CLINICAL THERAPEUTICSWOL. 20, NO. 3, 1998
`
`CLINICAL THERAPEUTICSVVOL. 20, NO. 3, 1998 Assessment by Patients with Diabetes Mellitus of Two Insulin Pen Delivery Systems Versus a Vial and Syringe
`
`Assessment by Patients with Diabetes Mellitus of Two
`Insulin Pen Delivery Systems Versus a Vial and Syringe
`
`Marilyn R. Graff, RN, CDE,’ and Mark A. McClunahan, MD2
`Marilyn R. Graff, RN, CDE,1 and Mark A. McClanahan, MD2
`1Diabetes Care Team, Longmont Clinic, Longmont, Colorado, and 2Diabetes and
`Thyroid Associates, Fredericksburg, Virginia
`
`‘Diabetes Care Team, Longmont Clinic, Longmont, Colorado, and 2Diabetes and Thyroid Associates, Fredericksburg, Virginia ABSTRACT Two multicenter surveys were conducted in a total of 13 10 insulin users over a 3-week period. The first survey, in which 803 patients participated, assessed the ef- fects of using the Novolin Prefilled in- sulin delivery system on lifestyle; com- pliance with insulin, diet, and exercise regimens; and feelings of well-being com- pared with the traditional insulin vial and syringe. The second survey, in which 507 patients participated, assessed attitudes and perceptions of the NovoPen 1.5 in- sulin delivery system compared with the traditional insulin vial and syringe. Both delivery systems are dial-a-dose insulin pens containing a single-use NovoFine 30 insulin needle and are designed to be portable and discreet. Patients using tbe Novolin Prefilled delivery system com- pleted a three-part questionnaire (two parts at the initial survey visit and the third at the end of 3 weeks); those using the NovoPen 1.5 completed a question- naire at the end of 3 weeks. Seven hun- dred twenty-nine (92%) of 793 patients in the Novolin Prefilled group and 482 (98%) of 492 patients in the NovoPen 1.5 group reported that it was easy to use these delivery systems; 672 (85%) of 791 pa- tients reported that they missed no injec- tions while using the Novolin Prefilled system, compared with 566 (72%) of 789 patients using the vial and syringe. With the NovoPen 1.5, 333 (73%) of 456 pa- tients said that the dosing mechanism was more accurate, and 351 (77%) of 456 pa- tients found it easier to comply with their insulin regimen. In both groups, patients reported a strong desire to continue using the insulin pens and a willingness to rec- ommend their use to someone else. Be- cause patients were more physically and psychologically comfortable injecting in- sulin with the Novolin Prefilled or NovoPen 1.5 system than with an insulin syringe, their overall attitude toward in- sulin therapy improved, as did their con- fidence about managing their disease. An improved attitude toward insulin therapy might be expected to lead to better accep- tance of and compliance with an insulin regimen. Key words: diabetes, insulin, quality of life, compliance, insulin deliv- ery systems, insulin pens. 486
`
`Two multicenter surveys were conducted
`in a total of 1310 insulin users over a
`3-week period. The first survey, in which
`803 patients participated, assessed the ef-
`fects of using the Novolin Prefilled in-
`sulin delivery system on lifestyle; com-
`pliance with insulin, diet, and exercise
`regimens; and feelings of well-being com-
`pared with the traditional insulin vial and
`syringe. The second survey, in which 507
`patients participated, assessed attitudes
`and perceptions of the NovoPen 1.5 in-
`sulin delivery system compared with the
`traditional insulin vial and syringe. Both
`delivery systems are dial-a-dose insulin
`pens containing a single-use NovoFine 30
`insulin needle and are designed to be
`portable and discreet. Patients using the
`Novolin Prefilled delivery system com-
`pleted a three-part questionnaire (two
`parts at the initial survey visit and the
`third at the end of 3 weeks); those using
`the NovoPen 1.5 completed a question-
`naire at the end of 3 weeks. Seven hun-
`dred twenty-nine (92%) of 793 patients in
`the Novolin Prefilled group and 482
`
`ABSTRACT
`
`(98%) of 492 patients in the NovoPen 1.5
`group reported that it was easy to use these
`delivery systems; 672 (85%) of 791 pa-
`tients reported that they missed no injec-
`tions while using the Novolin Prefilled
`system, compared with 566 (72%) of 789
`patients using the vial and syringe. With
`the NovoPen 1.5, 333 (73%) of 456 pa-
`tients said that the dosing mechanism was
`more accurate, and 351 (77%) of 456 pa-
`tients found it easier to comply with their
`insulin regimen. In both groups, patients
`reported a strong desire to continue using
`the insulin pens and a willingness to rec-
`ommend their use to someone else. Be-
`cause patients were more physically and
`psychologically comfortable injecting in-
`sulin with the Novolin Prefilled or
`NovoPen 1.5 system than with an insulin
`syringe, their overall attitude toward in-
`sulin therapy improved, as did their con-
`fidence about managing their disease. An
`improved attitude toward insulin therapy
`might be expected to lead to better accep-
`tance of and compliance with an insulin
`regimen. Key words: diabetes, insulin,
`quality of life, compliance, insulin deliv-
`ery systems, insulin pens.
`
`486
`
`0149-2918/98/$19.00
`0149-2918/98/$19.00
`
`Mylan Ex.1047
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`M.R. GRAFF AND M.A. McCLANAHAN
`M.R. GRAFF AND M.A. McCLANAHAN
`
`INTRODUCTION
`
`are alternative insulin delivery systems
`that allow patients to take insulin without
`having to use a traditional insulin vial and
`syringe. Each pen uses the NovoFine*
`30 insulin needle, which is disposed of af-
`ter one injection. The NovoPen 1.5 uses
`Novolin PenFill®*, a 1.5-mL cartridge
`(150 U) of human insulin (recombinant
`DNA origin) in an NPH, regular, or 70/30
`formulation. By dialing a dose, patients
`can select delivery of up to 40 U per dose
`in 1-U increments. The Novolin Prefilled
`disposable insulin pen contains 150 U of
`human insulin and allows delivery of up
`to 58 U per dose in 2-U increments. A
`4-week clinical stud? with the Novolin
`Prefilled system showed significant patient
`acceptance among 64 insulin users, 98%
`of whom found the pen convenient and
`easy to use. The present study employed
`two large, multicenter surveys to assess
`users' acceptance of the Novolin Prefilled
`and NovoPen 1.5 insulin delivery systems.
`
`*NovoPen®, Novolin R Prefilled"', Novolin N Pre-
`filled'', Novolin 70/30 Prefilled"", NovoFine®,
`Novolin®, and PenFill® are trademarks of Novo
`Nordisk A/S, Copenhagen, Denmark.
`
`Diabetes has an enormous impact on pa-
`tients' lives, requiring regular glucose
`monitoring, modifications in diet and
`lifestyle, frequent visits to physicians and
`diabetes educators, daily administration
`of medication, and, for many, self-inject-
`ing with insulin. The health-care profes-
`sional plays an important role in helping
`patients achieve the best quality of life
`possible, which means that professionals
`and patients both must do more than fo-
`cus on stabilizing blood glucose levels.
`Equally important are education about di-
`abetes and its treatment, active participa-
`tion in instituting diet and lifestyle
`changes, and fostering a positive attitude
`about patients' ability to comply with
`medication regimens.'
`A significant number of patients resist
`taking insulin because of its inconve-
`nience or imagined pain, the stigma of us-
`ing a vial and syringe, or fear of self-
`injection.1-3 This may be especially true
`for patients with type 2 diabetes, many of
`whom had at one time been able to con-
`trol their diabetes with diet and exercise,
`oral medication, or both. These patients
`may view the need for insulin as a sign
`that their disease is worsening or that they
`have failed to take care of themselves
`properly.2 Health professionals should be
`aware of these feelings and be able to rec-
`ommend appropriate self-care options for
`the patient's consideration.
`The Novolin Prefilled®* system (a dis-
`posable pen) and NovoPen®* 1.5 (a
`durable pen with a replaceable cartridge)
`
`INTRODUCTION Diabetes has an enormous impact on pa- tients’ lives, requiring regular glucose monitoring, modifications in diet and lifestyle, frequent visits to physicians and diabetes educators, daily administration of medication, and, for many, self-inject- ing with insulin. The health-care profes- sional plays an important role in helping patients achieve the best quality of life possible, which means that professionals and patients both must do more than fo- cus on stabilizing blood glucose levels. Equally important are education about di- abetes and its treatment, active participa- tion in instituting diet and lifestyle changes, and fostering a positive attitude about patients’ ability to comply with medication regimens.’ A significant number of patients resist taking insulin because of its inconve- nience or imagined pain, the stigma of us- ing a vial and syringe, or fear of self- injection. 1-3 This may be especially true for patients with type 2 diabetes, many of whom had at one time been able to con- trol their diabetes with diet and exercise, oral medication, or both. These patients may view the need for insulin as a sign that their disease is worsening or that they have failed to take care of themselves properly.* Health professionals should be aware of these feelings and be able to rec- ommend appropriate self-care options for the patient’s consideration. The Novolin Prefilled@* system (a dis- posable pen) and NovoPen@‘* 1.5 (a durable pen with a replaceable cartridge) *NovoPen@, Novolin R Prebilled”, Novolin N Pre- filled”, Novolin 70/30 Prefilled”, NovoFine@, Novolin@, and PenFilla are trademarks of Novo Nordisk A/S, Copenhagen, Denmark. are alternative insulin delivery systems that allow patients to take insulin without having to use a traditional insulin vial and syringe. Each pen uses the NovoFine@‘* 30 insulin needle, which is disposed of af- ter one injection. The NovoPen 1.5 uses Novolin PenFill@*, a 1.5mL cartridge (150 U) of human insulin (recombinant DNA origin) in an NPH, regular, or 70/30 formulation. By dialing a dose, patients can select delivery of up to 40 U per dose in 1-U increments. The Novolin Pretilled disposable insulin pen contains 150 U of human insulin and allows delivery of up to 58 U per dose in 2-U increments. A 4-week clinical studf with the Novolin Prefilled system showed significant patient acceptance among 64 insulin users, 98% of whom found the pen convenient and easy to use. The present study employed two large, multicenter surveys to assess users’ acceptance of the Novolin Prefilled and NovoPen 1.5 insulin delivery systems. PATIENTS AND METHODS Patients Centers for the two study surveys were selected on the basis of geographic con- siderations and willingness and ability to carry out the survey. The first survey, which included 803 insulin users in 24 centers across the United States, evalu- ated the Novolin Prebilled pen using the following variables: (1) patients’ partici- pation in normal daily activities and so- cial activities compared with their partic- ipation while using a traditional vial and syringe; (2) patients’ compliance with in- sulin, diet, and exercise regimens; and (3) patients’ overall sense of well-being. The second survey, which included 507 insulin users in 64 centers, assessed the 487
`
`PATIENTS AND METHODS
`
`Patients
`
`Centers for the two study surveys were
`selected on the basis of geographic con-
`siderations and willingness and ability to
`carry out the survey. The first survey,
`which included 803 insulin users in 24
`centers across the United States, evalu-
`ated the Novolin Prefilled pen using the
`following variables: (1) patients' partici-
`pation in normal daily activities and so-
`cial activities compared with their partic-
`ipation while using a traditional vial and
`syringe; (2) patients' compliance with in-
`sulin, diet, and exercise regimens; and
`(3) patients' overall sense of well-being.
`The second survey, which included 507
`insulin users in 64 centers, assessed the
`
`487
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`Mylan Ex.1047
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`CLINICAL THERAPEUTICS®
`
`history; the second part contained 18 ques-
`tions about patients' current treatment reg-
`imen with insulin vial and syringe. The lat-
`ter part included questions on the effects
`on patients' lifestyle of using the traditional
`vial and syringe and on their feelings about
`using this delivery system.
`Patients completed the third part of the
`questionnaire at the physician's office after
`they had used the disposable insulin pen
`for 3 weeks. This contained 26 questions
`comparing compliance and control, effects
`on lifestyle, and opinions and perceptions
`while using the new delivery system with
`experiences while using the vial and sy-
`ringe. Each question in the second part of
`the questionnaire was repeated in the third
`part to allow comparison of patients' expe-
`riences with the insulin vial and syringe
`and the Novolin Prefilled insulin pen.
`Patients in the second survey (NovoPen
`1.5 vs traditional vial and syringe) com-
`pleted a questionnaire containing 25 ques-
`tions about their history and experience
`with insulin and their attitudes and opin-
`ions about the NovoPen 1.5 compared
`with the vial and syringe after using the
`insulin pen for 3 weeks.
`The two surveys contained questions
`that had been used in a previous study' as
`well as questions based on the input of di-
`abetes professionals practicing in a variety
`of settings throughout the United States.
`The data were tabulated by Distinctive
`Marketing, Inc. (Montclair, New Jersey).
`No data were collected retrospectively. Not
`all patients answered all questions.
`
`effect of the NovoPen 1.5 on patients' at-
`titudes about taking insulin, improving
`compliance, and perceiving their comfort.
`Patients were eligible to participate in
`either survey if they had type 1 or type 2
`diabetes; could administer insulin, as as-
`sessed by a health-care professional; could
`read and understand English; and could
`follow printed instructions. On considera-
`tion by the relevant institutional review
`boards, it was determined that approval
`was not required because participation in
`these surveys involved no risk to the sub-
`jects. A health-care professional asked the
`patient if he or she wanted to participate,
`and the patient agreed or refused. Patients
`who chose to participate did not have to
`pay for the insulin delivery system.
`Patients in both groups were given the
`insulin pen delivery system by a research
`coordinator (a physician, nurse, or other di-
`abetes educator), who recorded the patient's
`name and assigned the patient an identifi-
`cation number. During the initial site visit,
`which was a routine medical visit at a physi-
`cian's office, patients were instructed in the
`proper use of the insulin pen, according to
`the approved product labeling. Each patient
`was given sufficient supplies to last 3
`weeks, and arrangements were made for
`their completion of the survey. All patients
`were informed that the surveys were sup-
`ported by Novo Nordisk Pharmaceuticals
`Inc. (Princeton, New Jersey) and that the
`research sites would receive an honorarium
`for participating. Investigators received an
`honorarium but were not paid for enrolling
`patients or prescribing the delivery systems.
`Patients in the first survey (Novolin Pre-
`filled insulin pen vs traditional vial and sy-
`ringe) completed the first two parts of a
`three-part questionnaire during the initial
`site visit. The first part contained 7 general
`questions about demographics and diabetes
`
`CLINICAL THERAF’EUTICS” effect of the NovoPen 1.5 on patients’ at- titudes about taking insulin, improving compliance, and perceiving their comfort. Patients were eligible to participate in either survey if they had type 1 or type 2 diabetes; could administer insulin, as as- sessed by a health-care professional; could read and understand English; and could follow printed instructions. On considera- tion by the relevant institutional review boards, it was determined that approval was not required because participation in these surveys involved no risk to the sub- jects. A health-care professional asked the patient if he or she wanted to participate, and the patient agreed or refused. Patients who chose to participate did not have to pay for the insulin delivery system. Patients in both groups were given the insulin pen delivery system by a research coordinator (a physician, nurse, or other di- abetes educator), who recorded the patient’s name and assigned the patient an identifi- cation number. During the initial site visit, which was a routine medical visit at a physi- cian’s office, patients were instructed in the proper use of the insulin pen, according to the approved product labeling. Each patient was given sufficient supplies to last 3 weeks, and arrangements were made for their completion of the survey. All patients were informed that the surveys were sup- ported by Novo Nordisk Pharmaceuticals Inc. (Princeton, New Jersey) and that the research sites would receive an honorarium for participating. Investigators received an honorarium but were not paid for enrolling patients or prescribing the delivery systems. Patients in the first survey (Novolin Pre- filled insulin pen vs traditional vial and sy- ringe) completed the first two parts of a three-part questionnaire during the initial site visit. The first part contained 7 general questions about demographics and diabetes history; the second part contained 18 ques- tions about patients’ current treatment reg- imen with insulin vial and syringe. The lat- ter part included questions on the effects on patients’ lifestyle of using the traditional vial and syringe and on their feelings about using this delivery system. Patients completed the third part of the questionnaire at the physician’s office after they had used the disposable insulin pen for 3 weeks. This contained 26 questions comparing compliance and control, effects on lifestyle, and opinions and perceptions while using the new delivery system with experiences while using the vial and sy- ringe. Each question in the second part of the questionnaire was repeated in the third part to allow comparison of patients’ expe- riences with the insulin vial and syringe and the Novolin Prefilled insulin pen. Patients in the second survey (NovoPen 1.5 vs traditional vial and syringe) com- pleted a questionnaire containing 25 ques- tions about their history and experience with insulin and their attitudes and opin- ions about the NovoPen 1.5 compared with the vial and syringe after using the insulin pen for 3 weeks. The two surveys contained questions that had been used in a previous study4 as well as questions based on the input of di- abetes professionals practicing in a variety of settings throughout the United States. The data were tabulated by Distinctive Marketing, Inc. (Montclair, New Jersey). No data were collected retrospectively. Not all patients answered all questions. RESULTS Demographic Characteristics More extensive information was ob- tained on the group using the Novolin Pre- 488
`
`RESULTS
`
`Demographic Characteristics
`
`More extensive information was ob-
`tained on the group using the Novolin Pre-
`
`488
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`M.R. GRAFF AND M.A. McCLANAHAN
`
`filled delivery system (Table I) than on
`the group using the NovoPen 1.5 (Table
`II). Adverse event data were not collected.
`A wide range of insulin-using patients
`participated in the Novolin Prefilled sur-
`vey. Four hundred sixty-four (58%) of the
`
`803 patients were 36 to 65 years of age,
`190 (24%) were 66 years of age, and 149
`(19%) were 5_35 years of age. Two hundred
`sixty (32%) of 801 participants had been
`taking insulin for 1 to 5 years; 355 (44%)
`of 801 had been taking insulin for >5 years.
`
`Table I. Demographic characteristics of participants in the Novolin Prefilled®` insulin
`delivery system survey (N = 803, but not all patients answered all questions).
`
`Variable
`
`No. (%) of Patients
`
`M.R. GRAPP AND M.A. McCLANAHAN filled delivery system (Table I) than on 803 patients were 36 to 65 years of age, the group using the NovoPen 1.5 (Table 190 (24%) were 266 years of age, and 149 II). Adverse event data were not collected. (19%) were 135 years of age. Two hundred A wide range of insulin-using patients sixty (32%) of 801 participants had been participated in the Novolin Prefilled sur- taking insulin for 1 to 5 years; 355 (44%) vey. Four hundred sixty-four (58%) of the of 801 had been taking insulin for >5 years. Table I. Demographic characteristics of participants in the Novolin Prebilled@* insulin delivery system survey (N = 803, but not all patients answered all questions). Variable No. (%) of Patients Age (Y) 13s 3655 566s 266 Type of diabetes Type 1 Type 2 Not certain Length of time receiving insulin (y) <l 1-s >S Type of human insulin used 70130 NPH NPH + regular NPH + regular + 70/30 NPH + 70/30 Regular Regular + 70/30 Other Brand of insulin used Humulin@t Novolin Novolin + Humulin Not certain Current insulin regimen QD BID 2TID 149/803 (19) 299/803 (37) 1651803 (21) 190/803 (24) 2X/786 (32) 453/786 (58) 81/786 (10) 186/801 (23) 260/801 (32) 355/801 (44) 295l779 (38) 141/779 (18) 227l779 (29) 26l779 (3) 81779 (1) 19/779 (2) 12/779 (2) 51/779 (7) 4131763 (54) 298l763 (39) 261763 (3) 26l763 (3) 105/745 (14) 431/745 (58) 209i745 (28) *Trademark of Novo Nordisk A/S, Copenhagen, Denmark. ‘Trademark of Eli Lilly and Company, Indianapolis, Indiana. 489
`
`Age (y)
`<35
`36-55
`56-65
`>66
`Type of diabetes
`Type 1
`Type 2
`Not certain
`Length of time receiving insulin (y)
`<1
`1-5
`>5
`Type of human insulin used
`70/30
`NPH
`NPH + regular
`NPH + regular + 70/30
`NPH + 70/30
`Regular
`Regular + 70/30
`Other
`Brand of insulin used
`Humulin®t
`Novolin
`Novolin + Humulin
`Not certain
`Current insulin regimen
`QD
`BID
`
`149/803 (19)
`299/803 (37)
`165/803 (21)
`190/803 (24)
`
`252/786 (32)
`453/786 (58)
`81/786 (10)
`
`186/801 (23)
`260/801 (32)
`355/801 (44)
`
`295/779 (38)
`141/779 (18)
`227/779 (29)
`26/779 (3)
`8/779 (1)
`19/779 (2)
`12/779 (2)
`51/779 (7)
`
`413/763 (54)
`298/763 (39)
`26/763 (3)
`26/763 (3)
`
`105/745 (14)
`431/745 (58)
`209/745 (28)
`
`"Trademark of Novo Nordisk A/S, Copenhagen, Denmark.
`tTrademark of Eli Lilly and Company, Indianapolis, Indiana.
`
`489
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`CLINICAL THERAPEUTICS®
`
`Table II. Demographic characteristics of participants in the NovoPen® 1.5* insulin delivery
`system survey (N = 507, but not all patients answered all questions).
`
`Variable
`
`No. (%) of Patients
`
`Length of time receiving insulin (y)t
`<1
`1-3
`4-9
`
`Type of human insulin used
`70/30
`NPH
`NPH + regular
`Regular
`Regular + other
`Other
`Brand of insulin used
`Humulin(44
`Novolin
`New to insulin
`Other
`Current insulin regimen
`QD
`QD
`BID
`TID
`
`'Trademark of Novo Nordisk A/S, Copenhagen, Denmark.
`tMean = 8.51 y.
`*Trademark of Eli Lilly and Company, Indianapolis, Indiana.
`
`96/507 (19)
`86/507 (17)
`106/507 (21)
`219/507 (43)
`
`46/507 (9)
`76/507 (15)
`229/507 (45)
`30/507 (6)
`96/507 (19)
`30/507 (6)
`
`304/507 (60)
`143/507 (28)
`50/507 (9)
`10/507 (2)
`
`40/504 (8)
`126/504 (25)
`338/504 (67)
`
`CLINICAL THERAPEUTICS’ Table II. Demographic characteristics of participants in the NovoPen@ 1.5* insulin delivery system survey (N = 507, but not all patients answered all questions). Variable No. (%) of Patients Length of time receiving insulin (y)’ <l l-3 4-9 210 Type of human insulin used 70/30 NPH NPH + regular Regular Regular + other Other Brand of insulin used Humulin@* Novolin New to insulin Other Current insulin regimen
`BID TID 96/507 (19) 86/507 ( 17) 106/507 (21) 219/507 (43) 461507 (9) 76/507 (15) 2291507 (45) 301507 (6) 96/507 (19) 301507 (6) 3041507 (60) 143/507 (28) 50/507 (9) 10/507 (2) 401504 (8) 126/504 (25) 338/504 (67) *Trademark of Novo Nordisk A/S, Copenhagen, Denmark. tMean = 8.51 y. *Trademark of Eli Lilly and Company, Indianapolis, Indiana. Approximately one third of the patients had type 1 diabetes, and 72% (536/745 patients) took insulin injections once or twice daily. Responses to the Novolin Prefilled Delivery System Survey Table II presents demographic data for When patients’ attitudes and perceptions the 507 patients who used the NovoPen about taking insulin before and after using 1.5. Age and sex data were not collected the Novolin Prebilled disposable insulin pen in this group. Almost two thirds (64%) of were compared, substantial changes in out- the patients had been taking insulin for 24 look were noted. Table III presents patients’ years, with 219 patients (43%) taking in- responses to the Novolin Prefilled delivery sulin for 210 years. Fifty (10%) of the system survey. The responses are grouped 507 patients had never taken insulin be- by category (medical, social/lifestyle, con- fore participating in this survey and thus venience, and overall evaluation) and in- were not asked to answer questions com- clude attitudes toward both the Novolin paring the syringe and pen. Prefilled delivery system and the insulin
`
`Approximately one third of the patients had
`type 1 diabetes, and 72% (536/745 patients)
`took insulin injections once or twice daily.
`Table II presents demographic data for
`the 507 patients who used the NovoPen
`1.5. Age and sex data were not collected
`in this group. Almost two thirds (64%) of
`the patients had been taking insulin for .?..4
`years, with 219 patients (43%) taking in-
`sulin for
`years. Fifty (10%) of the
`507 patients had never taken insulin be-
`fore participating in this survey and thus
`were not asked to answer questions com-
`paring the syringe and pen.
`
`Responses to the Novolin Prefilled
`Delivery System Survey
`
`When patients' attitudes and perceptions
`about taking insulin before and after using
`the Novolin Prefilled disposable insulin pen
`were compared, substantial changes in out-
`look were noted. Table III presents patients'
`responses to the Novolin Prefilled delivery
`system survey. The responses are grouped
`by category (medical, social/lifestyle, con-
`venience, and overall evaluation) and in-
`clude attitudes toward both the Novolin
`Prefilled delivery system and the insulin
`
`490
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`M.R. GRAFF AND M.A. McCLANAHAN
`
`M.R. GRAFF AND M.A. McCLANAHAN vial and syringe. Participants rated the Novolin Pretilled system higher than the syringe and vial on every measure in all four categories.
`
`vial and syringe. Participants rated the
`Novolin Prefilled system higher than the
`syringe and vial on every measure in all
`four categories.
`
`Medical
`Medical
`Six hundred seventy-two (85%) of 791
`patients did not miss any insulin injec-
`tions during the 3 weeks that they used
`the Novolin Prefilled system, and 410
`(52%) of 789 patients reported that they
`rarely or never had a high blood glucose
`level during this time. In contrast, 566
`(72%) of 789 patients indicated that they
`did not miss injections with the vial and
`syringe, and 275 (35%) of 778 reported
`
`Six hundred seventy-two (85%) of 791 patients did not miss any insulin injec- tions during the 3 weeks that they used the Novolin Prefilled system, and 410 (52%) of 789 patients reported that they rarely or never had a high blood glucose level during this time. In contrast, 566 (72%) of 789 patients indicated that they did not miss injections with the vial and syringe, and 275 (35%) of 778 reported rare or no high blood glucose levels. Ad- ditionally, 715 (90%) of 794 patients re- ported little or no pain on injection with the Novolin Prefilled system (using the NovoFine 30 insulin needle), compared with 389 (50%) of 784 patients reporting little or no pain with the vial and syringe.
`
`rare or no high blood glucose levels. Ad-
`ditionally, 715 (90%) of 794 patients re-
`ported little or no pain on injection with
`the Novolin Prefilled system (using the
`NovoFine 30 insulin needle), compared
`with 389 (50%) of 784 patients reporting
`little or no pain with the vial and syringe.
`
`SociaULifestyle
`Social/Lifestyle
`The
`The Novolin Prefilled delivery system
`had a positive impact on patients' social
`activities and lifestyle, particularly on their
`ease of maintaining dietary and exercise
`regimens: 603 (79%) of 763 patients re-
`ported that they found it easy to eat ap-
`propriately, compared with 326 (42%) of
`
`Novolin Prebilled delivery system had a positive impact on patients’ social activities and lifestyle, particularly on their ease of maintaining dietary and exercise regimens: 603 (79%) of 763 patients re- ported that they found it easy to eat ap- propriately, compared with 326 (42%) of Table III. Patients’ responses to the Novolin Prebilled@‘* insulin delivery system versus the traditional vial and syringe (N = 803, but not all patients answered all questions). Response Novolin Prefilled (%) Medical Have little or no pain on injection 90 Did not miss any injections 85 Feel better when using this method 75 Rarely/never experienced high blood glucose 52 Social/lifestyle Easy to eat appropriately 79 Easy to exercise appropriately 76 Equally likely to take insulin at home or away 64 Have a better social life on this treatment 56 Am more active when using this treatment 46 Convenience Easy to take insulin 92 Satisfied with this delivery system 84 Convenience of treatment 79 Find the treatment flexible 75 Find the method of administration convenient 79 Overall evaluation Preferred delivery system 79 Positive impact on well-being 75 Willing to continue using this treatment 88 Would recommend this method to someone else 91 *Trademark of Novo Nordisk A/S, Copenhagen, Denmark. Vial and Syringe (%) 50 72 47 36 42 38 31 17 23 39 30 32 29 34 7 47 32 39 491
`
`Medical
`Have little or no pain on injection
`Did not miss any injections
`Feel better when using this method
`Rarely/never experienced high blood glucose
`Social/lifestyle
`Easy to eat appropriately
`Easy to exercise appropriately
`Equally likely to take insulin at home or away
`Have a better social life on this treatment
`Am more active when using this treatment
`Convenience
`Easy to take insulin
`Satisfied with this delivery system
`Convenience of treatment
`Find the treatment flexible
`Find the method of administration convenient
`Overall evaluation
`Preferred delivery system
`Positive impact on well-being
`Willing to continue using this treatment
`Would recommend this method to someone else
`
`Table III. Patients' responses to the Novolin Prefilled®* insulin delivery system versus the
`traditional vial and syringe (N = 803, but not all patients answered all questions).
`
`Response
`
`Novolin Prefilled (%)
`
`Vial and Syringe (%)
`
`90
`85
`75
`52
`
`79
`76
`64
`56
`46
`
`92
`84
`79
`75
`79
`
`79
`75
`88
`91
`
`50
`72
`47
`36
`
`42
`38
`31
`17
`23
`
`39
`30
`32
`29
`34
`
`7
`47
`32
`39
`
`491
`
`*Trademark of Novo Nordisk A/S, Copenhagen, Denmark.
`
`Mylan Ex.1047
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`CLINICAL THERAPEUTICS” 776 patients who indicated the same for the vial and syringe. Five hundred sev- enty-seven (76%) of 759 patients reported that it was easy to exercise during the 3 weeks they used the Novolin Pretilled pen, compared with 304 (39%) of 780 patients who reported ease of exercising while us- ing the insulin vial and syringe. Convenience As shown in Table III, all responses re- lated to the convenience of the delivery system were positive in more than twice as many patients using the Novolin Pre- filled pen as the vial and syringe. For ex- ample, 299 (38%) of 793 patients found it “easy to take insulin” with the syringe, whereas 738 (93%) of 793 patients re- ported the same for the insulin pen. Sim- ilar differences were observed for satis- faction levels and flexibility of treatment. Overall Evaluation When asked about their personal pref- erence, 629 (79%) of 792 patients indi- cated that they preferred the Novolin Pre- filled system; 55 (7%) of 792 patients preferred the vial and syringe. Addition- ally, 591 (75%) of 788 patients stated that the insulin pen had a positive effect on their overall well-being, compared with 369 (47%) of 785 patients reporting such an effect with the vial and syringe. Pa- tients were also more willing to continue using the insulin pen (88% vs 32%) and more willing to recommend this delivery system to others (91% vs 39%) compared with the vial and syringe. Responses to the NovoPen 1.5 Survey Medical In assessing the degree of pain associ- ated with injecting insulin, 428 (90%) of the 476 patients who answered this ques- tion said that the NovoFine needle caused little or no pain, with only 48 (10%) pa- tients indicating that they found it painful. In contrast, 63 (38%) of 165 patients said that their prev