PMID- 27664062
OWN - NLM
STAT- MEDLINE
DCOM- 20171109
LR  - 20220409
IS  - 1932-2968 (Electronic)
IS  - 1932-2968 (Linking)
VI  - 11
IP  - 2
DP  - 2017 Mar
TI  - Ease of Use of the Insulin Glargine 300 U/mL Pen Injector in Insulin-Naive People 
      With Type 2 Diabetes.
PG  - 263-269
LID - 10.1177/1932296816668877 [doi]
AB  - BACKGROUND: Insulin glargine 300 U/mL (Gla-300) contains the same active 
      ingredient as glargine 100 U/mL (Gla-100), and provides the same number of units 
      in one-third of the volume. The SoloSTAR((R)) injector pen has been modified to 
      ensure accurate administration of this reduced volume and to improve user 
      experience. METHODS: Insulin- and pen-naive adults with type 2 diabetes (T2DM) 
      inadequately controlled with oral antihyperglycemic drugs, who had glycated 
      hemoglobin (HbA1c) levels of 7.0-11.0 % (53-97 mmol/mol) were studied. They 
      received once-daily Gla-300 in this 4-week, multicenter, open-label, single-arm 
      study (NCT02227212). Ease of use/ease of learning (the primary endpoint), 
      glycemic control, safety, and reliability of the disposable (prefilled) Gla-300 
      injector pen (secondary endpoints) were evaluated. RESULTS: At week 4, 95.0% of 
      40 participating subjects assessed the pen as excellent/good and none as 
      poor/very poor; 97.5% would recommend it to others. Total Diabetes Treatment 
      Satisfaction Questionnaire scores were stable throughout the study. Mean (SD) 
      fasting plasma glucose levels decreased from 166.1 (35.0) mg/dL at baseline to 
      124.2 (41.1) mg/dL at week 4. No product technical complaints (PTCs) or adverse 
      events (AEs) related to PTCs were reported. The number of subjects experiencing 
      hypoglycemic events of any kind and the incidence of AEs were low. No serious AEs 
      were reported. CONCLUSIONS: The Gla-300 injector pen is easy to use and easy to 
      learn to use, with demonstrable reliability and high degrees of acceptance and 
      treatment satisfaction. Once-daily Gla-300 basal insulin treatment was well 
      tolerated and effective in pen- and insulin-naive adult T2DM subjects.
FAU - Pohlmeier, Harald
AU  - Pohlmeier H
AD  - 1 Center for Diabetes and Vascular Disease, Muenster, Germany.
FAU - Berard, Lori
AU  - Berard L
AD  - 2 Winnipeg Regional Health Authority Health Sciences Centre, Winnipeg, MB, 
      Canada.
FAU - Brulle-Wohlhueter, Claire
AU  - Brulle-Wohlhueter C
AD  - 3 Sanofi, Paris, France.
FAU - Wu, Junlong
AU  - Wu J
AD  - 4 Sanofi China, Beijing, China.
FAU - Dahmen, Raphael
AU  - Dahmen R
AD  - 5 Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.
FAU - Nowotny, Irene
AU  - Nowotny I
AD  - 5 Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.
FAU - Klonoff, David
AU  - Klonoff D
AD  - 6 Diabetes Research Institute, Mills-Peninsula Health Services, San Mateo, CA, 
      USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02227212
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20160925
PL  - United States
TA  - J Diabetes Sci Technol
JT  - Journal of diabetes science and technology
JID - 101306166
RN  - 0 (Hypoglycemic Agents)
RN  - 2ZM8CX04RZ (Insulin Glargine)
SB  - IM
CIN - J Diabetes Sci Technol. 2017 Mar;11(2):270-271. PMID: 28264184
MH  - Aged
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Disposable Equipment
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/*administration & dosage
MH  - Injections, Subcutaneous
MH  - Insulin Glargine/*administration & dosage
MH  - Male
MH  - Middle Aged
MH  - Patient Satisfaction
MH  - Syringes
PMC - PMC5478028
OTO - NOTNLM
OT  - SoloSTAR
OT  - ease of learning
OT  - ease of use
OT  - insulin glargine
COIS- Declaration of Conflicting Interests: The author(s) declared the following 
      potential conflicts of interest with respect to the research, authorship, and/or 
      publication of this article: HP has no conflicts of interest to declare. LB is a 
      consultant and participates in speaker bureaus for Abbott, AstraZeneca, Bayer, 
      BD, MontMed, Boehringer Ingelheim, Eli Lilly Canada, Janssen, Lifescan, Merck, 
      Novo Nordisk, Sanofi. CB-W, JW, RD, and IN are employees of Sanofi. DK is a 
      consultant for Ascensia, Lifecare, and Voluntis. He has received research support 
      from Boehringer Ingelheim, BMS, Eli Lilly, Intarcia, Janssen, and Novo Nordisk, 
      and owns stocks/shares in Tempramed.
EDAT- 2016/09/25 06:00
MHDA- 2017/11/10 06:00
PMCR- 2018/03/01
CRDT- 2016/09/25 06:00
PHST- 2016/09/25 06:00 [pubmed]
PHST- 2017/11/10 06:00 [medline]
PHST- 2016/09/25 06:00 [entrez]
PHST- 2018/03/01 00:00 [pmc-release]
AID - 1932296816668877 [pii]
AID - 10.1177_1932296816668877 [pii]
AID - 10.1177/1932296816668877 [doi]
PST - ppublish
SO  - J Diabetes Sci Technol. 2017 Mar;11(2):263-269. doi: 10.1177/1932296816668877. 
      Epub 2016 Sep 25.