day resulted in greater reductions in HbA(1c) compared with liraglutide or 
      placebo but with a higher frequency of GI AEs.
CI  - (c) 2018 by the American Diabetes Association.
FAU - Lingvay, Ildiko
AU  - Lingvay I
AUID- ORCID: 0000-0001-7006-7401
AD  - University of Texas Southwestern Medical Center at Dallas, Dallas, TX.
FAU - Desouza, Cyrus V
AU  - Desouza CV
AD  - University of Nebraska Medical Center, Omaha, NE.
FAU - Lalic, Katarina S
AU  - Lalic KS
AD  - Faculty of Medicine, University of Belgrade, and Clinic for Endocrinology, 
      Diabetes and Metabolic Diseases, Clinical Center of Serbia, Belgrade, Serbia.
FAU - Rose, Ludger
AU  - Rose L
AD  - Institute for Diabetes Research in Munster, Munster, Germany.
FAU - Hansen, Thomas
AU  - Hansen T
AD  - Novo Nordisk A/S, Soborg, Denmark.
FAU - Zacho, Jeppe
AU  - Zacho J
AD  - Novo Nordisk A/S, Soborg, Denmark.
FAU - Pieber, Thomas R
AU  - Pieber TR
AUID- ORCID: 0000-0003-3554-0405
AD  - Medical University of Graz, Graz, Austria thomas.pieber@medunigraz.at.
LA  - eng
SI  - ClinicalTrials.gov/NCT02461589
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20180719
PL  - United States
TA  - Diabetes Care
JT  - Diabetes care
JID - 7805975
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Placebos)
RN  - 53AXN4NNHX (semaglutide)
RN  - 62340-29-8 (Glucagon-Like Peptides)
RN  - 839I73S42A (Liraglutide)
RN  - 9100L32L2N (Metformin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Combined Modality Therapy
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy/therapy
MH  - *Diet
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Exercise/*physiology
MH  - Female
MH  - Glucagon-Like Peptides/*administration & dosage/adverse effects
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Liraglutide/*administration & dosage/adverse effects
MH  - Male
MH  - Metformin/*administration & dosage/adverse effects
MH  - Middle Aged
MH  - Placebos
MH  - Treatment Outcome
EDAT- 2018/07/22 06:00
MHDA- 2018/10/12 06:00
CRDT- 2018/07/21 06:00
PHST- 2017/11/13 00:00 [received]
PHST- 2018/06/18 00:00 [accepted]
PHST- 2018/07/22 06:00 [pubmed]
PHST- 2018/10/12 06:00 [medline]
PHST- 2018/07/21 06:00 [entrez]
AID - dc17-2381 [pii]
AID - 10.2337/dc17-2381 [doi]
PST - ppublish
SO  - Diabetes Care. 2018 Sep;41(9):1926-1937. doi: 10.2337/dc17-2381. Epub 2018 Jul 
      19.