Journal of Diabetes Science and Technology
`Volume 5, Issue 5, September 2011
`© Diabetes Technology Society
`
`ORIGINAL ARTICLE
`
`A Pan-European and Canadian Prospective Survey to Evaluate
`Patient Satisfaction with the SoloSTAR Insulin Injection Device
`in Type 1 and Type 2 Diabetes
`
`Nicolae Hancu, M.D., Ph.D.,1 Leszek Czupryniak, Ph.D.,2 Elisabeth Genestin, M.D.,3
`and Harald Sourij, M.D.4
`
`Abstract
`
`Objective:
`This study evaluated patient satisfaction with SoloSTAR® (sanofi-aventis), a prefilled insulin pen device for
`injection of insulin glargine or insulin glulisine.
`
`Methods:
`This was a 6-8-week multicenter (n = 652), observational, prospective Pan-European and Canadian registry
`study in patients with diabetes mellitus (n = 6542) who recently switched to or started treatment with insulin
`glargine and/or insulin glulisine using SoloSTAR or were insulin nai"ve. At the baseline visit, patients were
`asked to evaluate their satisfaction with their previous device, if applicable. After 6-8 weeks of SoloSTAR use,
`patients were asked to rate their satisfaction.
`
`Results:
`Overall, 6481 patients (mean age 54 years, 48.7% male, 72% type 2 diabetes) were analyzed in this study.
`Of these, 4995 (77.1%) patients had used insulin before the study and 1641 (32.9%) and 3395 (68.0%) patients
`had previously used prefilled and/or reusable pens, respectively. During the study, SoloSTAR was used to
`administer insulin glargine and/or insulin glulisine by 97.3% and 36.0% of patients, respectively (both: 27.0%).
`Most patients rated SoloSTAR as "excellent/good" for ease of use (97.9%), learning to use (98.3%), selecting the
`dose (97.6%), and reading the dose (95.1%). Most patients rated ease of use (88.4%) and injecting a dose (84.5%) with
`SoloSTAR as "much easier/easier" versus their previous pen. Overall, 98% planned to continue using SoloSTAR.
`No safety concerns were reported.
`
`Conclusion:
`This European and Canadian survey shows that SoloSTAR was well accepted in this large patient population.
`Most patients preferred SoloSTAR to their previous pen and planned to continue SoloSTAR use.
`
`J Diabetes Sci Technol 2011;5(5):1224-1234
`
`Author Affiliations: 1University of Medicine, Cluj-Napoca, Romania; 2Diabetology and Metabolic Diseases Department, Medical University of
`Lodz, Lodz, Poland; 3sanofi-aventis, Paris, France; and 4Division of Endocrinology and Metabolism, Medical University of Graz, Graz, Austria
`
`Abbreviations: (SD) standard deviation, (TlDM) type 1 diabetes mellitus, (T2DM) type 2 diabetes mellitus, (TEAE) treatment-emergent adverse event
`
`Keywords: European, insulin glargine, insulin glulisine, insulin pen device, patient satisfaction, SoloSTAR
`
`Corresponding Author: Nicolae Hancu, M.D., Ph.D., Clinicilor Street no 2-4, 400006 Cluj Napoca, Romania; email address nhancu@umfclui.ro
`
`1224
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`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`A Pan-European and Canadian Prospective Survey to Evaluate Patient Satisfaction
`with the SoloSTAR® Insulin Injection Device in Type 1 and Type 2 Diabetes
`
`Hancu
`
`Introduction
`
`sulin pen devices are generally perceived by patients
`l
`as being more convenient, flexible, and socially acceptable
`methods for administering insulin compared with
`traditional vial and syringe systems.1- 4 As a result,
`prefilled and disposable pens are now the predominant
`method for injecting insulin in many countries among
`patients with type 1 diabetes mellitus (TlDM) or type 2
`diabetes mellitus (T2DM). Nevertheless, the use of the vial
`and syringe still prevails in countries such as Brazil,
`India, and the United States5 due,
`in part, to the
`perceived cost of using insulin pens relative to the
`vial and syringe. This is despite evidence showing that
`the overall treatment costs incurred by patients using
`insulin pens are lower than in those who use the vial
`and syringe, as a consequence of the lower rate of
`hypoglycemia associated with insulin pen use3,6 and the
`higher rates of adherence to treatment that are achieved
`with insulin pens.7
`
`In addition to the perceived convenience, flexibility, and
`social acceptability, insulin pens are able to accurately
`administer the required doses of insulin, as demonstrated
`in studies performed by trained research staff and by
`patients after receiving appropriate training for
`the
`device.8- 12 However, there are some additional features
`that could further improve these devices for patients.
`Practical aspects of insulin injection pen devices for
`people with diabetes include the ability to hear and feel
`clicks when dialing a dose, easy dialing and delivery,
`ease of performing safety tests, and overall ease of use and
`cartridge replacement in reusable pens. Specific features
`that may be attractive to pen users include insulin pens
`with higher maximum doses to reduce the need for split(cid:173)
`dose injections (most pens have a dose limit of 60 U),
`reduced injection force and dial extension, and improved
`device differentiation, since most of the existing devices
`have little scope for differentiating between the different
`types of insulin to be injected, aside from the product
`label. Both reduced manual dexterity and visual impair(cid:173)
`ments are common in people with diabetes, with up to
`58% of people with diabetes having limited hand joint
`mobility13 and 16 million people with diabetes in the
`United States predicted to have diabetic retinopathy by
`2050.14 In the United States, retinopathy accounts for
`approximately half of all cases of visual impairment
`among people with diabetes older than 50 years.15
`Visual
`impairment in people with diabetes
`is also
`frequently associated with other advanced age-related
`
`conditions, including macular degeneration, glaucoma,
`and cataracts.16
`
`SoloSTAR® is a novel insulin device approved for the
`administration of the long-acting insulin, insulin glargine
`(LANTUS®), or the rapid-acting insulin, insulin glulisine
`(Apidra®), all manufactured by sanofi-aventis for the
`treatment of TlDM or T2DM. SoloSTAR offers a higher
`maximum dose than many of the other insulin pens
`already available (80 U) and offers product differentiation
`by the use of different body colors for insulin glargine
`and insulin glulisine. This should be beneficial for
`patients with TlDM who are likely to use a basal and
`a bolus insulin as well as for the increasing number of
`patients with T2DM who are on basal-bolus regimens.
`Previous studies have demonstrated the dose accuracy,10,11
`low injection force, 8 and patient preference for SoloSTAR
`versus other prefilled insulin pen devices.17 The clinical
`acceptance of SoloSTAR with insulin glargine has been
`examined
`in an observational survey
`in Australia,18
`showing that health care professionals consider it easy to
`educate people with diabetes on the use of the pen and
`consider the pen easy for people with diabetes to use.
`However, the clinical acceptance and patient satisfaction
`with SoloSTAR using insulin glargine and/or insulin
`glulisine have been examined only in Australian patients
`with diabetes,19 not yet in European or North American
`patients. Therefore, in this study, the authors investigated
`acceptance and patient satisfaction with SoloSTAR in
`Canada and 12 European countries.
`
`Methods
`
`Study Objectives
`The objective of this study was to investigate patient
`satisfaction with SoloSTAR in people using insulin glargine
`and/or insulin glulisine in everyday clinical practice.
`
`Study Design
`This was a 6-8-week, multinational (Austria, Canada,
`Denmark, Greece, Hungary, Latvia, The Netherlands,
`Poland, Romania, Slovenia, Slovakia, Sweden, and
`the
`United Kingdom), multicenter (n = 645), open, prospective,
`observational product/device registry study performed
`between January 14, 2008, and April 4, 2009. The study
`was performed in accordance with the principles and
`all subsequent amendments of
`the declaration of
`Helsinki, in compliance with the guidelines for good
`
`J Diabetes Sci Technol Vol 5, Issue 5, September 2011
`
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`
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`Mylan v. Sanofi
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`

`

`A Pan-European and Canadian Prospective Survey to Evaluate Patient Satisfaction
`with the SoloSTAR® Insulin Injection Device in Type 1 and Type 2 Diabetes
`
`Hancu
`
`epidemiological practice and in accordance with the
`STROBE (Strengthening the Reporting of Observational
`Studies
`in Epidemiology) guidelines. 20 All patients
`provided informed consent to participate in the study.
`
`Study Population
`Patients with TlDM or T2DM aged >18 years were enrolled.
`Subjects were eligible if they were current insulin users
`with prior disposable or reusable pen experience, or were
`insulin-nai"ve subjects on oral medications who were
`considered by their health care provider to be candidates
`for starting injectable insulin therapy. Exclusion criteria
`were current addiction to or abuse of alcohol and/or
`drugs, diagnosis of dementia, severe visual or dexterity
`impairment, or a mental condition rendering subjects
`unable to understand the nature, scope, and possible
`consequences of the study. Also excluded from the study
`were subjects who were considered to be uncooperative
`by the investigators and unlikely either to comply with
`the study or to reply honestly to the questionnaire or who
`had a concomitant disease or concomitant medication
`that may have interfered with their ability to participate
`in the study.
`
`Study Protocol
`The study consisted of two visits. At the initial registry
`visit (visit 1), patients were switched to, or started on,
`insulin therapy with LANTUS SoloSTAR for
`insulin
`glargine and/or Apidra SoloSTAR for insulin glulisine.
`For regulatory reasons, patients in Greece and Romania
`could be treated with SoloSTAR for no more than 15 days
`before the study to be considered eligible. All patients
`in Sweden were to be using SoloSTAR before inclusion.
`All treatment decisions were made in accordance with
`local clinical practice, and it was entirely at the physician's
`discretion whether
`to use
`insulin glargine,
`insulin
`glulisine, or both.
`
`At visit 1, patients completed a questionnaire surveying
`their prior experience with insulin pens, if applicable, and
`their demographic and clinical characteristics were also
`assessed. After 6-8 weeks of SoloSTAR use as part of
`everyday clinical practice, patients completed a second
`questionnaire (visit 2) to document their experience and
`determine their acceptance of SoloSTAR. For patients
`who used an insulin pen before inclusion, acceptance
`of SoloSTAR was compared to the pen used before
`the study. In addition, the following information was
`collected: person who gave the insulin injection; use
`of other insulin pen before SoloSTAR; type of insulin
`
`currently used; number of injection devices currently
`used; start of SoloSTAR use the day patient received
`the supply; if patient did not start using SoloSTAR the
`day he or she received it, number of days after; whether
`patient was still using SoloSTAR; if patient was not still
`using SoloSTAR, number of days since he/she stopped;
`number of SoloSTAR pens used; disability or other
`restrictions; frequency of use of a new needle; frequency of
`safety test; brand of needles with SoloSTAR; face-to-face
`training on the use of SoloSTAR; confidence in the use
`of the pen after the training; and number of days to be
`confident in the use of SoloSTAR.
`
`Treatment-emergent adverse events (TEAEs), possibly
`related TEAEs, and serious TEAEs were analyzed.
`Treatment-emergent adverse events are adverse events
`beginning between the first use of the SoloSTAR pen and
`the last use of SoloSTAR pen plus 7 days for SoloSTAR
`with insulin glargine and plus 2 days for SoloSTAR with
`insulin glulisine. For patients who were treated with
`SoloSTAR before inclusion in the study, TEAEs were
`counted from date of inclusion.
`
`Study End Points
`The primary end point was patient evaluation of the
`SoloSTAR pen. The following
`items (answered with
`excellent, good, acceptable, poor, or very poor) were
`described to evaluate the SoloSTAR pen: ease of selecting
`the dose; ease of correcting a misdialed dose; ease of
`reading the insulin dose; ease of feeling and hearing
`dialing clicks; force or effort needed to inject insulin;
`smoothness or gentleness of injection; ease of knowing
`that injection was completed or desired dose was delivered;
`ease of reading how much insulin remained in the
`cartridge; ease of differentiating the LANTUS SoloSTAR
`from the Apidra SoloSTAR, for patients using both;
`ease of learning how to use SoloSTAR; ease of use of
`SoloSTAR in general; overall assessment of SoloSTAR pen;
`plan to continue to use SoloSTAR (yes or no); and whether
`the patient would recommend SoloSTAR (yes or no).
`
`Secondary end points were acceptance of individual pen
`features; insulin daily dose injected; number of daily
`injections; confidence in managing the pen or condition;
`occurrence of pen defects spontaneously reported by
`users; satisfaction with the previous pen, if appropriate,
`and comparison between SoloSTAR and the previous
`pen; and adverse events,
`including hypoglycemia
`(adverse events were recorded and coded using MedDRA
`version 8).
`
`J Diabetes Sci Technol Vol 5, Issue 5, September 2011
`
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`

`A Pan-European and Canadian Prospective Survey to Evaluate Patient Satisfaction
`with the SoloSTAR® Insulin Injection Device in Type 1 and Type 2 Diabetes
`
`Hancu
`
`Statistical Analysis
`There was no formal sample size calculation for this
`observational study; however, the authors planned to
`recruit approximately 6900 patients across 645 centers
`distributed in 13 countries. The primary outcomes were
`evaluated using chi-squared tests for the overall population
`and for subgroups of patients according to age, diabetes
`type, prior history of using insulin and insulin pens, and
`whether the patient performed safety tests. Logistic
`regression was also performed to identify factors predicting
`satisfaction with SoloSTAR. Secondary outcomes and
`adverse events were assessed using appropriate summary
`statistics, with means ± standard deviation (SD) for
`continuous variables and n (%) for categorical variables.
`Factors recorded by questionnaire at visits 1 and 2 were
`
`analyzed by McNemar's test to evaluate change in these
`factors over the course of using the SoloSTAR pen.
`
`Results
`
`Baseline Characteristics
`A total of 6542 patients were enrolled in this registry
`(6528 eligible; 14 excluded owing to missing age or that
`they did not have TlDM or T2DM). Of these, 6364 were
`included in the assessment of patient satisfaction and
`6481 were included in the safety population (Figure 1):
`mean ± SD age of 54.3 ± 14.5 years, 48.7% were male, and
`72.0% had T2DM. Overall, 164 patients were excluded
`from the patient satisfaction population for the following
`reasons: no insulin injections with SoloSTAR (n = 47),
`
`Enrolled
`(n = 6542)
`
`,,
`
`Eligible for study
`(n = 6528)
`
`Included in analysis of
`patient satisfaction
`(n = 6364)
`
`Excluded (n = 14)*
`• Missing age (n = 5)
`• No T1 DM/T2DM (n = 12)
`
`Excluded (n = 164)*
`• No SoloSTAR injection (n = 5)
`• No baseline/follow-up evaluation (n = 82)
`• Questionnaire - 2 questions not
`completed or completed more than 30
`days after last injection (n = 110)
`• SoloSTAR use <7 days (n = 93)
`
`Figure 1. Participant disposition. The safety population (n = 6481) included all eligible patients excluding those who did not inject SoloSTAR
`(n = 47). *Patients may have more than one reason for exclusion.
`
`J Diabetes Sci Technol Vol 5, Issue 5, September 2011
`
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`A Pan-European and Canadian Prospective Survey to Evaluate Patient Satisfaction
`with the SoloSTAR® Insulin Injection Device in Type 1 and Type 2 Diabetes
`
`Hancu
`
`nonparticipation at baseline or follow-up (n = 82), or
`follow-up questionnaire was missing or completed more
`than 30 days after the last injection (n = 110; patients
`were allowed more than one reason for exclusion).
`The characteristics of the eligible patients are shown
`in Table 1.
`
`Prior Insulin Treatment
`Most patients (77.1%) had previously received insulin
`(Table 1), and the majority were using basal or rapid(cid:173)
`acting insulin, with similar proportions of patients using
`analog or human insulins; doses of insulin prior to the
`study are presented in Table 1. The majority of patients
`
`Table 1.
`Baseline Characteristics and Prior Insulin Therapya
`
`Characteristic
`
`N
`
`Age (years)
`
`18-35
`
`35-60
`
`60-70
`
`70-80
`
`>80
`
`Male
`
`Female
`
`Sex
`
`Weight (kg)
`
`Height (cm)
`
`Body mass index (kg/m 2
`)
`
`<25
`
`25-30
`
`T1DM
`
`1817
`
`40.4 ± 13.8
`
`715 (39.4)
`
`939 (51.7)
`
`136 (7.5)
`
`22 (1.2)
`
`5 (0.3)
`
`948 (52.2)
`
`869 (47.8)
`
`73.8 ± 15.2
`
`171.0 ± 9.4
`
`25.2 ± 4.5
`
`1014 (56.2)
`
`T2DM
`
`4664
`
`59.7 ± 10.6
`
`65 (1.4)
`
`2458 (52.7)
`
`1383 (29.7)
`
`656 (14.1)
`
`102 (2.2)
`
`2209 (47.4)
`
`2455 (52.6)
`
`86.8 ± 17.4
`
`168.4 ± 9.0
`
`30.6 ± 5.6
`
`677 (14.7)
`
`Total population
`
`6481
`
`54.3 ± 14.5
`
`780 (12.0)
`
`3397 (52.4)
`
`1519 (23.4)
`
`678 (10.5)
`
`107 (1.7)
`
`3157 (48.7)
`
`3324 (51.3)
`
`83.1 ± 17.8
`
`169.1 ± 9.2
`
`29.1 ± 5.9
`
`1691 (26.3)
`
`2243 (34.9)
`
`?:30
`
`Prior insulin therapy
`
`Yes
`
`Prior analog insulin (U)
`
`Basal insulin
`
`Rapid-acting insulin
`
`Premixed insulin
`
`Prior human insulin (U)
`
`Basal insulin
`
`Rapid-acting insulin
`
`Premixed insulin
`
`Use of an insulin pen before inclusionb
`
`Yes
`
`Prefilled
`
`Reusable
`
`LANTUS SoloSTAR
`
`Apidra SoloSTAR
`
`a Values are mean ± SD or n (%).
`b Only patients using insulin before inclusion.
`
`570 (31.6)
`
`219 (12.1)
`
`1673 (36.2)
`
`2270 (49.1)
`
`2489 (38.8)
`
`1736 (95.5)
`
`3259 (69.9)
`
`4995 (77.1)
`
`26 ± 13 (n = 909)
`
`36 ± 23 (n = 1160)
`
`31 ± 20 (n = 2069)
`
`29 ± 13 (n = 1113)
`
`37 ± 21 (n = 952)
`
`33 ± 17 (n = 2065)
`
`40 ± 21 (n = 79)
`
`53 ± 31 (n = 291)
`
`50 ± 30 (n = 370)
`
`25 ± 13 (n = 671)
`
`30 ± 19 (n = 1412)
`
`29 ± 17 (n = 2083)
`
`29 ± 15 (n = 493)
`
`37 ± 19 (n = 933)
`
`34 ± 18 (n = 1426)
`
`33 ± 16 (n = 93)
`
`47 ± 23 (n = 279)
`
`43 ± 22 (n = 372)
`
`1717 (98.9)
`
`538 (31.0)
`
`1313 (75.6)
`
`337 (19.3)
`
`547 (38.1)
`
`3092 (94.9)
`
`1103 (33.8)
`
`2082 (63.9)
`
`1491 (32.9)
`
`1382 (35.2)
`
`4809 (96.3)
`
`1641 (32.9)
`
`3395 (68.0)
`
`1828 (29.2)
`
`1929 (36.0)
`
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`

`A Pan-European and Canadian Prospective Survey to Evaluate Patient Satisfaction
`with the SoloSTAR® Insulin Injection Device in Type 1 and Type 2 Diabetes
`
`Hancu
`
`who used insulin were using insulin pens, with use of
`reusable pens (68%) predominating over prefilled pens
`(32%). The most commonly used devices were NovoPen® 3
`(Novo Nordisk; 21.6%), HumaPen® Ergo (Eli Lilly; 19.3%),
`FlexPen® (Novo Nordisk; 12.4%), OptiPen Pro® (sanofi(cid:173)
`aventis; 11.7%), and NovoPen® 4 (Novo Nordisk; 9.3%).
`Of the 97.3% (n = 6305) of patients that used SoloSTAR
`with insulin glargine during the study, 29.2% (n = 1828)
`were using SoloSTAR with insulin glargine prior to the
`study. Of the 36% (n = 1929) that used SoloSTAR with
`insulin glulisine during the study, 23.7% (n = 454) were
`using SoloSTAR with insulin glulisine prior to the
`study. Before inclusion, 30.5% (n = 1975) of patients were
`using SoloSTAR with both insulin glargine and insulin
`glulisine, and 27.0% (n = 1753) used SoloSTAR with both
`insulin glargine and insulin glulisine during the study.
`A total of 655 patients (17.6%) were insulin-naive prior to
`inclusion in this study, of which 81 patients were newly
`diagnosed with TlDM and initiated insulin therapy at
`the start of the study.
`
`Insulin Therapy During the Study
`During the study, most patients (97.3%, n = 6305) started
`SoloSTAR with insulin glargine with a mean daily dose
`of 26 ± 17 U [TlDM, n = 1749 (96.3%), 24 ± 12 U; T2DM,
`n = 4556 (97.7%), 27 ± 18 U]. In addition, 36% (n = 1929)
`
`of patients started SoloSTAR with insulin glulisine,
`with a mean daily dose of 31 ± 16 U [TlDM, n = 547
`(38.1%), 29 ± 14 U; T2DM, n = 1382 (35.2%), 32 ± 17 U].
`The median number of insulin glulisine doses per day
`was three (range 1-8 doses).
`
`Evaluation of SoloSTAR
`A total of 3569 patients completed the questionnaire
`documenting prior
`insulin and
`insulin pen use at
`baseline, and 6364 completed the follow-up questionnaire
`documenting their use of SoloSTAR during the study.
`Patients' perceptions of their previous pen (n = 3569)
`and of SoloSTAR (n = 6364) are summarized in Figure 2.
`Previously used pen devices were generally perceived as
`excellent or good by similar proportions of participants
`for each of the factors recorded. However, the SoloSTAR
`pen was perceived extremely positively, as shown by
`the majority of patients who rated SoloSTAR as excellent
`across all eight factors. In particular, the ease of selecting
`the dose (prior pen, 38.1%; SoloSTAR, 76.3%) and the ease
`of correcting a misdialed dose (prior pen, 32%; SoloSTAR,
`73.4%) were rated very highly for SoloSTAR by the total
`study population, compared with those documenting prior
`pen use. Less than 2% of patients rated SoloSTAR as poor
`or very poor for all eight factors, while 1.5-10.3% of the
`patients rated their previous device as poor or very poor.
`
`100
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`
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`
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`
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`dialing clicks
`
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`20
`10
`0
`
`"
`<O
`
`(0
`
`..
`c
`~
`
`w
`
`0
`0
`
`..,
`"
`
`..
`
`:;;
`!!
`Q.
`~
`
`<(
`
`,-..
`<Xi
`(0
`
`;
`0
`a..
`
`~
`0
`0
`Q.
`~
`>
`
`..
`
`c
`.!!
`~
`w
`
`0
`0
`
`..,
`"
`
`..
`~
`~
`
`Q.
`
`<(
`
`100
`
`..... 90
`.. 60
`e...
`~ 80
`70
`Ill
`C 50
`(I)
`:;:i 40
`ca 30
`a. 20
`
`10
`0
`
`;
`0
`a..
`
`'"-: "'
`"' ci
`
`~
`0
`0
`Q.
`~
`>
`
`..
`
`Force/effort to inject
`
`Smoothness/gentleness of injection
`
`co
`c.j
`(0
`
`..
`c
`~
`
`w
`
`0
`0
`
`..,
`"
`
`;
`0
`a..
`
`Q.
`
`"! (0
`<") ci
`
`~
`0
`0
`Q.
`~
`>
`
`..
`
`..
`~
`~
`<(
`Ease of knowing that the injection is
`complete/desired dose is delivered
`
`a,
`ci
`(0
`
`c
`.!!
`ii
`><
`w
`
`0
`0
`
`..,
`"
`
`..
`~
`Q.
`~
`:.
`
`;
`0
`a..
`
`~
`0
`0
`Q.
`~
`>
`
`..
`
`Ease of reading how much insulin
`is remaining in the cartridge
`
`Figure 2. Patient acceptance of SoloSTAR and the acceptance of a previously used device. Open bars, previous device (n = 3569) reported at
`visit l; closed bars, SoloSTAR (n = 6364, reported at follow-up visit).
`
`J Diabetes Sci Technol Vol 5, Issue 5, September 2011
`
`1229
`
`www. iournalofdst. orq
`
`Sanofi Exhibit 2129.006
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`A Pan-European and Canadian Prospective Survey to Evaluate Patient Satisfaction
`with the SoloSTAR® Insulin Injection Device in Type 1 and Type 2 Diabetes
`
`Hancu
`
`Table 2.
`Responses to the Follow-Up Questionnaire: Patient
`Satisfaction Population
`
`The final follow-up questionnaire also asked patients to
`directly compare SoloSTAR with their previously used
`pen. In total, 55.5% (2588/4660) rated SoloSTAR as much
`easier to use, 32.9 (1531) as easier, 9.9% (460) as the same,
`and 1.7% (79) as more difficult or much more difficult to
`use compared with the previously used device. In terms
`of ease of injecting the insulin dose, 54.7% (2538/4644)
`rated SoloSTAR as much easier, 29.8% (1386) as easier,
`13.3% (618) as the same, and 2.2% (102) as more difficult
`or much more difficult to use. Of 1703 patients who
`compared ease of differentiation between SoloSTAR with
`insulin glargine and SoloSTAR with insulin glulisine,
`72.7% of patients rated this factor as excellent, 22.2%
`as good, 3.8% as acceptable, 0.9% as poor, and 0.4% as
`very poor.
`
`Overall, 87.7% (4092/4668) of patients stated that they
`preferred SoloSTAR to their previous pen, while 3.4% (160)
`preferred their previous pen and 8.9% (414) had no
`preference. The majority of patients were planning to
`continue to use SoloSTAR (98.2%; n = 6059) and would
`recommend SoloSTAR (98.8%; n = 6078). Additional data
`collected from
`the final
`follow-up questionnaire
`is
`reported in Table 2.
`
`Ease of Learning and Ease of Use
`In the population of patients who were included in the
`assessment of patient satisfaction (n = 6364), the ease
`of learning and ease of use of SoloSTAR was rated as
`excellent (80.7% and 78.9%, respectively) or good (17.6%
`and 19%, respectively; Figure 3).
`
`Overall Assessment of SoloSTAR
`In the overall assessment of SoloSTAR (n = 6364), the
`device was rated as excellent by 75.8% of patients, good
`by 21.4%, acceptable by 2.0%, and poor or very poor by
`0.7% (Figure 4). Most patients planned to continue using
`SoloSTAR (98.2%) and would recommend SoloSTAR to
`
`Patient filled in questionnaire 2
`Yes
`
`Person who gave the insulin injection
`Self
`Parent
`Spouse
`Nurse/carer
`Other
`Missing (n)
`
`Use of other insulin pen before SoloSTAR
`One other
`Two others
`Three or more
`Never
`Missing (n)
`
`Type of insulin currently used
`Insulin glargine only
`Insulin glulisine only
`Insulin glargine and apidra
`Insulin glargine + one other insulin
`Insulin glargine + two other insulins
`Insulin glargine + three other insulins
`Insulin glulisine + one other insulin
`Insulin glulisine + two other insulins
`Insulin glulisin + three other insulins
`Missing (n)
`
`Number of injection devices currently used
`SolorSTAR only
`SolorSTAR + one other
`SolorSTAR + two others
`Missing (n)
`
`Start of SoloSTAR use the day patient
`received the supply
`Yes
`No, 1 day later
`No, 2 days later No, 3 days later
`No, 4 days later
`Yes/no, 2 days later
`Yes/no 3 days later
`Missing (n)
`
`Patient was still using SoloSTAR
`Yes
`No, stopped 1-6 days ago
`No, stopped 1-2 weeks ago
`No, stopped 3-4 weeks ago
`No, stopped 5-6 weeks ago
`Missing (n)
`
`~
`
`6
`
`~
`0
`Q.
`
`~
`>
`
`Number of SoloSTAR pens used
`1-7 pens
`8-14 pens
`15-21 pens
`>21 pens
`Missing (n)
`Mean number of pens used (SD)
`Median number of pens used (Q1, Q3)
`
`n!N (%)
`(N = 6364)
`
`6364/6364 (100.0)
`
`6188/6355 (97.4)
`11/6355 (0.2)
`73/6355 (1.1)
`39/6355 (0.6)
`44/6355 (0.7)
`9
`
`2463/6330 (38.9)
`1804/6330 (28.5)
`442/6330 (7.0)
`1621/6330 (25.6)
`34
`
`2036/6228 (32.7)
`39/6228 (0.6)
`2157/6228 (34.6)
`1870/6228 (30.0)
`26/6228 (0.4)
`15/6228 (0.2)
`83/6228 (1.3)
`1/6228 (0.0)
`1/6228 (0.0)
`136
`
`4110/6310 (65.1)
`2180/6310 (34.5)
`20/6310 (0.3)
`54
`
`5018/6333 (79.2)
`683/6333 (10.8)
`199/6333 (3.1)
`113/6333 (1.8)
`318/6333 (5.0)
`1/6333 (0.0)
`1/6333 (0.0)
`31
`
`6245/6291 (99.3)
`22/6291 (0.3)
`10/6291 (0.2)
`9/6291 (0.1)
`5/6291 (0.1)
`73
`
`4070/5941 (68.5)
`1362/5941 (22.9)
`352/5941 (5.9)
`157/5941 (2.6)
`423
`7 (6.0)
`5 (3, 9)
`
`.. C
`
`100
`90
`~
`80
`~ 70
`60
`II)
`50
`(I)
`40
`.:; 30
`ca
`Q.
`20
`10
`0
`
`~
`
`g
`
`1:
`
`..
`!
`
`w
`
`"'
`..:
`
`..
`"
`
`0
`0
`
`N
`
`ii
`
`"'
`re
`
`1:
`•
`~
`
`w
`
`,.,
`6
`
`~
`0
`Q.
`i!:'
`•
`>
`
`6
`
`0
`0
`
`. ~
`i ..
`..
`
`Ease of learning how to use SoloSTAR
`
`"'
`
`-
`..
`
`,.,
`6
`
`~
`0
`0
`
`0
`0
`
`ii
`
`..
`" I ..
`
`C
`Ease of use of SoloSTAR
`
`Figure 3. Acceptance of SoloSTAR in terms of use and ease of training.
`
`(continued) ➔
`
`J Diabetes Sci Technol Vol 5, Issue 5, September 2011
`
`1230
`
`www. iournalofdst. orq
`
`Sanofi Exhibit 2129.007
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`A Pan-European and Canadian Prospective Survey to Evaluate Patient Satisfaction
`with the SoloSTAR® Insulin Injection Device in Type 1 and Type 2 Diabetes
`
`Hancu
`
`Table 2. Continued
`
`Disability or other restrictions
`None
`Missing (n)
`If patient has disability or other restrictions
`Poor eyesight not corrected by glasses!
`contact lenses
`Mild
`Moderate
`Severe
`Missing (n)
`Manual dexterity problems
`Mild
`Moderate
`Severe
`Missing (n)
`Other type of disability
`Mild
`Moderate
`Severe
`Missing (n)
`
`Frequency of using a new needle
`Before every injection
`Every second day
`Every third day
`Between 4-5 days
`Between 6-7 days
`>7 days
`Missing (n)
`
`Frequency of safety test
`Before every injection
`Every second day
`Once a week
`With each new pen
`Only when there are air bubbles in the
`reservoir
`Never
`Missing (n)
`
`Brand of needle used with SoloSTARa
`BD
`Novo Nordisk
`Ypsomed
`Braun
`Other
`BO/Novo Nordisk
`BD/Ypsomed
`BO/Braun n!N
`BO/other n!N
`Novo Nordisk/Ypsomed
`Novo Nordisk/other
`Ypsomed/Braun
`Braun/other
`BO/Novo Nordisk/Ypsomed
`BO/Novo Nordisk/Braun
`BO/Novo Nordisk/other
`BD/Ypsomed/Braun
`BD/Ypsomed/other
`BO/Novo Nordisk/Ypsomed/Braun
`Missing
`
`Face-to-face training on the use of
`SoloSTAR
`Yes
`No
`Missing (n)
`
`n!N (%)
`(N = 6364)
`
`5151/5151 (100.0)
`1213
`
`447/828 (54.0)
`317/828 (38.3)
`64/828 (7.7)
`482
`
`379/731 (51.8)
`283/731 (38.7)
`69/731 (9.4)
`482
`
`153/322 (47.5)
`126/322 (39.1)
`43/322 (13.4)
`891
`
`1488/6327 (23.5)
`976/6327 (15.4)
`1061/6327 (16.8)
`1059/6327 (16.7)
`822/6327 (13.0)
`921/6327 (14.6)
`37
`
`2337/6283 (37.2)
`686/6283 (10.9)
`893/6283 (14.2)
`1843/6283 (29.3)
`232/6283 (3.7)
`
`292/6283 (4.6)
`81
`
`3224/6201 (52.0)
`1713/6201 (27.6)
`576/6201 (9.3)
`66/6201 (1.1)
`484/6201 (7.8)
`77/6201 (1.2)
`18/6201 (0.3)
`2/6201 (0.0)
`9/6201 (0.1)
`3/6201 (0.0)
`6/6201 (0.1)
`2/6201 (0.0)
`2/6201 (0.0)
`9/6201 (0.1)
`1/6201 (0.0)
`4/6201 (0.1)
`3/6201 (0.0)
`1/6201 (0.0)
`1/6201 (0.0)
`163
`
`6101/6344 (96.2)
`243/6344 (3.8)
`20
`
`Confidence in the use of the pen after the
`training
`Yes
`No
`Missing
`
`Number of days to be confident in the use
`of SoloSTAR
`O days
`1 day
`2 days
`3 days
`4-8 days
`>8 days
`Missing
`Mean number of days (SD)
`Median (Q1, Q3)
`
`a BD: Becton, Dickinson & Co.
`
`100
`
`90
`
`5905/6228 (94.8)
`323/6228 (5.2)
`136
`
`767/6098 (12.6)
`3515/6098 (57.6)
`826/6098 (13.5)
`436/6098 (7.1)
`446/6098 (7.3)
`108/6098 (1.8)
`266
`2 (2.3)
`1 (1,2)
`
`00
`
`~
`
`80
`~ 70
`e...
`60
`Ill
`
`.. C
`
`50
`
`(I)
`~ 40
`ca
`a. 30
`20
`
`10
`
`0
`
`0
`<'i
`
`Excellent
`
`Good
`
`Acceptable
`
`Figure 4. Overall assessment of SoloSTAR.
`
`~
`
`ci
`
`Poor
`
`Very poor
`
`others (98.8%). The overall assessment of SoloSTAR was
`comparable between age groups, type of diabetes, and
`prior use of insulin in patients with T2DM.
`
`Safety
`A total of 353 TEAEs were reported by 192 patients,
`of which 238 events in 105 patients were episodes of
`hypoglycemia (Table 3). Ten events corresponding to
`injection-site conditions were reported by 10 patients,
`including four episodes of injection site pain, three
`of injection site discomfort, and one each of cyst and
`injection site erythema. Thirty patients experienced a
`serious TEAE, of which three were considered by the
`investigator to be possibly related to insulin glargine
`treatment. One patient experienced moderate hypo(cid:173)
`glycemia due to an overdose of insulin glargine and was
`involved in a car accident. This occurred 4 days after
`the study start, and the patient recovered after 1 day.
`One patient experienced severe hypoglycemia due to
`an overdose of insulin glargine approximately 1 month
`after the study start. Recovery occurred on the same
`day. One patient experienced unconsciousness due to
`severe hypoglycemia following
`insulin glargine use.
`This occurred approximately 1 month after study start,
`and the patient recovered the same day.
`
`J Diabetes Sci Technol Vol 5, Issue 5, September 2011
`
`1231
`
`www. iournalofdst. orq
`
`Sanofi Exhibit 2129.008
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`A Pan-European and Canadian Prospective Survey to Evaluate Patient Satisfaction
`with the SoloSTAR® Insulin Injection Device in Type 1 and Type 2 Diabetes
`
`Hancu
`
`Table 3.
`Treatment-Emergent Adverse Events
`
`Insulin glargine or insulin
`glargine plus insulin glulisine
`(n = 6305)
`
`Events
`
`352
`
`250
`
`21
`
`20
`
`9
`
`Patients
`
`n
`
`191
`
`116
`
`20
`
`19
`
`9
`
`%
`
`3.03
`
`1.84
`
`0.32
`
`0.3
`
`0.14
`
`Insulin glulisine (n = 176)
`
`All patients (n = 6481)
`
`Events
`
`1
`
`1
`
`Patients
`
`n
`
`1
`
`1
`
`%
`
`0.57
`
`0.57
`
`Events
`
`353
`
`250
`
`22
`
`20
`