Clinical trial NCT02648204
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2016-01-06; Completion date: 2017-05-19
Enrollment: 1201 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: semaglutide intervention 2: Dulaglutide
Intervention descriptions: intervention 1: Administered subcutaneously (s.c., under the skin) once-weekly. intervention 2: Administered subcutaneously (s.c., under the skin) once-weekly.

Protocol documents:
Prot_000.pdf: 




6IHEGXIHTVSXSGSP
-RGPYHIWVIHEGXMSRSJTIVWSREPMHIRXMJMEFPIMRJSVQEXMSRSRP]
































































































































































































































































(MVIGXMSRWJSVYWIJSVQP 4(7TIRMRNIGXSV
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Directions for use for 1.5 ml PDS290 pen-injector  
For clinical trial use 
Trial ID: NN9535-4216 
Applies to: Semaglutide
8 of 15 
                             Version: 1.5 ml pre-filled PDS290 pen-injector-solution for injection-v04-EN
You can select up to 1.0 mg per dose. When your pen contains less than 1.0 
mg, the dose counter stops before 1.0 is shown. If you need more drug 
product than the number of mg left in your pen-injector, use a new pen-
injector to inject the dose you need. (SRSXWTPMXXLIHSWIFIX[IIRX[S
TIRMRNIGXSVW
The dose selector clicks differently when turned forward, backwards or past the 
dose left in the pen-injector. Do not count the pen clicks.
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Do not count the pen clicks. 3RP]HSWIWSJQKSVQKSV
QKGERFIWIPIGXIH[MXLXLIHSWIWIPIGXSV The selected dose must 
line up precisely with the dose pointer to ensure that you get a correct 
dose. 


Directions for use for 1.5 ml PDS290 pen-injector  
For clinical trial use 
Trial ID: NN9535-4216 
Applies to: Semaglutide
9 of 15 
                             Version: 1.5 ml pre-filled PDS290 pen-injector-solution for injection-v04-EN
 -RNIGX]SYVHSWI
% -RWIVXXLIRIIHPIMRXS]SYVWOMRas your 
doctor or nurse has shown you.  
1EOIWYVI]SYGERWIIXLIHSWIGSYRXIV.
Do not cover it with your fingers. This could
interrupt the injection.
& 4VIWWERHLSPHHS[RXLIHSWIFYXXSR
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The 0 must line up with the dose pointer. You 
may then hear or feel a click. 
' /IITXLIRIIHPIMR]SYVWOMREJXIV the dose 
counter has returned to 0 andGSYRXWPS[P]
XS
If the needle is removed earlier, you may see 
a stream of drug product coming from the 
needle tip. If so, the full dose will not be 
delivered. 
%
&
'
Count slowly: 


Directions for use for 1.5 ml PDS290 pen-injector  
For clinical trial use 
Trial ID: NN9535-4216 
Applies to: Semaglutide
10 of 15 
                             Version: 1.5 ml pre-filled PDS290 pen-injector-solution for injection-v04-EN
( 6IQSZIXLIRIIHPIJVSQ]SYVWOMR
If blood appears at the injection site, press 
lightly. Do not rub the area.
You may see a drop of drug product at the 
needle tip after injecting. This is normal and 
does not affect your dose. 
(
%P[E]W[EXGLXLIHSWIGSYRXIVXSORS[LS[QER]QK]SYMRNIGX
Hold the dose button down until the dose counter shows 0. 
,S[XSMHIRXMJ]EFPSGOIHSVHEQEKIHRIIHPI#
If 0 does not appear in the dose counter after continuously pressing the 
dose button, you may have used a blocked or damaged needle. 
In this case  you have RSX received ER] drug product  even though the 
dose counter has moved from the original dose that you have set. 
,S[XSLERHPIEFPSGOIHRIIHPI#
Change the needle as described in section 5 and repeat all steps starting 
with section 1: Prepare your pen with a new needle. Make sure you select 
the full dose you need. 
2IZIVXSYGLXLIHSWIGSYRXIV[LIR]SYMRNIGXThis can interrupt the 
injection. 


Directions for use for 1.5 ml PDS290 pen-injector  
For clinical trial use 
Trial ID: NN9535-4216 
Applies to: Semaglutide
11 of 15 
                             Version: 1.5 ml pre-filled PDS290 pen-injector-solution for injection-v04-EN
 %JXIV]SYVMRNIGXMSR
% 0IEHXLIRIIHPIXMTMRXSXLISYXIVRIIHPI
GETon a flat surface without touching the 
needle or the outer cap. 
& Once the needle is covered,GEVIJYPP]TYWL
XLISYXIVRIIHPIGETGSQTPIXIP]SR
Unscrew the needle and dispose of it carefully. 
' 4YXXLITIRGETSRyour pen-injector after 
each use to protect the drug product from 
light. 
%
&
'


Directions for use for 1.5 ml PDS290 pen-injector  
For clinical trial use 
Trial ID: NN9535-4216 
Applies to: Semaglutide
12 of 15 
                             Version: 1.5 ml pre-filled PDS290 pen-injector-solution for injection-v04-EN
%P[E]WHMWTSWISJXLIRIIHPIEJXIVIEGLMRNIGXMSRto ensure convenient 
injections and prevent blocked needles. If the needle is blocked, you will RSX
inject any drug product. 
4PIEWIOIITEPPYWIHERHYRYWIHTIRMRNIGXSVWERHVIXYVRXLIQXS]SY
HSGXSVSVRYVWIEWMRWXVYGXIH Please dispose of all used needles as 
instructed by your doctor or nurse. 
2IZIVXV]XSTYXXLIMRRIVRIIHPIGETFEGOSRXLIRIIHPIYou may 
stick yourself with the needle.
%P[E]WVIQSZIXLIRIIHPIJVSQ]SYVTIRMRNIGXSVEJXIVIEGL
MRNIGXMSRThis may prevent blocked needles, contamination, infection, 
leakage of drug product and inaccurate dosing. 


(MVIGXMSRWJSVYWIJSVQP 4(7TIRMRNIGXSV
*SVGPMRMGEPXVMEPYWI
8VMEP-(22
%TTPMIWXS7IQEKPYXMHI
SJ
:IVWMSRQPTVIJMPPIH4(7TIRMRNIGXSVWSPYXMSRJSVMRNIGXMSRZ)2
How much drug product is left
A. To see how much drug product is left,XYVR
XLIHSWIWIPIGXSV
-J]SYGERXYVRXLIHSWIWIPIGXSVYRXMPXLIHSWI
GSYRXIVWLS[WEXPIEWXQKMWPIJXMR
]SYVTIRMRNIGXSV
-JXLIdose counter stops before 1.0 mg
XLIVIMWRSXIRSYKLHVYKTVSHYGXPIJXJSVEJYPP
HSWISJQK
(SRSXWTPMX]SYVHSWI9WIERI[TIRMRNIGXSV
MJ]SYRIIHQSVIHVYKTVSHYGXXLERXLIQK
PIJXMR]SYVTIRMRNIGXSV
A
(SWI
GSYRXIV
WXSTTIH
QKPIJX


(MVIGXMSRWJSVYWIJSVQP 4(7TIRMRNIGXSV
*SVGPMRMGEPXVMEPYWI
8VMEP-(22
%TTPMIWXS7IQEKPYXMHI
SJ
:IVWMSRQPTVIJMPPIH4(7TIRMRNIGXSVWSPYXMSRJSVMRNIGXMSRZ)2
Caring for your pen-injector
Do not leave your pen-injector in a carSVSXLIVTPEGI[LIVIMXGERKIX
XSSLSXSVXSSGSPH
Do not expose your pen-injector to dust, dirt or liquid. 
Do not wash, soak or lubricate your pen-injector. -JRIGIWWEV]GPIER
MX[MXLQMPHHIXIVKIRXSREQSMWXIRIHGPSXL
Do not drop your pen-injector SVORSGOMXEKEMRWXLEVHWYVJEGIW-J]SY
HVSTMXSVWYWTIGXETVSFPIQEXXEGLERI[RIIHPIERHGLIGOXLIHVYK
TVSHYGXJPS[FIJSVI]SYMRNIGX
Do not try to refill your pen-injector. 3RGIIQTX]MXGERRSXFIVIYWIH
Do not try to repair your pen-injector SVTYPPMXETEVX


(MVIGXMSRWJSVYWIJSVQP 4(7TIRMRNIGXSV
*SVGPMRMGEPXVMEPYWI
8VMEP-(22
%TTPMIWXS7IQEKPYXMHI
SJ
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Storage 
Store correctly according to the storage conditions on the label
Further important information 
Never share ]SYVTIRMRNIGXSVSV]SYVRIIHPIW[MXLSXLIVTISTPI
'EVIKMZIVWQYWX be very careful when handling used needles 
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SAP_001.pdf: 
Cover Page for Statistical Analysis Plan 
Sponsor name:
Novo Nordisk A/S
NCT number
NCT02648204
Sponsor trial ID: 
NN9535-4216
Official title of study: 
Efficacy and safety of semaglutide versus dulaglutide as add-
on to metformin in subjects with type 2 diabetes 
Document date:
30 November 2017 




Redacted 
Includes redaction of personal identifiable information only.
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