PMID- 24631129
OWN - NLM
STAT- MEDLINE
DCOM- 20150209
LR  - 20221207
IS  - 1873-460X (Electronic)
IS  - 1056-8727 (Linking)
VI  - 28
IP  - 3
DP  - 2014 May-Jun
TI  - Continuous subcutaneous delivery of exenatide via ITCA 650 leads to sustained 
      glycemic control and weight loss for 48 weeks in metformin-treated subjects with 
      type 2 diabetes.
PG  - 393-8
LID - S1056-8727(13)00335-8 [pii]
LID - 10.1016/j.jdiacomp.2013.12.009 [doi]
AB  - AIMS: Evaluate the efficacy and tolerability of ITCA 650 in subjects with type 2 
      diabetes treated for up to 48 weeks. METHODS: This was a 24-week extension to a 
      randomized, 24-week, open-label, phase 2 study in subjects with type 2 diabetes 
      inadequately controlled with metformin. Subjects received ITCA 650 mg (20, 40, 60 
      or 80 mug/day). Mean changes for HbA1c, weight, and fasting plasma glucose (FPG) 
      were evaluated. RESULTS: Mean changes in HbA1c from baseline to week 48 ranged 
      from -0.85% to -1.51%. At week 48, >/=64% of subjects with an HbA1c </=7% at week 24 
      maintained an HbA1c </=7%. The incidence of adverse events (AEs) was dose-related 
      and ranged from 13.3% with 20 mug/day to 37.5% with 80 mug/day. Most AEs were mild 
      and transient; the incidence of nausea declined from 12.9% to 9.5% over the 
      24-week extension. One subject on ITCA 650 80 mug/day experienced mild 
      intermittent vomiting. Three (3.5%) subjects experienced severe AEs, but none 
      were considered related to study drug. CONCLUSION: Significant changes in HbA1c, 
      body weight, and FPG attained with ITCA 650 were maintained to 48 weeks. The 
      incidence of AEs was lower in the 24-week extension than in the initial 24-week 
      treatment phase.
CI  - Published by Elsevier Inc.
FAU - Henry, Robert R
AU  - Henry RR
AD  - VA San Diego Healthcare System, San Diego, CA and University of California, San 
      Diego, La Jolla, CA. Electronic address: rrhenry@vapop.ucsd.edu.
FAU - Rosenstock, Julio
AU  - Rosenstock J
AD  - Dallas Diabetes and Endocrine Center at Medical City, Dallas, TX.
FAU - Logan, Douglas
AU  - Logan D
AD  - Medpace Clinical Pharmacology Unit, Cincinnati, OH.
FAU - Alessi, Thomas
AU  - Alessi T
AD  - Intarcia Therapeutics Inc., Hayward, CA.
FAU - Luskey, Kenneth
AU  - Luskey K
AD  - Intarcia Therapeutics Inc., Hayward, CA.
FAU - Baron, Michelle A
AU  - Baron MA
AD  - Intarcia Therapeutics Inc., Hayward, CA.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140107
PL  - United States
TA  - J Diabetes Complications
JT  - Journal of diabetes and its complications
JID - 9204583
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Peptides)
RN  - 0 (Venoms)
RN  - 9100L32L2N (Metformin)
RN  - 9P1872D4OL (Exenatide)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Blood Glucose/*drug effects/metabolism
MH  - Body Weight/drug effects/physiology
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy/physiopathology
MH  - Dose-Response Relationship, Drug
MH  - Drug Therapy, Combination
MH  - Exenatide
MH  - Female
MH  - Glycated Hemoglobin/drug effects/metabolism
MH  - Humans
MH  - Hypoglycemic Agents/administration & dosage/adverse effects/*pharmacology
MH  - Infusions, Subcutaneous
MH  - Longitudinal Studies
MH  - Male
MH  - Metformin/*therapeutic use
MH  - Middle Aged
MH  - Peptides/administration & dosage/adverse effects/*pharmacology
MH  - Treatment Outcome
MH  - Venoms/administration & dosage/adverse effects/*pharmacology
MH  - Weight Loss/*drug effects/physiology
OTO - NOTNLM
OT  - Exenatide
OT  - ITCA 650
OT  - Type 2 diabetes
EDAT- 2014/03/19 06:00
MHDA- 2015/02/11 06:00
CRDT- 2014/03/18 06:00
PHST- 2013/11/03 00:00 [received]
PHST- 2013/12/20 00:00 [revised]
PHST- 2013/12/22 00:00 [accepted]
PHST- 2014/03/18 06:00 [entrez]
PHST- 2014/03/19 06:00 [pubmed]
PHST- 2015/02/11 06:00 [medline]
AID - S1056-8727(13)00335-8 [pii]
AID - 10.1016/j.jdiacomp.2013.12.009 [doi]
PST - ppublish
SO  - J Diabetes Complications. 2014 May-Jun;28(3):393-8. doi: 
      10.1016/j.jdiacomp.2013.12.009. Epub 2014 Jan 7.