PMID- 35679098
OWN - NLM
STAT- MEDLINE
DCOM- 20220801
LR  - 20231202
IS  - 1935-5548 (Electronic)
IS  - 0149-5992 (Print)
IS  - 0149-5992 (Linking)
VI  - 45
IP  - 8
DP  - 2022 Aug 1
TI  - Once-Weekly Exenatide in Youth With Type 2 Diabetes.
PG  - 1833-1840
LID - 10.2337/dc21-2275 [doi]
AB  - OBJECTIVE: Approved treatments for type 2 diabetes in pediatric patients include 
      metformin, liraglutide, and insulin. However, approximately one-half of the youth 
      fail metformin monotherapy within 1 year, insulin therapy is associated with 
      challenges, and liraglutide requires daily injections. Consequently, the efficacy 
      and safety of once-weekly injections of exenatide for the treatment of youth with 
      type 2 diabetes was evaluated. RESEARCH DESIGN AND METHODS: Participants (aged 10 
      to <18 years) were randomized (5:2) to once-weekly exenatide 2 mg or placebo, 
      respectively. The primary efficacy end point was change in glycated hemoglobin 
      from baseline to week 24. Secondary efficacy end points were also evaluated, and 
      the frequency of adverse events (AEs) was assessed. RESULTS: A total of 83 
      participants were randomized (exenatide, 59; placebo, 24) and 72 completed 
      24-week treatment (exenatide, 49; placebo, 23). At 24 weeks, the least squares 
      mean change in glycated hemoglobin was -0.36% for the exenatide and +0.49% for 
      the placebo groups (between-group difference, -0.85%; 95% CI -1.51, -0.19; P = 
      0.012). Nonsignificant least squares mean differences from baseline to 24 weeks 
      favoring exenatide were observed: fasting glucose -21.6 mg/dL (-49.0, 5.7; P = 
      0.119), systolic blood pressure -2.8 mmHg (-8.0, 2.4; P = 0.284), and body weight 
      -1.22 kg (-3.59, 1.15; P = 0.307). AEs occurred in 36 (61.0%) and 17 (73.9%) 
      participants in the exenatide and placebo groups, respectively. CONCLUSIONS: In 
      youth with type 2 diabetes suboptimally controlled with current treatments, 
      once-weekly exenatide reduced glycated hemoglobin at 24 weeks and was well 
      tolerated.
CI  - (c) 2022 by the American Diabetes Association.
FAU - Tamborlane, William V
AU  - Tamborlane WV
AUID- ORCID: 0000-0002-9928-559X
AD  - Department of Pediatrics, Yale School of Medicine, New Haven, CT.
FAU - Bishai, Raafat
AU  - Bishai R
AD  - Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals 
      R&D, AstraZeneca, Gaithersburg, MD.
FAU - Geller, David
AU  - Geller D
AD  - The Center for Endocrinology, Diabetes, and Metabolism, Children's Hospital Los 
      Angeles, and Keck School of Medicine, University of Southern California, Los 
      Angeles, CA.
FAU - Shehadeh, Naim
AU  - Shehadeh N
AD  - Bruce Rappaport Faculty of Medicine, Technion, and Institute of Diabetes and 
      Endocrinology, Rambam Health Care Campus, Haifa, Israel.
FAU - Al-Abdulrazzaq, Dalia
AU  - Al-Abdulrazzaq D
AD  - Department of Population Health, Dasman Diabetes Institute, Dasman, Kuwait.
AD  - Department of Pediatrics, Faculty of Medicine, Kuwait University, Kuwait City, 
      Kuwait.
FAU - Vazquez, Evelina Manica
AU  - Vazquez EM
AD  - Sociedad de Metabolismo y Corazon S.C., Veracruz, Mexico.
FAU - Karoly, Eva
AU  - Karoly E
AD  - St. Rokus Hospital, Baja, Hungary.
FAU - Troja, Tunde
AU  - Troja T
AD  - St. Rokus Hospital, Baja, Hungary.
FAU - Doehring, Orlando
AU  - Doehring O
AD  - Biometrics, Late-Stage Development, Cardiovascular, Renal and Metabolism, 
      BioPharmaceuticals R&D, AstraZeneca, Cambridge, U.K.
FAU - Carter, Debra
AU  - Carter D
AD  - Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals 
      R&D, AstraZeneca, Gaithersburg, MD.
FAU - Monyak, John
AU  - Monyak J
AD  - Biometrics, Late-Stage Development, Cardiovascular, Renal and Metabolism, 
      BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD.
FAU - Sjostrom, C David
AU  - Sjostrom CD
AD  - Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals 
      R&D, AstraZeneca, Gothenburg, Sweden.
LA  - eng
SI  - ClinicalTrials.gov/NCT01554618
SI  - figshare/10.2337/figshare.19638627
GR  - P30 DK045735/DK/NIDDK NIH HHS/United States
GR  - UL1 TR001863/TR/NCATS NIH HHS/United States
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Diabetes Care
JT  - Diabetes care
JID - 7805975
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
RN  - 0 (Peptides)
RN  - 0 (Venoms)
RN  - 839I73S42A (Liraglutide)
RN  - 9100L32L2N (Metformin)
RN  - 9P1872D4OL (Exenatide)
SB  - IM
MH  - Adolescent
MH  - Blood Glucose
MH  - Child
MH  - *Diabetes Mellitus, Type 2/complications
MH  - Exenatide
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemic Agents/adverse effects
MH  - Insulin/therapeutic use
MH  - Liraglutide/therapeutic use
MH  - *Metformin/therapeutic use
MH  - Peptides/adverse effects
MH  - Venoms/adverse effects
PMC - PMC9346995
EDAT- 2022/06/10 06:00
MHDA- 2022/08/02 06:00
PMCR- 2022/07/26
CRDT- 2022/06/09 11:52
PHST- 2021/11/03 00:00 [received]
PHST- 2022/04/01 00:00 [accepted]
PHST- 2022/06/10 06:00 [pubmed]
PHST- 2022/08/02 06:00 [medline]
PHST- 2022/06/09 11:52 [entrez]
PHST- 2022/07/26 00:00 [pmc-release]
AID - 147070 [pii]
AID - 212275 [pii]
AID - 10.2337/dc21-2275 [doi]
PST - ppublish
SO  - Diabetes Care. 2022 Aug 1;45(8):1833-1840. doi: 10.2337/dc21-2275.