Ease of Use of the Insulin Glargine 300 U/mL Pen Injector in Insulin-Naïve People With Type 2 Diabetes.
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®injector pen has been modified to ensure accurate administration of this reduced volume and to improve user experience.



Insulin- and pen-naïve 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.



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.



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-naïve adult T2DM subjects.
1 Center for Diabetes and Vascular Disease, Muenster, Germany.
Harald
H
Pohlmeier
2 Winnipeg Regional Health Authority Health Sciences Centre, Winnipeg, MB, Canada.
Lori
L
Berard
3 Sanofi, Paris, France.
Claire
C
Brulle-Wohlhueter
4 Sanofi China, Beijing, China.
Junlong
J
Wu
5 Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.
Raphael
R
Dahmen
5 Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.
Irene
I
Nowotny
6 Diabetes Research Institute, Mills-Peninsula Health Services, San Mateo, CA, USA.
David
D
Klonoff
D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004209:Disposable Equipment; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007279:Injections, Subcutaneous; D000069036:Insulin Glargine / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D013594:Syringes
D007004:Hypoglycemic Agents; D000069036:Insulin Glargine
SoloSTAR; ease of learning; ease of use; insulin glargine
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25641260
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26563324
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25150159
Diabetes Obes Metab. 2016 Apr;18(4):375-83
26662964
Diabet Med. 2012 May;29(5):682-9
22313123
QJM. 2007 Jun;100(6):345-50
17504861
Diabetes Technol Ther. 2012 Oct;14(10):926-35
22775367
Diabetes Care. 2003 Nov;26(11):3080-6
14578243
Diabetes Obes Metab. 2016 Apr;18(4):366-74
26662838
Diabetes Care. 2005 May;28(5):1245-9
15855602
Diabetes Obes Metab. 2014 Sep;16(9):873-6
24571126
Diabetes Care. 2015 Dec;38(12):2217-25
26084341
Diabetes Care. 2005 Oct;28(10):2543-5
16186296
N Engl J Med. 2012 Jul 26;367(4):319-28
22686416
Diabetes Care. 2005 Feb;28(2):254-9
15677775
J Diabetes Sci Technol. 2015 Aug 26;10 (1):125-30
26311720
Diabetes Care. 2014 Dec;37(12):3235-43
25193531
J Diabetes Sci Technol. 2015 Jul;9(4):936-8
26002837
Diabetes Care. 2014 Oct;37(10):2755-62
25078900
Value Health. 2015 Mar;18(2):198-205
25773555