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`File name: 769757 Affidavit.pdf
`Document ID: 1 B5AC360-A2B4-11ED-83BC-3358F153F3D7
`Status: Completed
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`Document History
`
`2023-02-01
`23:43:47 EST
`2023-02-01
`23:53:57 EST
`2023-02-02
`00:12:52 EST
`2023-02-02
`00:12:52 EST
`2023-02-02
`00: 12:52 EST
`
`Document uploaded by Nathaniel Frank-White (ridge@archive.org)
`IP: 2001:569:5827:d200:9878:9d9b:5b15:65b1
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`IP: 2001:569:5827:d200:9878:9d9b:5b15:65b 1
`Document signed by Nidhi Patel
`IP: 107.23.206.220
`eNotary signed by Nidhi Patel
`IP: 107.23.206.220
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`IP: 107.23.206.220
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`Our Nota11zatjon Process
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`Page 1/4
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`MPI EXHIBIT 1013 PAGE 1
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`MPI EXHIBIT 1013 PAGE 1
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1013-0001
`
`

`

`!-ARC HI VE
`µJ
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`
`AFFIDAVIT OF NATHANIEL E FRANK-WHITE
`
`l. I am a Records Request Processor at the Internet Archive. I make this declaration
`of my own personal knowledge.
`
`2. The Internet Archive is a website that provides access to a digital library of Internet
`sites and other cultural artifacts in digital form. Like a paper library, we provide
`free access to researchers, historians, scholars, and the general public. The Internet
`Archive has partnered with and receives support from various institutions,
`including the Library of Congress.
`
`3. Tbe Internet Archive has created a service known as the Wayback Machine. The
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`Links on archived files in the Wayback Machine point to other archived files
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`by a given link. For instance, the Wayback Machine is designed such that when a
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`http://web.archive.org/web/[Year in yyyy]LMonth in mm][Day in dd][Time code in
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`http://web.archive.org/web/l 9970126045828/http://www.archive.org/ would be the
`URL for the record of the internet Archive home page HTML file
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`elements, or other embedded content) linked within that primary HTML file, the
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`
`6. Attached hereto as Exhibit A are true and accurate copies of screenshots of the
`Internet Archive's records of the archived files for the URLs and the dates specified
`in the attached coversheet of each printout.
`
`OoCllmonl Ide 1 B5AC360..A2B4-11 ED·83BG-3J56Ft 53F 307
`OnUneNotary,net
`
`111111 Qlll 111 DIIRIIIIIII IIII I IIIIUIIIH fl 111111111111 II
`
`Page 2/4
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`MPI EXHIBIT 1013 PAGE 2
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`MPI EXHIBIT 1013 PAGE 2
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1013-0002
`
`

`

`f- ARC H! VE
`J.tJ
`z
`ix:
`J.tJ
`f(cid:173)
`
`z 1111
`
`archive.org
`
`7. I declare under penalty of perjury that the foregoing is true and correct.
`
`DATE: ___ 02_1_0_2_1_2_0_23 __ _
`
`(latiu:,.tul 'f 'LMJ:.-Wli&
`Nathaniel E Frank-White
`
`Please seo attached
`All Purpose
`Jurat form
`for additional
`Notary Even!$
`
`Oo""men1 Id: 1B5AC360•A2B..., 1E0•63BC.3358F1 S3F307
`OnffneNolary .net
`
`1111111111111111111111111111111111111111111111
`
`Page 3/4
`
`MPI EXHIBIT 1013 PAGE 3
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`MPI EXHIBIT 1013 PAGE 3
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1013-0003
`
`

`

`JURAT ATTACHMENT
`
`A notary public or other officer completing this certificate verifies only the identity of the individual who signed
`the document to which this certificate is attached, and not the truthfulness, accuracy, or validity of that
`document.
`
`STATE OF
`
`Texas
`
`COUNTY OF __ H_a_r_ris ______ }
`
`The foregoing instrument was subscribed and sworn before me this date of
`02/02/2023 by
`Nathaniel Frank-White
`
`This notarial act was an online notarization.
`
`(Notary Seal)
`
`Notary's Signature ____________________ _
`
`~
`
`131579816
`Registration No.: ____ __________ ______ _
`
`Commission Expiration Date: May 23. 2026
`
`Document Id: 1B5AC360-A2B4-11E0-83BC--3358F153F307
`OnlineNotary,nel
`
`II IIIIIIIIII IIIIIIIIIIIIIIIIIIIIIIII IIIIIIIIII
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`Page4/4
`
`MPI EXHIBIT 1013 PAGE 4
`
`MPI EXHIBIT 1013 PAGE 4
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1013-0004
`
`

`

`EXHIBIT A
`EXHIBIT A
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1013-0005
`
`MPI EXHIBIT 1013 PAGE 5
`
`MPI EXHIBIT 1013 PAGE 5
`
`MPI EXHIBIT 1013 PAGE 5
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1013-0005
`
`

`

`http://web.archive.org/web/20111020123620/https://clinicaltrials.gov/ct2/show/NCT00696657
`
`MPI EXHIBIT 1013 PAGE 6
`
`MPI EXHIBIT 1013 PAGE 6
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1013-0006
`
`

`

`a:;ll1:::ll,::.:P•::::l;.;:l <;.::lln-"lea= l•:::rla:::l•:,-9e.:ov=let=2:..:l•:::h=-o':::•'.:.:N.::Cc.TO:;Oc;6;::.9:;66c:5c..7 _ _ ____ ________________________ __JI[ ~ AUG
`◄
`ll.fl!Rll!!'.ll
`280c.12C08 - 1$Apr202t
`
`2009
`
`SEP
`
`.ti2m£ ~
`
`Full Text View
`
`A Randomised Controlled Clinical Trial In Type 2 Diabetes Comparing Semaglutide to Placebo and Llraglutlde
`
`This study has been completed.
`
`First Received on June 11, 2008. Last Updated on Seplember 22, 2011 !:!ifilQjy~Qll
`
`Sponsor: Novo Nordisk
`
`Information provided by (Responsible Party): Novo Nordisk
`
`CllnlcalTrlals.gov ldentlfler: NCT00696657
`
`► Purpose
`
`This trial was conducted In Europe.Asia and Africa. Siudy participants were randomised evenly to treatment With semaglutide (0.1 mg aw - 1.6 mg aw, 6 treatmenl arms, placebo or liraglutide
`11.2 mg aD, or 1.8 mg aD). Trealment allo<:a1lon to semaglulide or placebo was double-blind, whereas liraglullde treatment was administered open-label.Primary efficacy parameter was HbA 1c
`and the treatment duratfon was 12 weeks.
`
`~
`
`Olabeles Mellltus, Type 2
`
`IDl!:0!£Dtlon
`
`Drug: semaglu1lde
`Drug: placebo
`Drug: liraglullde
`
`lliu
`
`Phase II
`
`Study Type:
`Study Design:
`
`lnterventlonal
`Allocation: Randomized
`Endpolnl Classificalion: Safety/Efficacy Study
`lnlervenlion Model: Parallel Asslgnmenl
`Masking: Double Blind (Subject, Investigator)
`Primary Purpose: Treatmenl
`
`Official Tltle:
`
`lnvestlgalion of Safety and Efficacy of Five Doses of Semaglutlde Versus Placebo and Open-label Llraglulide, as Add on Therapy, in Subje<:ls Diagnosed Wllh Type 2 Diabetes
`Currently Treated Wilh Me1formin or Controlled Wilh Diet and Exercise A 12 Week MulU-cenlre. Multi National. Double-blind. Placebo-controlled. Randomised. Nine Armed Parallel
`Group, Dose Finding Trial
`
`Resource links provided by NLM:
`
`Genetics Home Reference related topics: §.o24·related lransient neonatal diabetes meUitus
`
`MedlinePlus relaled loples: ~
`
`Ilr!ig Information available for: l.irl!9!.Y!is!!!
`u s FDA Resources
`Further study details as provided by Novo Nordisk:
`
`Primary Outcome Measures:
`• HbA1c [ Time Frame: afler 12 weeks of 1rea1menl 11 Designaled as safely issue: No]
`
`Secondary Outcome Meastires:
`• Percentage of subjects with an adverse evenls [ Time Frame: after 12 weeks of lrealmenl 11 Designaled as safety Issue: No]
`• Percentage of subjects with hypoglycaemic episoce I nme Frame: aher 12 weeks of 1rea1men111 Designated as safety issue: No I
`• Change from baseline In ECG I Time Frame: week o. week 12 ] [ Designated as safely issue: No]
`• Change from baseline In vital signs (Pulse) [ Time Frame: week 0, week 12 1 [ Designated as safety Issue: No]
`• Change from baseline in vllal signs (blood pressure) ( Time Freme: week 0, week 12 ] [ Deslgnaled as safely issue: No I
`• Change from baseline in standard safety laboralory paramelers (haemaIology) I Time Frame: weak 0, week 121 1 DesignaIed as safety issue: No I
`• Change from baseline In slandard safely laboralory paramelers ( biochemistry) I Time Frame: week 0, week 1211 Designaled as safely Issue: No]
`• Change from baseline in s1andard safety laboralory paramelers (urinalysis) [ Time Frame: week O. week 12) [ Designaled as safely issue: No I
`• Change from baseline in calcllonin [ Time Frame: weak 0, week 12 ] I Designated as safety Issue: No]
`• Percenlege of subjects developing anti-semaglulide anlibodies I Time Frame: afler 12 weeks of lrealmenl ) [ Designaled as safely issue: No ]
`
`Enrollment
`Sludy Start Dale:
`Sludy Completion Dale:
`Primary Completion Dale:
`
`415
`June 2008
`February 2009
`February 2009 (Final data collection dale for primary outcome measure)
`
`8.cmi
`
`A: Experlmenlal
`Intervention: Drug: semaglulide
`
`8: Experimental
`lnlervention: Drug: semaglutide
`
`C: Experimenlal
`Intervention: Drug: semaglutide
`
`D: Experimental
`Intervention: Drug: semaglutide
`
`All!gned 1ote1Yet!l[ons
`
`Drug: semaglutide
`0.1 mg, once weekly, s.c. injection
`
`Drug: semaglullde
`0.2 mg. once weekly, s.c. injection
`
`Drug: semaglulide
`0.4 mg, once weekly, s.c. Injection
`
`Drug: semagluUde
`0.8 mg, once weekly, s.c. Injection
`
`MPI EXHIBIT 1013 PAGE 7
`
`MPI EXHIBIT 1013 PAGE 7
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1013-0007
`
`

`

`E: Experimental
`Intervention: Drug: semeglullde
`
`F: Experimental
`Intervention: Drug: semaglulide
`
`G 1: Placebo Comparator
`lntervenlion: Drug: placebo
`
`G2: Placebo Comparator
`lnlervention: Drug: placebo
`
`G3: Placebo Comparator
`Intervention: Drug: placebo
`
`G4: Placebo Comparator
`Intervention: Drug: placebo
`
`GS: Placebo Comparator
`Intervention: Drug: placebo
`
`G6: Placebo Comparator
`Intervention: Drug: placebo
`
`H : Experimental
`Intervention: Drug: liraglutlde
`
`I: Experimental
`lntervenlion: Drug: llraglullde
`
`► Eligibility
`
`Ages E liglble for Study:
`Genders Eligible for Study:
`Accepts Healthy Vol unteers:
`
`18 Years and older
`Both
`No
`
`Drug: semaglulide
`0.8 mg with titration. once weekly, s.c. lnjeclion
`
`Drug: semaglulide
`1.6 mg with titration, once weekly, s.c. injection
`
`Drug: placebo
`0.1 mg, once weekly, s.c. lnjectlon
`
`Drug: placebo
`0.2 mg, once weekly, s.c. injection
`
`Drug: placebo
`0.4 mg, once weekly, s.c. Injection
`
`Drug: placebo
`0.8 mg with ti1tatlon, once weekly, s.c. injeclion
`
`Drug: placebo
`0.8 mg with titration, once weekly, s.c. Injection
`
`Drug: placebo
`1.6 mg, once weekly, s.c. lnjeclion
`
`Drug: liraglulide
`1.2 mg wllh titration, once dally, s.c. Injection
`
`Drug: llraglutlde
`1.8 mg wllh titration, once daily, s.c. Injection
`
`Crtterla
`Inclusion Criteria:
`• Men and women-not-of-chlldbea~ng potential diagnosed with type 2 diabetes for at least three months
`• Stable treatment regimen with ellher metformin (al leasl 1500 mg) or diet and exercise alone for at least three monlhs
`• HbAtc: 7.0-10.0 % (both inclusive)
`• Body weigh! between 60 kg and 11 O kg
`
`Exclusion Criteria:
`, Trea1men1 wllh Insulin. GLP-1 receptor agonlsls (Including llraglutlde), dlpeptldyl peplldase-4 inhibitors, sulphonylurea, lhiazolldlnedlones, Alpha-Gls, or any lnvesligatlonal drug.
`within the last three monU1s
`• Impaired liver or kidney function
`• Prollterative retinopathy or maculopalhy requiring acule trea1men1
`, Clinically slgnlficanl acllve cardlovasct1lar disease and unconlrolled treated/untrealed hypertension
`• Recurrent major hypoglycaemia or hypoglycaemic unawareness
`• Presenl or planned use of any drug which could Interfere wll h the glt1cose levels (e.g. systemic corticosteroids)
`
`► Contacts and Locations
`
`Please refer 10 this study by 11s CllnlcalT~als.gov Identifier: NCT00696657
`
`Locations
`
`Austria
`
`Wien, Austria. 1010
`
`Bulgaria
`Russe, Bt1lgarla, 7000
`
`Finland
`
`Turku, Finland, 20520
`
`Former Serbia and Montenegro
`Belgrade, Former Serbia and Mon1enegro, 11000
`
`France
`
`MONTPELLIER cedex 5, France, 34295
`
`Germany
`Pohlhelm, Germany, 35415
`
`Hungary
`Budapesl. Hungary, H- 1045
`
`India
`
`Italy
`
`Chennai, India, 600086
`
`Chietl Scalo, Italy, 660 13
`
`South Africa
`Durban, KwaZulu-Natal, Soulh Africa. 4091
`
`Spain
`
`Almeria, Spain, 04001
`
`Switzerland
`Gen~ve 14, Switzerland, 1211
`
`Turkey
`
`Istanbul, Turkey, 34390
`
`MPI EXHIBIT 1013 PAGE 8
`
`MPI EXHIBIT 1013 PAGE 8
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1013-0008
`
`

`

`United Kingdom
`Bexhlll-on-Sea, United Kingdom, TN39 4SP
`
`Sponsors and Collaborators
`
`Novo Nordisk
`
`Investigators
`Study Director: ChrtsUne 8 . Jensen, MO, PhD Novo Nordisk
`
`► More Information
`
`Additional Information:
`
`Clinical TriAls at Novo Nordisk ~
`
`No publications provided
`
`Responsible Party:
`ClinlcalTrlals.gov Identifier:
`Oiher S1udy ID Numbers:
`Study First Received:
`Last Updated:
`Health Authority:
`
`Novo Nordisk
`NCT00696657
`lii§jo[y~IJil
`NN9535-1821, 2007-003956-12
`June 11, 2008
`September 22, 2011
`Austria: Federal Ministry for Health and Women: Bulga~a: Bulgarian Drug Ag ancy: Finland: Finnish Medicines Agency: France: Afssaps • French Health Procucts
`Safety Agency: German y: Federal Institute for Drugs and Medical Devices: Hungary: National Institute of Pharmacy:
`India: Ministry o f Health: Italy: National
`Monito<lng Centre for Clinical Trials - Ministry of Heallh: Serbia: Medicines and Medical Devices Agency of Serbia: South Africa: Medicines Control Council:
`Spain: Spanish Agency of Medicines: SwilZerland: Laws and standards: Turkey: Ministry of Health: United Kingdom: Medicines and Healthcare Products
`Regulatory Agency
`
`Addllionat relevant MeSH terms:
`Diabetes Mellltus
`Diabetes Mellitus, Type 2
`Glucose Metabolism Disorders
`Metabolic Diseases
`Endocrine System Diseases
`Glucagon-Llke Peptide 1
`
`CllnlcolTrlols.gov processed this record on October 18, 2011
`
`lncretlns
`Ho<mones
`Hormones, Hormone Substitutes, and Hormone Antagonists
`Physiological Effects of Drugs
`Pharmacologlc Actions
`
`~~
`I fi:,lm: HiH NatiQnal Ptotn foe Bioo'ftrtmil' CQmmuniralbns- US NillkJMI I ffl'o(Y ~
`11 s Wtlianat ID1if11111H ot HM'm- ll.£..Q8 earto¥mt o! H@llh & Hurnao Se@5
`. Frnftdom or h)forn1adim'Ad
`1.!.SA.Q!:!Y, ~.11. ~>'~ ~
`
`-
`
`MPI EXHIBIT 1013 PAGE 9
`
`MPI EXHIBIT 1013 PAGE 9
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1013-0009
`
`

`

`http://Web.archive.org/web/2011080402l928/https://clinicaltrials.gov/ct2/show/NCT00696657
`
`MPI EXHIBIT 1013 PAGE 10
`
`MPI EXHIBIT 1013 PAGE 10
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1013-0010
`
`

`

`______ 11;..rta;...I,;...go""-v--1c--•2_1s_h_o1_vl_N_C_To_o ... 6 ... 9 ... 66 ... 5_7 ______________________________ __,I [ <EJ JUN
`OCT
`Llh ___ np,;..s;..:1 __ 1c ___ lln ___ Ica
`◄ I • ►
`26 call!l!!ll
`2009
`2012
`260a20()8.-l~A.p'2021
`H2m! ~
`
`ClinicalTrials.gov
`
`A t,tf\lfu al tM U.S. H.-tlanal lnstitulu al Ht~th
`
`Full Text View
`
`A Randomised Controlled Clinical Trial In Type 2 Diabetes Comparing Semaglutlde to Placebo and Llraglutlde
`
`This study has been completed.
`
`First Received on June 11, 2008. Last Updated on March 16, 2011 J::lwQ[y~g~
`
`Sponsor: Novo Nordisk
`
`Information provided by: Novo Nordisk
`
`ClinlcalTrlals.gov Identifier: NCT00696657
`
`► Purpose
`
`This tr1al was conducted In Europe.Asia and Africa. Study partlclpants were randomised evenly to treatment with semaglutide (0.1 mg OW• 1.6 mg OW, 6 treatment arms, placebo or liraglutide
`( 1.2 mg OD. or 1.8 mg OD).Treatment allocation to semaglutide or placebo was double-blind, whereas liraglutide treatment was administered open-label.Primary efficacy parameter was HbA 1 c
`and the treatment duration was 12 weeks.
`
`~
`
`Diabetes Mellitus. Type 2
`
`loteri:eotion
`
`Drug: semagl111lde
`Drug: placebo
`Drug: llraglutlde
`
`Phase
`
`Phase II
`
`Study Type:
`Study Design:
`
`lnterventlonal
`Allocation: Randomized
`Endpoint Clessification: Safety/Efficacy Sludy
`Intervention Model: Parallel Assignment
`Masking: Double Bline (Subject, lnvesligalor)
`Primary Purpose: Trea1men1
`
`Officlal Title:
`
`Investigation of Safety and Efficacy of Five Doses of Semaglutide Versus Placebo and Open-label Liraglutide. as Add on Therapy, in Subjecls Diagnosed With Type 2 Diabetes
`Currently Treated With Metformln or Controlled With Diel and Exercise A 12 Week Multi,cenire, Mulll National, Double-blind, Placebo-controlled, Randomised. Nine Armed Parallel
`Group, Dose Finding Trial
`
`Resource links provided by NLM:
`
`Geoelics Home Reference related topics: §$124-relaled transient neonatal diabetes mellitus
`
`MedlinePlus relaled 1opics: ~
`
`Qn!g Information available for: l.lli!g~
`u s EPA Resources
`Funher study details as provided by Novo Nordisk:
`
`Primary Outcome Measures:
`• HbA1c ( Time Frame: after 12 weeks of lrealmenl) ( Designated as safely issue: No)
`
`Secondary Outcome Measures:
`• Percentage of subjecls wilh an adverse events ( Time Frame: after 12 weeks of treatmenl 11 Designated as safely issue: No I
`• Percentage of subjects wtth hypoglycaemic episode ( Time Frame: after 12 weeks of treatment I [ Designated as safety issue: No I
`• Change from baseline in ECG I Time Frame: week 0, week 12) ( Designaled as safely Issue: No)
`• Change from baseline in vital signs (Pulse) ( Time Frame: week 0, week 12) ( Designated as safely issue: No)
`• Change from baseline In vital signs (blood pressure) I Time Frame: week 0, week 12 I ( Designated as safety issue: No)
`, Change from baseline in standard safety laboralory parameters (haematology) I Time Frame: week 0, week 12 I ( Designated as safety Issue: No I
`• Change from baseline In s1andard safely laboratory parameters ( biochemlslry) [ Time Frame: week 0, week 12 ) ( Designated as safety issue: No)
`• Change from baseline in s1andard safety laboralory parameters (urinalysis) ( Time Frame: week 0, week 12) ( Designated as safely issue: No J
`• Change from baseline in calcilonln ( Ttme Frame: week 0. week 12 J ( Deslgnaled as safety issue: No}
`• Percenlage of subjects developing anll-semaglutide antibodies ( Time Frame: af1e,· 12 weeks of treatmenl ) [ Designated as safely issue: No J
`
`415
`Enrollment:
`June 2008
`Study Stan Date:
`February 2009
`Study Completion Date:
`Primary Completion Dale: February 2009 (Final data collection dale for primary outcome measure)
`
`8rmi
`
`A: Experimental
`Intervention: Drug: semaglutlde
`
`B: Experimenlal
`Intervention: Drug: semaglutide
`
`C: Experimental
`Intervention: Drug: semaglutide
`
`D: Experimental
`Intervention: Drug: semaglutide
`
`~gas:~ laliC£•nllons
`
`Drug: semaglullde
`0.1 mg, once weekly, s.c. Injection
`
`Drug: semaglutide
`0.2 mg, once weekly, s.c. Injection
`
`Drug: semaglutide
`0.4 mg, once weekly, s.c. injection
`
`Drug: semaglutide
`0.8 mg, once weekly, s.c. injection
`
`MPI EXHIBIT 1013 PAGE 11
`
`MPI EXHIBIT 1013 PAGE 11
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1013-0011
`
`

`

`E: Experlmenlal
`lntervenllon: Drug: semaglutlde
`
`F: Experimental
`Intervention: Drug: semaglutide
`
`G1: Placebo Comparator
`Intervention: Drug: placebo
`
`G2: Placebo Comparator
`lnlervenlion: Drug: placebo
`
`G3: Placebo Comparator
`Intervention: Drug: plawbo
`
`G4: Placebo Comparalor
`Intervention: Drug: placebo
`
`GS: Placebo Comparator
`Intervention: Drug: placebo
`
`G6: Placebo Comparator
`Intervention: Drug: placebo
`
`H: Experimental
`lntervenllon: Drug: llraglutide
`
`I: Expertmental
`Intervention: Drug: liraglutlde
`
`Drug: semaglutide
`0.8 mg wllh titration, once weekly, s.c. Injection
`
`Drug: semaglutide
`1.6 mg with tltration, once weekly, s.c. injection
`
`Drug: placebo
`0.1 mg, once weekly, s.c. injection
`
`Drug: placebo
`0.2 mg, once weekly, s.c. Injection
`
`Drug: placebo
`0.4 mg, once weekly, s.c. injection
`
`Drug: placebo
`0.8 mg with tilration, once weekly, s.c. Injection
`
`Drug: placebo
`0.8 mg with litratlon, once weekly, s.c. Injection
`
`Drug: placebo
`1.6 mg, once weekly, s.c. injection
`
`Drug: liraglulide
`1.2 mg with titration, once daily, s.c. Injection
`
`Drug: llraglutide
`1.8 mg v.ith tilration, once dally, s.c. injection
`
`► Eligibility
`
`Ages Eligible for Study:
`Genders Eligible for Study:
`Accepts Heallhy Volunteers:
`
`18 Years and older
`Both
`No
`
`Criteria
`Inclusion Crtteria:
`• Men and women-not-of·chlldbearlng potential diagnosed with type 2 diabetes for al ieasl lhree months
`• Stable treatment regimen wilh ellher metlormln (at least 1500 mg) or dial and exercise alone for at teasl three mon1hs
`• HbA1c: 7.0-1 0.0 % (both Inclusive)
`• Body weight between 60 kg end 110 kg
`
`Exclusion Criteria:
`• Trealment wilh insulin, GLP·1 receptor agonlsts (Including llraglullde), dlpeptldyi peptldase-4 Inhibitors, sulphonylurea, lhlazolldlnedlones, Alpha,Gls, or eny lnvesllgatlonal drug,
`within the last three mon01s
`• Impaired liver or kidney function
`• Proliferative retlnopathy or maculopathy requiring acute treotmenl
`• Clinically signlflcant active cardiovascular disease and uncontrolled treated/untreated hypertension
`• Recurrent major hypoglycaemia or hypoglycaemic unawareness
`• Present or planned use of any drug which could In terfere with Iha glucose levels (e.g. syslemic corticosteroids)
`
`► Contacts and Locations
`
`Please refer to lhis study by Its ClinlcalTrlals.gov Identifier: NCT00696657
`
`Locations
`
`.Austria
`
`Wien. Austria, 1010
`
`Bulgaria
`Russe, Bulgaria, 7000
`
`Finland
`
`Oulu, Finland, 90029
`
`Former Serbia and Montenegro
`Belgrade, Former Serbia and Montenegro, 11000
`
`France
`
`MONTPELLIER cedex 5, France, 34295
`
`Garmany
`Pohlhelm, Germany, 35415
`
`Hungary
`Budapest. Hungary, H-1045
`
`India
`
`Italy
`
`Chennai, India, 600020
`
`Chletl Scalo, Italy, 66013
`
`South Africa
`Cape Town, Western Cape, Soulh Africa, 7925
`
`Spain
`
`Almeria, Spain, 04001
`
`Switzerland
`KOsnacht, Switze~and, 8700
`
`Turkey
`
`Istanbul, Turkey, 34390
`
`MPI EXHIBIT 1013 PAGE 12
`
`MPI EXHIBIT 1013 PAGE 12
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1013-0012
`
`

`

`United Kingdom
`Bexhlll-on-Sea, United Kingdom, TN39 4SP
`
`Sponsors and Collaborators
`Novo Notdlsk
`
`Investigators
`Study Directot: Christine B. Jensen, MD, PhD Novo Nordisk
`
`► More Information
`
`Additional lnfotmatlon:
`
`Ctlnlcal Trlals at Novo Nordisk .,,tj
`
`No publiClltlons provided
`
`Novo Nordisk NS ( Public Access to Clinical Trials )
`Responsible Party:
`ClinlcalTrials.gov Identifier: NCT00696657
`l:!lfil2!y..21.Qmog~
`Other Study ID Numbers: NN9535-1821, 2007-003956-12
`Sludy Firs! Received:
`June 11, 2008
`March 16, 2011
`Las I Updated:
`Austria: Federal Mlnlstry lot Heallh end Women: Bulgaria: Bulgarian Drug Agency: Finland: Finnish Medicines Agency: France: Afsseps - French Health Producls
`Health Aulhorlty:
`India: Ministry of Heallh: Italy: National
`Safely Agency: Germany: Federal lnslllute for Drugs end Medical Devices: Hungary: National lnstltule or Pharmacy:
`Monltor1ng Cenlre for Clinical Trials. Ministry of Heallh: Serbia: Medicines and Medical Devices Agency of Serbia: South Africa: Medicines Control Council:
`Spain: Spanish Agency of Medicines; Swllzerland: La1'is and standards: Turkey: Ministry of Heallh: Uniled Kingdom: Medicines and Heallhcare Products
`Regulatory Agency
`
`Additional relevant MeSH terms:
`Diabetes Mellltus
`Diabetes Mellilus, Type 2
`Glucose Metabolism Disorders
`Melabollc Diseases
`Endocrine Syslem Diseases
`Glucagon-Uke Peptide 1
`
`ClinlcalTriols.gov processed lhls record on Augusl 01, 2011
`
`lncrellns
`Hormones
`Hormones, Hormone Subslllules, and Hormone Anlagonlsls
`Physiological Effects of Drugs
`Pharmawloglc Acllons
`
`~..ilb!;
`l i51m: Hill Natiorwl C'.&otm: fQr Ri1?JDeskial Cooml!mir,a1iQQ,; US Na!Joo.,1 I l>rnrv~
`lJ $ N8!iooal IP"fillf'O\'i 9' HMJlb ~Mft!OOOI of Heaftb & Humon Se009fl3
`~gm,. ~
`~x. ~
`·. frffl99'Doftof01mi!liPoAct
`
`MPI EXHIBIT 1013 PAGE 13
`
`MPI EXHIBIT 1013 PAGE 13
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1013-0013
`
`

`

`http://web.archive.org/web/20110625004803/https://clinicaltrials.gov/ct2/show/NCT00696657
`
`MPI EXHIBIT 1013 PAGE 14
`
`MPI EXHIBIT 1013 PAGE 14
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1013-0014
`
`

`

`lhHps~/clinicaltrials.gov1cl2/showlNCT00696657
`
`.llSi!P.ll!W
`28 OGI 2',"\13 • 1~ AJif 2021
`
`Full Text View
`
`AUG
`
`A Randomised Controlled Clinical Trial In Type 2 Diabetes Comparing Semaglutlde to Placebo and Llraglutlde
`
`This study has been completed.
`
`First Received on June 11, 2008. Last Updated on March 16, 2011 J:lwl!ry..2!J,hrulgn
`
`Sponsor: Novo Nordisk
`
`Information provided by: Novo Nordisk
`
`CllnlcalTtlals.gov Identifier: NCT00696657
`
`► Purpose
`
`This trial was conducted in Europe.Asia and Africa. Study participants were randomised evenly to treatment with semaglutide (0.1 mg OW - 1.6 mg OW, 6 treatment arms, placebo or liraglutlde
`(1.2 mg OD. or 1.8 mg QD).Treatment allocation to semaglutlde or placebo was double-blind, whereas liraglulide treatment was administered open-label.Primary efficacy parameter was HbA1c
`and lhe treatment duration was 12 weeks.
`
`~
`
`Diabetes Mellltus, Type 2
`
`!ate[Yentfon
`
`Drug: semaglutlde
`Drug: placebo
`Drug: llraglutide
`
`Phase
`
`Phase II
`
`Study Type:
`Study Design:
`
`lnterventlonal
`Allocation: Randomized
`Endpoint Closslficatlon: Safety/Efficacy Study
`Intervention Model: Parallel Assignment
`Masking: Double Blind (Subject , Investigator)
`Primary Purpose: Treatment
`
`Official Tille:
`
`Investigation of Safety and Efficacy of Five Doses of Semaglullde Versus Placebo and Open-label Liraglulide. as Add on Therapy, In Subjects Diagnosed With Type 2 Diabetes
`Currently Treated With Metformln or Controlled With Diel and Exercise A 12 Week Multl•centre, Multi National, Double-bl Ind, Placebo-controlled, Randomised. Nine Armed Parallel
`Group, Dose Finding Trial
`
`Resource links provided by NLM:
`
`Genetics Home Reference related topics: ~24·related transient neonalal diabetes mellitus
`
`MedlinePJus related topics: Diabetes
`
`l2!J.!g Information available for: l.l!l!g!l!lli!e
`u.s. FDA Resources
`Further study details as provided by Novo Nordisk:
`
`Primary Outcome Measures:
`• HbA1c ( Time Frame: after 12 weeks of treatment J ( Designated as safety issue: No )
`
`Secondary Outcome Measures:
`• Percentage of subjects with an adverse events ( Time Frame: after 12 weeks of treatment) ( Designated as safety Issue: No)
`• Percentage of subjects with hypoglycaemic episode ( Time Frame: after 12 weeks of treatment) l Designated as safety issue: No J
`• Change from baseline in ECG ( Time Frame: week 0, week 12 I I Designated as safely issue: No I
`• Change from baseline in vital signs (Pulse) [ Time Frame: week 0. week 12 ) ( Designated as safety Issue: No]
`• Change from baseline in vital signs (blood pressure) ( Time Frame: week 0. week 12) I Designated as safety issue: No J
`• Change from baseline In standard safety laboratory parameters (haematology) I Time Frame: week 0, week 12 JI Designated as safety issue: No I
`• Change from baseline in standard safety laboratory parameters ( biochemistry) { Time Frame: week 0. week 12) ( Designated as safety issue: No ]
`• Change from baseline In slandard safety laboratory parameters (urinalysis) I Time Frame: week 0, week 12) ( Designated as safety Issue: No]
`• Change from baseline in calcitonin ( lime Frame: week 0, week 12 ) [ Designated as safety issue: No)
`• Percentage of subjects developing anti-semaglutide antibodies ( Time Frame: after 12 weeks of treatment] ( Designated as safety issue: No]
`
`Enrollment:
`415
`June 2008
`Study Start Date:
`February 2009
`Study Completion Date:
`Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
`
`ADM
`
`A: Experimental
`Intervention: Drug: semaglulide
`
`B: Experimental
`lnlerventlon: Drug: semaglutide
`
`C: Experimental
`lntervent.ion: Drug: semaglutide
`
`D: Experimental
`Intervention: Drug: semaglutide
`
`Mfilgne!! lolei:n□lloo:.
`Drug: semaglutide
`0.1 mg, once weekly, s.c. injection
`
`Drug: semaglUlide
`0.2 mg, once weekly, s.c. Injection
`
`Drug: sernaglulide
`0.4 mg, once weekly, s.c. injection
`
`Drug: semaglutide
`0.8 mg, once weekly, s.c. injection
`
`MPI EXHIBIT 1013 PAGE 15
`
`MPI EXHIBIT 1013 PAGE 15
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1013-0015
`
`

`

`E: Experimental
`Intervention: Drug: semaglullde
`
`F: Experimental
`Intervention: Drug: semaglulide
`
`G1: Placebo Comparator
`Intervention: Drug: placebo
`
`G2: Placebo Comparator
`lnlerventlon: Drug: placebo
`
`G3: Placebo Comparator
`Intervention: Drug: placebo
`
`G4: Placebo Comparator
`Intervention: Drug: placebo
`
`GS: Placebo Comparator
`lnlervenllon: Drug: placebo
`
`G6: Placebo Comparator
`Intervention: Dnig: placebo
`
`H: E•perlmental
`Intervention: Drug: llroglutide
`
`I: E>perlmental
`Intervention: Drug: liraglullde
`
`Drug: semaglutlde
`0.8 mg with Ill ration, once weekly, s.c. Injection
`
`Drug: semaglutlde
`1.6 mg with titration, once weekly, s.c. Injection
`
`Dnig: placebo
`0.1 mg, once weekly. s.c. Injection
`
`Drug: placebo
`0.2 mg, once weekly, s.c. injection
`
`Drug: placebo
`0.4 mg, once weekly, s.c. Injection
`
`Drug: placebo
`0.8 mg with titration, once weel<ly, s.c. Injection
`
`Drug: placebo
`0.8 mg with tllration, once weekly, s.c. Injection
`
`Drug: placebo
`1.6 mg, once weekly. s.c. injection
`
`Drug: liraglutlde
`1.2 mg with titration, once daily, s.c. injection
`
`Drug: llraglutlde
`1.8 mg with titration, once daily, s.c. Injection
`
`► Eligibility
`
`Ages Eligible for Study:
`Genders Eligible for Study:
`Acoepts Heallhy Volunteers:
`
`18 Years and older
`Both
`No
`
`Criteria
`lncluslon Criteria:
`• Men and women-nol-of-chlldbearlng potenllal diagnosed with type 2 diabetes for at least three months
`• Stable treatment regimen with either metformln (al least 1500 mg) or diet and exercise alone for al least three months
`• HbA1c: 7.0-10.0 % (both inclusive)
`• Bodyweight between 60 kg and 110 kg
`
`Exclusion Criteria:
`• Tteatmenl with Insulin. GLP-1 receptor agonlsts (Including liraglutlde). dlpeplldyl peplldase-4 lnhlbllors, sulphooylurea. lhlezolldlnedlones, Alphe-Gls, or any lnvesligatlonal drug,
`wilhln the last three months
`• Impaired liver or kidney function
`• Prollferatlve retlnopathy or maculopathy requiring acute treatment
`• Clinically significant active cardiovascular disease and uncontrolled lrealedluntrealed hypenenslon
`• Recurrent major hypoglycaemia or hypoglycaemic unawareness
`• Present or planned use of any drug which could interfere with the glucose levels (e.g. systemic corticosteroids)
`
`► Contacts and Locations
`
`Please refer 10 this study by Us CllnlcalTrlals.gov Identifier: NCT00696657
`
`Locations
`
`Austria
`
`Wien, Austria. 1010
`
`Bulgaria
`Russe, Bulgaria. 7000
`
`Finland
`
`Oulu. Finland, 90029
`
`Former Serbia and Montenegro
`Belgrade. Former Serbia and Montenegro. 11000
`
`MONTPELLIER cedex 5. France, 34295
`
`Germany
`Pohlhelm, Germany, 35415
`
`Hungary
`Budapest, Hungary, H-1045
`
`India
`
`Italy
`
`Chennal, India, 600020
`
`Chietl Scalo. Italy. 66013
`
`South Africa
`Cape Town, Western Cape. South Africa, 7925
`
`Spain
`
`Almeria, Spain, 04001
`
`Switzerland
`K0snacht, Switzerland, 8700
`
`Turkey
`
`Istanbul, Turkey, 34390
`
`MPI EXHIBIT 1013 PAGE 16
`
`MPI EXHIBIT 1013 PAGE 16
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1013-0016
`
`

`

`United Kingdom
`Bexhlll-on-Sea, United Kingdom, TN39 4SP
`
`Sponsors and Collaborators
`Novo Nordisk
`
`lnV8stigators
`Study Director: Christine B. Jensen. MD. PhD Novo Nordisk
`
`► More Information
`
`Addlllonal lnformallon:
`Cllo!cal Trials el Novo Nordisk ~
`
`No publlcallons provided
`
`Responsible Party:
`ClinicalTrlals.gov Identifier:
`Other Study ID Numbers:
`Siudy First Received:
`Lasl Updated:
`Health Author11y:
`
`Novo Nordisk NS ( Public Acc