PMID- 25036533
OWN - NLM
STAT- MEDLINE
DCOM- 20150715
LR  - 20221207
IS  - 1557-8593 (Electronic)
IS  - 1520-9156 (Print)
IS  - 1520-9156 (Linking)
VI  - 16
IP  - 10
DP  - 2014 Oct
TI  - Liraglutide's safety, tolerability, pharmacokinetics, and pharmacodynamics in 
      pediatric type 2 diabetes: a randomized, double-blind, placebo-controlled trial.
PG  - 679-87
LID - 10.1089/dia.2013.0366 [doi]
AB  - BACKGROUND: The prevalence of type 2 diabetes (T2D) in youth is increasing. 
      Treatment options beyond metformin and insulin are needed. The safety, 
      tolerability, pharmacokinetics, and pharmacodynamics of liraglutide once daily in 
      youth (10-17 years old) with T2D were investigated in a randomized, double-blind, 
      placebo-controlled trial. SUBJECTS AND METHODS: Youth treated with diet/exercise 
      alone or with metformin and having a hemoglobin A1c (HbA1c) level of 6.5-11% were 
      randomized to liraglutide (n=14) or placebo (n=7). Starting at 0.3 mg/day, doses 
      were escalated weekly to 0.6, 0.9, 1.2, and 1.8 mg/day (or placebo equivalent) 
      for 5 weeks. RESULTS: Nineteen participants completed the trial. Baseline 
      characteristics were similar between groups, with mean (SD) values for age of 
      14.8 (2.2) years, weight of 113.2 (35.6) kg (range, 57-214 kg), diabetes duration 
      of 1.7 (1.4) years, and HbA1c level of 8.1% (1.2%). No serious adverse events 
      (AEs), including severe hypoglycemia, occurred. Transient gastrointestinal AEs 
      were most common at lower liraglutide doses during dose escalation. No 
      significant changes in safety and tolerability parameters occurred. There was no 
      evidence of pancreatitis or lipase elevations above three times the upper normal 
      limit; calcitonin levels remained within the normal range. For liraglutide 1.8 
      mg, mean half-life was 12 h, and clearance was 1.7 L/h. After 5 weeks, the 
      decline in HbA1c level was greater with liraglutide versus placebo (-0.86 vs. 
      0.04%, P=0.0007), whereas mean body weight remained stable (-0.50 vs. -0.54 kg, 
      P=0.9703). CONCLUSIONS: Liraglutide was well tolerated in youth with T2D, with 
      safety, tolerability, and pharmacokinetic profiles similar to profiles in adults.
FAU - Klein, David J
AU  - Klein DJ
AD  - 1 Cincinnati Children's Hospital Medical Center , Cincinnati, Ohio.
FAU - Battelino, Tadej
AU  - Battelino T
FAU - Chatterjee, D J
AU  - Chatterjee DJ
FAU - Jacobsen, Lisbeth V
AU  - Jacobsen LV
FAU - Hale, Paula M
AU  - Hale PM
FAU - Arslanian, Silva
AU  - Arslanian S
CN  - NN2211-1800 Study Group
LA  - eng
SI  - ClinicalTrials.gov/NCT00943501
GR  - G0800661/MRC_/Medical Research Council/United Kingdom
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140718
PL  - United States
TA  - Diabetes Technol Ther
JT  - Diabetes technology & therapeutics
JID - 100889084
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 839I73S42A (Liraglutide)
RN  - 89750-14-1 (Glucagon-Like Peptide 1)
SB  - IM
MH  - Adolescent
MH  - Age of Onset
MH  - Belgium/epidemiology
MH  - Blood Glucose/*drug effects/metabolism
MH  - Body Weight/drug effects
MH  - Child
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy/epidemiology
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Glucagon-Like Peptide 1/administration & dosage/*analogs & 
      derivatives/pharmacokinetics/pharmacology
MH  - Glycated Hemoglobin/*drug effects/metabolism
MH  - Humans
MH  - Hypoglycemic Agents/*administration & dosage/pharmacokinetics/pharmacology
MH  - Liraglutide
MH  - Pediatric Obesity/complications/*drug therapy/epidemiology
MH  - Prevalence
MH  - Slovenia/epidemiology
MH  - Treatment Outcome
MH  - United Kingdom/epidemiology
MH  - United States/epidemiology
MH  - Weight Loss/drug effects
PMC - PMC4183917
FIR - De Schepper, J
IR  - De Schepper J
FIR - Battelino, T
IR  - Battelino T
FIR - Barrett, T
IR  - Barrett T
FIR - Bone, M
IR  - Bone M
FIR - Randell, T
IR  - Randell T
FIR - Arslanian, S
IR  - Arslanian S
FIR - Blumer, J
IR  - Blumer J
FIR - Christensen, M
IR  - Christensen M
FIR - Ferry, R
IR  - Ferry R
FIR - Hazan, L
IR  - Hazan L
FIR - Klein, D J
IR  - Klein DJ
FIR - Lopez, X
IR  - Lopez X
FIR - Neufeld, N
IR  - Neufeld N
FIR - Toltzis, P
IR  - Toltzis P
FIR - Tsalikian, E
IR  - Tsalikian E
FIR - Wadwa, R P
IR  - Wadwa RP
FIR - Wintergerst, K
IR  - Wintergerst K
EDAT- 2014/07/19 06:00
MHDA- 2015/07/16 06:00
PMCR- 2014/10/01
CRDT- 2014/07/19 06:00
PHST- 2014/07/19 06:00 [entrez]
PHST- 2014/07/19 06:00 [pubmed]
PHST- 2015/07/16 06:00 [medline]
PHST- 2014/10/01 00:00 [pmc-release]
AID - 10.1089/dia.2013.0366 [pii]
AID - 10.1089/dia.2013.0366 [doi]
PST - ppublish
SO  - Diabetes Technol Ther. 2014 Oct;16(10):679-87. doi: 10.1089/dia.2013.0366. Epub 
      2014 Jul 18.