PMID- 19706990
OWN - NLM
STAT- MEDLINE
DCOM- 20100218
LR  - 20221207
IS  - 1348-4540 (Electronic)
IS  - 0918-8959 (Linking)
VI  - 56
IP  - 8
DP  - 2009
TI  - Safety, tolerability, pharmacokinetics, and pharmacodynamics of exenatide once 
      weekly in Japanese patients with type 2 diabetes.
PG  - 951-62
AB  - This randomized, placebo-controlled, double-blind, parallel study assessed the 
      safety, tolerability, pharmacokinetics, and pharmacodynamics of exenatide once 
      weekly (QW) in 30 Japanese patients with type 2 diabetes (T2D) suboptimally 
      controlled by diet and exercise alone or combined with biguanide, sulfonylurea, 
      thiazolidinedione, or combinations of these agents (58.6% male; 58+/-9 years; 
      body mass index 26.3+/-2.9 kg/m(2); hemoglobin A(1c) [HbA(1c)] 7.4+/-0.8%; 
      fasting plasma glucose [FPG] 156.1+/-29.1 mg/dL; duration of T2D 6+/-5 years; 
      means +/- SD). Patients were randomized in a 1:1:1 ratio to subcutaneous placebo 
      QW, exenatide QW 0.8 mg, or exenatide QW 2.0 mg for 10 weeks. All evaluable 
      patients were analyzed (placebo QW, n=10; exenatide QW 0.8 mg, n=10; exenatide QW 
      2.0 mg, n=9), unless otherwise stated. Steady-state plasma exenatide 
      concentrations were observed by Week 8 of the study. For the evaluable 
      pharmacokinetic population, geometric mean (90% confidence interval) steady-state 
      plasma concentrations (pg/mL) were 81.2 (68.3-96.4) and 344.5 (256.5-462.7) with 
      exenatide QW 0.8 mg (n=8) and exenatide QW 2.0 mg (n=5), respectively. 
      Baseline-to-Week 10 glycemic improvements with placebo QW, exenatide QW 0.8 mg, 
      and exenatide QW 2.0 mg, respectively, were: HbA(1c) (%): -0.4+/-0.3, -1.0+/-0.7, 
      and -1.5+/-0.7; FPG (mg/dL): -20.5+/-20.4, -25.2+/-10.9, and -50.8+/-27.8; and 
      2-hour postprandial plasma glucose excursions (mg/dL): -8.8+/-26.9, -50.0+/-41.1, 
      and -59.7+/-26.8 (means +/- SD). No serious adverse events (AEs) were reported 
      and no AEs led to study discontinuation in any group. The most frequent AE 
      observed was mild-to-moderate injection site induration. No serious hypoglycemia 
      was reported. Exenatide QW for 10 weeks was well tolerated and improved 
      short-term glycemic control in Japanese patients with suboptimally controlled 
      T2D.
FAU - Iwamoto, Kazuya
AU  - Iwamoto K
AD  - Lilly Research Laboratories Japan, Eli Lilly Japan K.K., Kobe, Japan.
FAU - Nasu, Risa
AU  - Nasu R
FAU - Yamamura, Ayuko
AU  - Yamamura A
FAU - Kothare, Prajakti A
AU  - Kothare PA
FAU - Mace, Kenneth
AU  - Mace K
FAU - Wolka, Anne M
AU  - Wolka AM
FAU - Linnebjerg, Helle
AU  - Linnebjerg H
LA  - eng
SI  - ClinicalTrials.gov/NCT00612794
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20090825
PL  - Japan
TA  - Endocr J
JT  - Endocrine journal
JID - 9313485
RN  - 0 (Blood Glucose)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Peptides)
RN  - 0 (Placebos)
RN  - 0 (Venoms)
RN  - 9P1872D4OL (Exenatide)
SB  - IM
MH  - Aged
MH  - Algorithms
MH  - Asian People
MH  - Blood Glucose/metabolism
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy/metabolism
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Exenatide
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/administration & dosage/adverse effects/pharmacokinetics
MH  - Injections
MH  - Male
MH  - Middle Aged
MH  - Peptides/*administration & dosage/*adverse effects/*pharmacokinetics
MH  - Placebos
MH  - Venoms/*administration & dosage/*adverse effects/*pharmacokinetics
EDAT- 2009/08/27 09:00
MHDA- 2010/02/19 06:00
CRDT- 2009/08/27 09:00
PHST- 2009/08/27 09:00 [entrez]
PHST- 2009/08/27 09:00 [pubmed]
PHST- 2010/02/19 06:00 [medline]
AID - JST.JSTAGE/endocrj/K09E-147 [pii]
AID - 10.1507/endocrj.k09e-147 [doi]
PST - ppublish
SO  - Endocr J. 2009;56(8):951-62. doi: 10.1507/endocrj.k09e-147. Epub 2009 Aug 25.