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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03574597




Registration number
NCT03574597
Ethics application status
Date submitted
21/06/2018
Date registered
2/07/2018

Titles & IDs
Public title
Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity
Scientific title
SELECT - Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity
Secondary ID [1] 0 0
2017-003380-35
Secondary ID [2] 0 0
EX9536-4388
Universal Trial Number (UTN)
Trial acronym
SELECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight 0 0
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Semaglutide
Treatment: Drugs - Placebo (semaglutide)

Experimental: Semaglutide - Participants will receive semaglutide as an adjunct to standard-of-care. Estimated trial duration for an individual subject is from 31 to 59 months.

Placebo comparator: Placebo (semaglutide) - Participants will receive placebo (semaglutide) as an adjunct to standard-of-care. Estimated trial duration for an individual subject is from 31 to 59 months.


Treatment: Drugs: Semaglutide
Semaglutide will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Subjects will start semaglutide treatment at 0.24 mg; dose will gradually be increased every 4 weeks up to 2.4 mg.

Treatment: Drugs: Placebo (semaglutide)
Placebo will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Participants will receive placebo at an equivalent dose to semaglutide.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Participants From Time of Randomization to First Occurrence of a Composite Outcome Measure Consisting of: Cardiovascular (CV) Death, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke
Timepoint [1] 0 0
From randomisation (week 0) up to 240 weeks
Secondary outcome [1] 0 0
Participants From Time of Randomisation to CV Death
Timepoint [1] 0 0
From randomisation (week 0) up to 240 weeks
Secondary outcome [2] 0 0
Participants From Time of Randomisation to First Occurrence of a Composite Heart Failure (HF) Outcome Measure Consisting of: HF Hospitalisation, Urgent HF Visit or CV Death
Timepoint [2] 0 0
From randomisation (week 0) up to 240 weeks
Secondary outcome [3] 0 0
Participants From Time of Randomisation to All-cause Death
Timepoint [3] 0 0
From randomisation (week 0) up to 240 weeks
Secondary outcome [4] 0 0
Participants From Time of Randomisation to First Occurrence of an Expanded Composite CV Outcome Measure Consisting of: CV Death, Non-fatal MI, Non-fatal Stroke, Coronary Revascularisation or Unstable Angina Pectoris (UAP) Requiring Hospitalisation
Timepoint [4] 0 0
From randomisation (week 0) up to 240 weeks
Secondary outcome [5] 0 0
Participants From Time of Randomisation to First Occurrence of a Composite Outcome Measure Consisting of: All-cause Death, Non-fatal MI, or Non-fatal Stroke
Timepoint [5] 0 0
From randomisation (week 0) up to 240 weeks
Secondary outcome [6] 0 0
Participants From Time of Randomisation to First Occurrence of Non-fatal MI
Timepoint [6] 0 0
From randomisation (week 0) up to 240 weeks
Secondary outcome [7] 0 0
Participants From Time of Randomisation to First Occurrence of Non-fatal Stroke
Timepoint [7] 0 0
From randomisation (week 0) up to 240 weeks
Secondary outcome [8] 0 0
Participants From Time of Randomisation to First Occurrence of Coronary Revascularisation
Timepoint [8] 0 0
From randomisation (week 0) up to 240 weeks
Secondary outcome [9] 0 0
Participants From Time of Randomisation to First Occurrence of UAP Requiring Hospitalisation
Timepoint [9] 0 0
From randomisation (week 0) up to 240 weeks
Secondary outcome [10] 0 0
Participants From Time of Randomisation to First Occurrence of HF Requiring Hospitalisation or Urgent HF Visit
Timepoint [10] 0 0
From randomisation (week 0) up to 240 weeks
Secondary outcome [11] 0 0
Participants From Time of Randomisation to First Occurrence of Glycosylated Haemoglobin (HbA1c) Greater Than Equals to (=) 48 Millimole Per Mole (mmol/Mol) (6.5 Percentage [%])
Timepoint [11] 0 0
From randomisation (week 0) up to 240 weeks
Secondary outcome [12] 0 0
Participants From Time of Randomisation to First Occurrence of a 5-component Composite Nephropathy Outcome Measure
Timepoint [12] 0 0
From randomisation (week 0) up to 240 weeks
Secondary outcome [13] 0 0
Participants From Time of Randomisation to HbA1c = 39 mmol/Mol (5.7%) (for Participants With a Screening HbA1c <39 mmol/Mol [5.7%])
Timepoint [13] 0 0
From randomisation (week 0) up to 240 weeks
Secondary outcome [14] 0 0
Participants With HbA1c < 39 mmol/Mol (5.7%) (for Participants With a Screening HbA1c = 39 mmol/Mol [5.7%])
Timepoint [14] 0 0
At week 52, week 104
Secondary outcome [15] 0 0
Change in Systolic Blood Pressure (SBP)
Timepoint [15] 0 0
Week 0, week 104
Secondary outcome [16] 0 0
Change in Diastolic Blood Pressure (DBP)
Timepoint [16] 0 0
Week 0, week 104
Secondary outcome [17] 0 0
Change in Pulse
Timepoint [17] 0 0
Week 0, week 104
Secondary outcome [18] 0 0
Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline
Timepoint [18] 0 0
Week 0, week 104
Secondary outcome [19] 0 0
Change in Total Cholesterol - Ratio to Baseline
Timepoint [19] 0 0
Week 0, week 104
Secondary outcome [20] 0 0
Change in High Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline
Timepoint [20] 0 0
Week 0, week 104
Secondary outcome [21] 0 0
Change in Low Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline
Timepoint [21] 0 0
Week 0, week 104
Secondary outcome [22] 0 0
Change in Triglycerides - Ratio to Baseline
Timepoint [22] 0 0
Week 0, week 104
Secondary outcome [23] 0 0
Change in Body Weight
Timepoint [23] 0 0
Week 0, week 104
Secondary outcome [24] 0 0
Change in Waist Circumference
Timepoint [24] 0 0
Week 0, week 104
Secondary outcome [25] 0 0
Change From Randomisation (Week 0) in Participant Reported Outcome (PRO): EuroQol Five Dimensions Five Level Questionnaire (EQ-5D-5L) Index Score to Week 104
Timepoint [25] 0 0
Week 0, week 104
Secondary outcome [26] 0 0
Change From Randomisation (Week 0) in PRO: EuroQol Five Dimensions Visual Analogue Scale (EQ-5D-VAS) to Week 104
Timepoint [26] 0 0
Week 0, week 104
Secondary outcome [27] 0 0
Change in HbA1c - Percentage
Timepoint [27] 0 0
Week 0, week 104
Secondary outcome [28] 0 0
Change in HbA1c - mmol/Mol
Timepoint [28] 0 0
Week 0, week 104

Eligibility
Key inclusion criteria
* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Male or female, age greater than or equal to 45 years at the time of signing informed consent
* Body mass index (BMI) greater than or equal to 27 kg/m^2
* Have established cardiovascular (CV) disease as evidenced by at least one of the following: prior myocardial infarction; prior stroke (ischemic or haemorrhagic stroke); or symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) less than 0.85 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cardiovascular-related:

* Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening
* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
* Presently classified as being in New York Heart Association (NYHA) Class IV heart failure

Glycaemia-related:

* HbA1c greater than or equal to 48 mmol/mol (6.5 %) as measured by the central laboratory at screening
* History of type 1 or type 2 diabetes (history of gestational diabetes is allowed)
* Treatment with glucose-lowering agents within 90 days before screening
* Treatment with any glucagon-like-peptide-1 receptor agonist (GLP-1 RA) within 90 days before screening

General safety:

* History or presence of chronic pancreatitis
* Presence of acute pancreatitis within the past 180 days prior to the day of screening
* Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
* End stage renal disease or chronic or intermittent haemodialysis or peritoneal dialysis
* Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed
* Severe psychiatric disorder which in the investigator's opinion could compromise compliance with the protocol
* Known or suspected hypersensitivity to trial products or related products
* Previous participation in this trial. Participation is defined as randomisation
* Receipt of any investigational medicinal product within 30 days before screening
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
* Any disorder, unwillingness or inability, which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/06/2023
Sample size
Target
Accrual to date
Final
17604
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
The Canberra Hospital_Garran - Garran
Recruitment hospital [2] 0 0
Gosford Hospital - Gosford
Recruitment hospital [3] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
Hunter Diabetes Centre - Merewether
Recruitment hospital [5] 0 0
Advara HeartCare - Milton
Recruitment hospital [6] 0 0
Core Research Centre - Milton
Recruitment hospital [7] 0 0
Cholesterol Care Australia - Wollongabba
Recruitment hospital [8] 0 0
Royal Adelaide Hospital Cardiovascular Clinical Trials - Adelaide
Recruitment hospital [9] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [10] 0 0
Monash Cardiovascular Research Centre - Clayton
Recruitment hospital [11] 0 0
Geelong Cardiology Research Unit - Geelong
Recruitment hospital [12] 0 0
Austin Health, Metabolic Disorders Centre - Heidelberg Heights
Recruitment hospital [13] 0 0
HeartCare WA (Joondalup) - Joondalup
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
2291 - Merewether
Recruitment postcode(s) [5] 0 0
4064 - Milton
Recruitment postcode(s) [6] 0 0
4102 - Wollongabba
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [9] 0 0
3168 - Clayton
Recruitment postcode(s) [10] 0 0
3220 - Geelong
Recruitment postcode(s) [11] 0 0
3081 - Heidelberg Heights
Recruitment postcode(s) [12] 0 0
6027 - Joondalup
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
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California
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Lübeck
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Pirna
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Hungary
State/province [157] 0 0
Csongrád-Csanád
Country [158] 0 0
Hungary
State/province [158] 0 0
Zala Megye
Country [159] 0 0
Hungary
State/province [159] 0 0
Debrecen
Country [160] 0 0
Hungary
State/province [160] 0 0
Gyöngyös
Country [161] 0 0
Hungary
State/province [161] 0 0
Szombathely
Country [162] 0 0
India
State/province [162] 0 0
Andhra Pradesh
Country [163] 0 0
India
State/province [163] 0 0
Delhi
Country [164] 0 0
India
State/province [164] 0 0
Gujarat
Country [165] 0 0
India
State/province [165] 0 0
Haryana
Country [166] 0 0
India
State/province [166] 0 0
Karnataka
Country [167] 0 0
India
State/province [167] 0 0
Maharashtra
Country [168] 0 0
India
State/province [168] 0 0
New Delhi
Country [169] 0 0
India
State/province [169] 0 0
Punjab
Country [170] 0 0
India
State/province [170] 0 0
Rajasthan
Country [171] 0 0
India
State/province [171] 0 0
Tamil Nadu
Country [172] 0 0
India
State/province [172] 0 0
Telangana
Country [173] 0 0
India
State/province [173] 0 0
Telengana
Country [174] 0 0
India
State/province [174] 0 0
Uttar Pradesh
Country [175] 0 0
India
State/province [175] 0 0
West Bengal
Country [176] 0 0
India
State/province [176] 0 0
Bangalore
Country [177] 0 0
Ireland
State/province [177] 0 0
Leinster
Country [178] 0 0
Ireland
State/province [178] 0 0
Dublin
Country [179] 0 0
Ireland
State/province [179] 0 0
Mallow
Country [180] 0 0
Israel
State/province [180] 0 0
Beer Sheva
Country [181] 0 0
Israel
State/province [181] 0 0
Haifa
Country [182] 0 0
Israel
State/province [182] 0 0
Jerusalem
Country [183] 0 0
Israel
State/province [183] 0 0
Kfar Saba
Country [184] 0 0
Israel
State/province [184] 0 0
Nahariya
Country [185] 0 0
Israel
State/province [185] 0 0
Petah-Tikva
Country [186] 0 0
Israel
State/province [186] 0 0
Rehovot
Country [187] 0 0
Israel
State/province [187] 0 0
Tel Aviv
Country [188] 0 0
Israel
State/province [188] 0 0
Tel Hashomer
Country [189] 0 0
Israel
State/province [189] 0 0
Tel-Aviv
Country [190] 0 0
Italy
State/province [190] 0 0
LT
Country [191] 0 0
Italy
State/province [191] 0 0
MI
Country [192] 0 0
Italy
State/province [192] 0 0
RM
Country [193] 0 0
Italy
State/province [193] 0 0
Bergamo
Country [194] 0 0
Italy
State/province [194] 0 0
Bologna
Country [195] 0 0
Italy
State/province [195] 0 0
Catania
Country [196] 0 0
Italy
State/province [196] 0 0
Chieti Scalo
Country [197] 0 0
Italy
State/province [197] 0 0
Como
Country [198] 0 0
Italy
State/province [198] 0 0
Cona - Ferrara
Country [199] 0 0
Italy
State/province [199] 0 0
Firenze
Country [200] 0 0
Italy
State/province [200] 0 0
Genova
Country [201] 0 0
Italy
State/province [201] 0 0
Napoli
Country [202] 0 0
Italy
State/province [202] 0 0
Padova
Country [203] 0 0
Italy
State/province [203] 0 0
Palermo
Country [204] 0 0
Italy
State/province [204] 0 0
Pavia
Country [205] 0 0
Italy
State/province [205] 0 0
Pisa
Country [206] 0 0
Italy
State/province [206] 0 0
Roma
Country [207] 0 0
Italy
State/province [207] 0 0
Rome
Country [208] 0 0
Italy
State/province [208] 0 0
Rozzano (MI)
Country [209] 0 0
Italy
State/province [209] 0 0
San Donato Milanese (MI)
Country [210] 0 0
Italy
State/province [210] 0 0
Savigliano (CN)
Country [211] 0 0
Italy
State/province [211] 0 0
Sesto San Giovanni (MI)
Country [212] 0 0
Italy
State/province [212] 0 0
Siena
Country [213] 0 0
Italy
State/province [213] 0 0
Torino
Country [214] 0 0
Japan
State/province [214] 0 0
Adachi-ku, Tokyo
Country [215] 0 0
Japan
State/province [215] 0 0
Asahikawa, Hokkaido
Country [216] 0 0
Japan
State/province [216] 0 0
Bunkyo-ku, Tokyo
Country [217] 0 0
Japan
State/province [217] 0 0
Chiba
Country [218] 0 0
Japan
State/province [218] 0 0
Chikushino-shi, Fukuoka
Country [219] 0 0
Japan
State/province [219] 0 0
Ehime
Country [220] 0 0
Japan
State/province [220] 0 0
Funabashi-shi, Chiba
Country [221] 0 0
Japan
State/province [221] 0 0
Gifu-city, Gifu
Country [222] 0 0
Japan
State/province [222] 0 0
Hirakata-shi, Osaka
Country [223] 0 0
Japan
State/province [223] 0 0
Hiroshima-shi, Hiroshima
Country [224] 0 0
Japan
State/province [224] 0 0
Kagoshima-shi, Kagoshima
Country [225] 0 0
Japan
State/province [225] 0 0
Kanagawa
Country [226] 0 0
Japan
State/province [226] 0 0
Kasugai-shi, Aichi
Country [227] 0 0
Japan
State/province [227] 0 0
Kawaguchi-shi, Saitama
Country [228] 0 0
Japan
State/province [228] 0 0
Kitakyushu-shi, Fukuoka
Country [229] 0 0
Japan
State/province [229] 0 0
Kochi-shi, Kochi
Country [230] 0 0
Japan
State/province [230] 0 0
Kumamoto-shi, Kumamoto
Country [231] 0 0
Japan
State/province [231] 0 0
Kyoto-shi, Kyoto
Country [232] 0 0
Japan
State/province [232] 0 0
Kyoto-shi,Kyoto
Country [233] 0 0
Japan
State/province [233] 0 0
Kyoto
Country [234] 0 0
Japan
State/province [234] 0 0
Matsuyama-shi, Ehime
Country [235] 0 0
Japan
State/province [235] 0 0
Miyagi
Country [236] 0 0
Japan
State/province [236] 0 0
Moriyama-shi, Shiga
Country [237] 0 0
Japan
State/province [237] 0 0
Nagoya-shi, Aichi
Country [238] 0 0
Japan
State/province [238] 0 0
Naha-shi, Okinawa
Country [239] 0 0
Japan
State/province [239] 0 0
Okawa-shi, Fukuoka
Country [240] 0 0
Japan
State/province [240] 0 0
Okayama-shi, Okayama
Country [241] 0 0
Japan
State/province [241] 0 0
Osaka-city, Osaka
Country [242] 0 0
Japan
State/province [242] 0 0
Osaka
Country [243] 0 0
Japan
State/province [243] 0 0
Saga-shi, Saga
Country [244] 0 0
Japan
State/province [244] 0 0
Sapporo-shi, Hokkaido
Country [245] 0 0
Japan
State/province [245] 0 0
Sendai-shi, Miyagi
Country [246] 0 0
Japan
State/province [246] 0 0
Shinjuku-ku, Tokyo
Country [247] 0 0
Japan
State/province [247] 0 0
Takamatsu-shi, Kagawa
Country [248] 0 0
Japan
State/province [248] 0 0
Takasaki-shi, Gunma
Country [249] 0 0
Japan
State/province [249] 0 0
Tokorozawa-shi, Saitama
Country [250] 0 0
Japan
State/province [250] 0 0
Tokorozawa-shi,Saitama
Country [251] 0 0
Japan
State/province [251] 0 0
Tokyo
Country [252] 0 0
Japan
State/province [252] 0 0
Wako-city, Saitama
Country [253] 0 0
Japan
State/province [253] 0 0
Yanagawa-shi, Fukuoka
Country [254] 0 0
Japan
State/province [254] 0 0
Yokosuka-shi, Kanagawa
Country [255] 0 0
Latvia
State/province [255] 0 0
Daugavpils
Country [256] 0 0
Latvia
State/province [256] 0 0
Liepaja
Country [257] 0 0
Latvia
State/province [257] 0 0
Ogre
Country [258] 0 0
Latvia
State/province [258] 0 0
Riga
Country [259] 0 0
Latvia
State/province [259] 0 0
Ventspils
Country [260] 0 0
Malaysia
State/province [260] 0 0
Kelantan
Country [261] 0 0
Malaysia
State/province [261] 0 0
Pahang
Country [262] 0 0
Malaysia
State/province [262] 0 0
Perak
Country [263] 0 0
Malaysia
State/province [263] 0 0
Sarawak
Country [264] 0 0
Malaysia
State/province [264] 0 0
Selangor
Country [265] 0 0
Malaysia
State/province [265] 0 0
Alor Gajah
Country [266] 0 0
Malaysia
State/province [266] 0 0
Alor Setar
Country [267] 0 0
Malaysia
State/province [267] 0 0
Kota Samarahan
Country [268] 0 0
Malaysia
State/province [268] 0 0
Kuala Lumpur
Country [269] 0 0
Malaysia
State/province [269] 0 0
Kuantan
Country [270] 0 0
Malaysia
State/province [270] 0 0
Putrajaya
Country [271] 0 0
Malaysia
State/province [271] 0 0
Sabah
Country [272] 0 0
Mexico
State/province [272] 0 0
Coahuila
Country [273] 0 0
Mexico
State/province [273] 0 0
Jalisco
Country [274] 0 0
Mexico
State/province [274] 0 0
México, D.F.
Country [275] 0 0
Mexico
State/province [275] 0 0
Nuevo León
Country [276] 0 0
Mexico
State/province [276] 0 0
San Luis Potosi
Country [277] 0 0
Mexico
State/province [277] 0 0
Sinaloa
Country [278] 0 0
Mexico
State/province [278] 0 0
Aguascalientes
Country [279] 0 0
Mexico
State/province [279] 0 0
Durango
Country [280] 0 0
Netherlands
State/province [280] 0 0
Apeldoorn
Country [281] 0 0
Netherlands
State/province [281] 0 0
Breda
Country [282] 0 0
Netherlands
State/province [282] 0 0
Deventer
Country [283] 0 0
Netherlands
State/province [283] 0 0
Groningen
Country [284] 0 0
Netherlands
State/province [284] 0 0
Leeuwarden
Country [285] 0 0
Netherlands
State/province [285] 0 0
Leiderdorp
Country [286] 0 0
Netherlands
State/province [286] 0 0
Roosendaal
Country [287] 0 0
Netherlands
State/province [287] 0 0
Rotterdam
Country [288] 0 0
Netherlands
State/province [288] 0 0
Sneek
Country [289] 0 0
Netherlands
State/province [289] 0 0
Tiel
Country [290] 0 0
Norway
State/province [290] 0 0
Bergen
Country [291] 0 0
Norway
State/province [291] 0 0
Hamar
Country [292] 0 0
Norway
State/province [292] 0 0
Lillehammer
Country [293] 0 0
Norway
State/province [293] 0 0
Nordbyhagen
Country [294] 0 0
Norway
State/province [294] 0 0
Oslo
Country [295] 0 0
Norway
State/province [295] 0 0
Tønsberg
Country [296] 0 0
Norway
State/province [296] 0 0
Ålesund
Country [297] 0 0
Poland
State/province [297] 0 0
Lodzkie
Country [298] 0 0
Poland
State/province [298] 0 0
Lubelskie
Country [299] 0 0
Poland
State/province [299] 0 0
Masovian
Country [300] 0 0
Poland
State/province [300] 0 0
Podlaskie Voivodeship
Country [301] 0 0
Poland
State/province [301] 0 0
Podlaskie
Country [302] 0 0
Poland
State/province [302] 0 0
Pomorskie
Country [303] 0 0
Poland
State/province [303] 0 0
Wielkopolskie Voivodeship
Country [304] 0 0
Poland
State/province [304] 0 0
Gdansk
Country [305] 0 0
Poland
State/province [305] 0 0
Krakow
Country [306] 0 0
Poland
State/province [306] 0 0
Lodz
Country [307] 0 0
Poland
State/province [307] 0 0
Lomza
Country [308] 0 0
Poland
State/province [308] 0 0
Lowicz
Country [309] 0 0
Poland
State/province [309] 0 0
Poznan
Country [310] 0 0
Poland
State/province [310] 0 0
Pulawy
Country [311] 0 0
Poland
State/province [311] 0 0
Szczecin
Country [312] 0 0
Poland
State/province [312] 0 0
Warszawa
Country [313] 0 0
Poland
State/province [313] 0 0
Zamosc
Country [314] 0 0
Portugal
State/province [314] 0 0
Almada
Country [315] 0 0
Portugal
State/province [315] 0 0
Coimbra
Country [316] 0 0
Portugal
State/province [316] 0 0
Lisboa
Country [317] 0 0
Portugal
State/province [317] 0 0
Matosinhos
Country [318] 0 0
Portugal
State/province [318] 0 0
Porto
Country [319] 0 0
Puerto Rico
State/province [319] 0 0
Trujillo Alto
Country [320] 0 0
Romania
State/province [320] 0 0
Bihor
Country [321] 0 0
Romania
State/province [321] 0 0
Calaras
Country [322] 0 0
Romania
State/province [322] 0 0
Cluj
Country [323] 0 0
Romania
State/province [323] 0 0
Dolj
Country [324] 0 0
Romania
State/province [324] 0 0
Hunedoara
Country [325] 0 0
Romania
State/province [325] 0 0
Maramures
Country [326] 0 0
Romania
State/province [326] 0 0
Mures
Country [327] 0 0
Romania
State/province [327] 0 0
Timis
Country [328] 0 0
Romania
State/province [328] 0 0
Bacau
Country [329] 0 0
Romania
State/province [329] 0 0
Brasov
Country [330] 0 0
Romania
State/province [330] 0 0
Bucharest
Country [331] 0 0
Romania
State/province [331] 0 0
Bucuresti
Country [332] 0 0
Romania
State/province [332] 0 0
Buzau
Country [333] 0 0
Romania
State/province [333] 0 0
Galati
Country [334] 0 0
Romania
State/province [334] 0 0
Iasi
Country [335] 0 0
Romania
State/province [335] 0 0
Pascani
Country [336] 0 0
Romania
State/province [336] 0 0
Ploiesti
Country [337] 0 0
Romania
State/province [337] 0 0
Satu Mare
Country [338] 0 0
Romania
State/province [338] 0 0
Sibiu
Country [339] 0 0
Russian Federation
State/province [339] 0 0
Russia
Country [340] 0 0
Russian Federation
State/province [340] 0 0
Arkhangelsk
Country [341] 0 0
Russian Federation
State/province [341] 0 0
Barnaul
Country [342] 0 0
Russian Federation
State/province [342] 0 0
Belgorod
Country [343] 0 0
Russian Federation
State/province [343] 0 0
Ekaterinburg
Country [344] 0 0
Russian Federation
State/province [344] 0 0
Ivanovo
Country [345] 0 0
Russian Federation
State/province [345] 0 0
Kazan
Country [346] 0 0
Russian Federation
State/province [346] 0 0
Kemerovo
Country [347] 0 0
Russian Federation
State/province [347] 0 0
Moscow
Country [348] 0 0
Russian Federation
State/province [348] 0 0
Novosibirsk
Country [349] 0 0
Russian Federation
State/province [349] 0 0
Orenburg
Country [350] 0 0
Russian Federation
State/province [350] 0 0
Penza
Country [351] 0 0
Russian Federation
State/province [351] 0 0
Rostov-on-Don
Country [352] 0 0
Russian Federation
State/province [352] 0 0
Saint Petersburg
Country [353] 0 0
Russian Federation
State/province [353] 0 0
Saint-Petersburg, Pushkin
Country [354] 0 0
Russian Federation
State/province [354] 0 0
Saint-Petersburg
Country [355] 0 0
Russian Federation
State/province [355] 0 0
Samara
Country [356] 0 0
Russian Federation
State/province [356] 0 0
Sochi
Country [357] 0 0
Russian Federation
State/province [357] 0 0
St. Petersburg
Country [358] 0 0
Russian Federation
State/province [358] 0 0
Syktyvkar
Country [359] 0 0
Russian Federation
State/province [359] 0 0
Tomsk
Country [360] 0 0
Russian Federation
State/province [360] 0 0
Tumen
Country [361] 0 0
Russian Federation
State/province [361] 0 0
Tver
Country [362] 0 0
Russian Federation
State/province [362] 0 0
Ulianovsk
Country [363] 0 0
Russian Federation
State/province [363] 0 0
Voronezh
Country [364] 0 0
Russian Federation
State/province [364] 0 0
Yaroslavl
Country [365] 0 0
Serbia
State/province [365] 0 0
Vojvodina
Country [366] 0 0
Serbia
State/province [366] 0 0
Belgrade
Country [367] 0 0
South Africa
State/province [367] 0 0
Eastern Cape
Country [368] 0 0
South Africa
State/province [368] 0 0
Free State
Country [369] 0 0
South Africa
State/province [369] 0 0
Gauteng
Country [370] 0 0
South Africa
State/province [370] 0 0
KwaZulu-Natal
Country [371] 0 0
South Africa
State/province [371] 0 0
Western Cape
Country [372] 0 0
Spain
State/province [372] 0 0
Almeria
Country [373] 0 0
Spain
State/province [373] 0 0
La Coruña
Country [374] 0 0
Spain
State/province [374] 0 0
Madrid
Country [375] 0 0
Spain
State/province [375] 0 0
Málaga
Country [376] 0 0
Spain
State/province [376] 0 0
Palma de Mallorca
Country [377] 0 0
Spain
State/province [377] 0 0
Sevilla
Country [378] 0 0
Spain
State/province [378] 0 0
Valencia
Country [379] 0 0
Sweden
State/province [379] 0 0
Göteborg
Country [380] 0 0
Sweden
State/province [380] 0 0
Kristianstad
Country [381] 0 0
Sweden
State/province [381] 0 0
Lund
Country [382] 0 0
Sweden
State/province [382] 0 0
Stockholm
Country [383] 0 0
Sweden
State/province [383] 0 0
Örebro
Country [384] 0 0
Sweden
State/province [384] 0 0
Östersund
Country [385] 0 0
Taiwan
State/province [385] 0 0
Hsinchu City
Country [386] 0 0
Taiwan
State/province [386] 0 0
Kaohsiung City
Country [387] 0 0
Taiwan
State/province [387] 0 0
New Taipei City
Country [388] 0 0
Taiwan
State/province [388] 0 0
Taipei
Country [389] 0 0
Taiwan
State/province [389] 0 0
Taoyuan City
Country [390] 0 0
Thailand
State/province [390] 0 0
Mueang Chiang Mai District
Country [391] 0 0
Thailand
State/province [391] 0 0
Pathumthani
Country [392] 0 0
Thailand
State/province [392] 0 0
Bangkok
Country [393] 0 0
Thailand
State/province [393] 0 0
Chiang Mai
Country [394] 0 0
Thailand
State/province [394] 0 0
Khon kaen
Country [395] 0 0
Turkey
State/province [395] 0 0
Adana
Country [396] 0 0
Turkey
State/province [396] 0 0
Ankara
Country [397] 0 0
Turkey
State/province [397] 0 0
Antalya
Country [398] 0 0
Turkey
State/province [398] 0 0
Aydin
Country [399] 0 0
Turkey
State/province [399] 0 0
Eskisehir
Country [400] 0 0
Turkey
State/province [400] 0 0
Gaziantep
Country [401] 0 0
Turkey
State/province [401] 0 0
Istanbul
Country [402] 0 0
Turkey
State/province [402] 0 0
Izmir
Country [403] 0 0
Turkey
State/province [403] 0 0
Kayseri
Country [404] 0 0
Turkey
State/province [404] 0 0
Mersin
Country [405] 0 0
Turkey
State/province [405] 0 0
Sivas
Country [406] 0 0
Ukraine
State/province [406] 0 0
Chernivtsi
Country [407] 0 0
Ukraine
State/province [407] 0 0
Kharkiv
Country [408] 0 0
Ukraine
State/province [408] 0 0
Kyiv
Country [409] 0 0
Ukraine
State/province [409] 0 0
Lviv
Country [410] 0 0
Ukraine
State/province [410] 0 0
Odesa
Country [411] 0 0
Ukraine
State/province [411] 0 0
Vinnytsia
Country [412] 0 0
Ukraine
State/province [412] 0 0
Zhytomyr
Country [413] 0 0
United Kingdom
State/province [413] 0 0
North Yorkshire
Country [414] 0 0
United Kingdom
State/province [414] 0 0
South Yorkshire
Country [415] 0 0
United Kingdom
State/province [415] 0 0
West Sussex
Country [416] 0 0
United Kingdom
State/province [416] 0 0
Addlestone
Country [417] 0 0
United Kingdom
State/province [417] 0 0
Airdrie
Country [418] 0 0
United Kingdom
State/province [418] 0 0
Antrim
Country [419] 0 0
United Kingdom
State/province [419] 0 0
Axbridge
Country [420] 0 0
United Kingdom
State/province [420] 0 0
Basingstoke
Country [421] 0 0
United Kingdom
State/province [421] 0 0
Bexhill-on-Sea
Country [422] 0 0
United Kingdom
State/province [422] 0 0
Birmingham
Country [423] 0 0
United Kingdom
State/province [423] 0 0
Blackpool
Country [424] 0 0
United Kingdom
State/province [424] 0 0
Bollington
Country [425] 0 0
United Kingdom
State/province [425] 0 0
Bradford-on-Avon
Country [426] 0 0
United Kingdom
State/province [426] 0 0
Bristol
Country [427] 0 0
United Kingdom
State/province [427] 0 0
Cardiff
Country [428] 0 0
United Kingdom
State/province [428] 0 0
Chertsey
Country [429] 0 0
United Kingdom
State/province [429] 0 0
Chester
Country [430] 0 0
United Kingdom
State/province [430] 0 0
Coventry
Country [431] 0 0
United Kingdom
State/province [431] 0 0
Dundee
Country [432] 0 0
United Kingdom
State/province [432] 0 0
Exeter
Country [433] 0 0
United Kingdom
State/province [433] 0 0
Harrow
Country [434] 0 0
United Kingdom
State/province [434] 0 0
High Wycombe
Country [435] 0 0
United Kingdom
State/province [435] 0 0
Hull
Country [436] 0 0
United Kingdom
State/province [436] 0 0
Leicester
Country [437] 0 0
United Kingdom
State/province [437] 0 0
Lincoln
Country [438] 0 0
United Kingdom
State/province [438] 0 0
Liverpool
Country [439] 0 0
United Kingdom
State/province [439] 0 0
London
Country [440] 0 0
United Kingdom
State/province [440] 0 0
Manchester
Country [441] 0 0
United Kingdom
State/province [441] 0 0
Middlesbrough
Country [442] 0 0
United Kingdom
State/province [442] 0 0
Plymouth
Country [443] 0 0
United Kingdom
State/province [443] 0 0
Rhyl
Country [444] 0 0
United Kingdom
State/province [444] 0 0
Sandbach
Country [445] 0 0
United Kingdom
State/province [445] 0 0
Somerset
Country [446] 0 0
United Kingdom
State/province [446] 0 0
Southampton
Country [447] 0 0
United Kingdom
State/province [447] 0 0
Stevenage
Country [448] 0 0
United Kingdom
State/province [448] 0 0
Sunderland
Country [449] 0 0
United Kingdom
State/province [449] 0 0
Taunton
Country [450] 0 0
United Kingdom
State/province [450] 0 0
Torquay
Country [451] 0 0
United Kingdom
State/province [451] 0 0
Truro
Country [452] 0 0
United Kingdom
State/province [452] 0 0
Wishaw

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Transparency (dept.2834)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://novonordisk-trials.com


What supporting documents are/will be available?




Results publications and other study-related documents



Results are available at https://clinicaltrials.gov/study/NCT03574597