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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01720446




Registration number
NCT01720446
Ethics application status
Date submitted
29/10/2012
Date registered
2/11/2012
Date last updated
27/06/2019

Titles & IDs
Public title
Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes
Scientific title
A Long-term, Randomised, Double-blind, Placebo-controlled, Multinational, Multi-centre Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN™ 6 - Long-term Outcomes)
Secondary ID [1] 0 0
2012-002839-28
Secondary ID [2] 0 0
NN9535-3744
Universal Trial Number (UTN)
Trial acronym
SUSTAIN™ 6
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

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

Experimental: Semaglutide 0.5 mg -

Experimental: Semaglutide 1.0 mg -

Placebo comparator: Semaglutide placebo 0.5 mg -

Placebo comparator: Semaglutide placebo 1.0 mg -


Treatment: Drugs: semaglutide
Once weekly doses of 0.5 mg semaglutide after an initial dose escalation step of 0.25 mg as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin)

Treatment: Drugs: semaglutide
Once weekly doses of 1.0 mg semaglutide after an initial dose escalation step of 0.25 mg followed by 0.5 mg dose escalation as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin)

Treatment: Drugs: placebo
Once weekly doses volume-matched placebo, as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke
Timepoint [1] 0 0
Time from randomisation up to end of follow-up (scheduled at week 109)
Secondary outcome [1] 0 0
Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Outcome
Timepoint [1] 0 0
Time from randomisation up to end of follow-up (scheduled at week 109)
Secondary outcome [2] 0 0
Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome
Timepoint [2] 0 0
Time from randomisation up to end of follow-up (scheduled at week 109)
Secondary outcome [3] 0 0
Time From Randomisation to First Occurrence of All-cause Death, Non-fatal MI, or Non-fatal Stroke
Timepoint [3] 0 0
Time from randomisation up to end of follow-up (scheduled at week 109)
Secondary outcome [4] 0 0
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Glycosylated Haemoglobin (HbA1c)
Timepoint [4] 0 0
Week 0, up to week 104
Secondary outcome [5] 0 0
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Fasting Plasma Glucose
Timepoint [5] 0 0
Week 0, up to week 104
Secondary outcome [6] 0 0
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Body Weight
Timepoint [6] 0 0
Week 0, up to week 104
Secondary outcome [7] 0 0
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile
Timepoint [7] 0 0
Week 0, up to week 104
Secondary outcome [8] 0 0
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Urinary Albumin to Creatinine Ratio
Timepoint [8] 0 0
Week 0, up to week 104
Secondary outcome [9] 0 0
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs
Timepoint [9] 0 0
Week 0, up to week 104
Secondary outcome [10] 0 0
Incidence During the Trial in Other Treatment Outcomes: Hypoglycaemic Events
Timepoint [10] 0 0
Week 0 - 109
Secondary outcome [11] 0 0
Incidence During the Trial in Other Treatment Outcomes: Adverse Events
Timepoint [11] 0 0
Weeks 0-109
Secondary outcome [12] 0 0
Occurrence During the Trial in Other Treatment Outcomes: Anti-semaglutide Antibodies
Timepoint [12] 0 0
Weeks 0-109
Secondary outcome [13] 0 0
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Patient Reported Outcome (PRO)
Timepoint [13] 0 0
Week 0, up to week 104
Secondary outcome [14] 0 0
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile (Free Fatty Acids)
Timepoint [14] 0 0
Week 0, up to week 104
Secondary outcome [15] 0 0
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs (Pulse Rate)
Timepoint [15] 0 0
Week 0, up to week 104

Eligibility
Key inclusion criteria
- Men and women with type 2 diabetes mellitus - Age above or equal to 50 years at screening and clinical evidence of cardiovascular disease or age above or equal to 60 years at screening and subclinical evidence of cardiovascular disease - Anti-diabetic drug naïve, or treated with one or two oral antidiabetic drug (OADs), or treated with human Neutral Protamin Hagedorn (NPH) insulin or long-acting insulin analogue or pre-mixed insulin, both types of insulin either alone or in combination with one or two OADs - HbA1c above or equal to 7.0% at screening
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Type 1 diabetes mellitus - Use of glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide, or other) or pramlintide within 90 days prior to screening - Use of any dipeptidyl peptidase 4 (DPP-IV) inhibitor within 30 days prior to screening - Treatment with insulin other than basal and pre-mixed insulin within 90 days prior to screening - except for short-term use in connection with intercurrent illness - Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (eg diabetes ketoacidosis) within 90 days prior to screening - History of chronic pancreatitis or idiopathic acute pancreatitis - Acute coronary or cerebro-vascular event within 90 days prior to randomisation - Currently planned coronary, carotid or peripheral artery revascularisation - Chronic heart failure New York Heart Association (NYHA) class IV - Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma - Personal history of non-familial medullary thyroid carcinoma - Screening calcitonin above or equal to 50 ng/L

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 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
21/02/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/03/2016
Sample size
Target
Accrual to date
Final
3297
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Blacktown
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - St Leonards
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Ipswich
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Keswick
Recruitment hospital [5] 0 0
Novo Nordisk Investigational Site - Oaklands Park
Recruitment hospital [6] 0 0
Novo Nordisk Investigational Site - Box Hill
Recruitment hospital [7] 0 0
Novo Nordisk Investigational Site - Fitzroy
Recruitment hospital [8] 0 0
Novo Nordisk Investigational Site - Fremantle
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4305 - Ipswich
Recruitment postcode(s) [4] 0 0
5035 - Keswick
Recruitment postcode(s) [5] 0 0
5046 - Oaklands Park
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3065 - Fitzroy
Recruitment postcode(s) [8] 0 0
6160 - Fremantle
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
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
Country [6] 0 0
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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Indiana
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Kansas
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Kentucky
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Louisiana
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Massachusetts
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Michigan
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Missouri
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Nebraska
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New Hampshire
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New York
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North Carolina
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Oklahoma
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Vermont
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Virginia
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Washington
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Wisconsin
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Algeria
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Annaba
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Algeria
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Oran
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Algeria
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Setif
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Algeria
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Tizi Ouzou
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Argentina
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Caba
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Argentina
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Cordoba
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Mar del Plata
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Morón
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Pleven
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Sofia
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Varna
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Aarhus C
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Hellerup
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Germany
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Elsterwerda
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Essen
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Falkensee
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Freiburg
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Hamburg
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Münster
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Germany
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Oldenburg
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Germany
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Saint Ingbert
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Andhra Pradesh
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Karnataka
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Kerala
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Maharashtra
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New Delhi
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Punjab
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Tamil Nadu
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Holon
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Chieti
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Olbia
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Padova
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Primo Piano Palazzina Ambulato
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Serdang
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Malaysia
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Seremban
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Mexico
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Jalisco
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Mexico
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Morelos
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Mexico
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México, D.F.
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Mexico
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Tamaulipas
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Mexico
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Aguascalientes
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Mexico
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San Luis Potosi
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Poland
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Bialystok
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Lublin
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Warszawa
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Zabrze
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Russian Federation
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Arkhangelsk
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Russian Federation
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Barnaul
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Penza
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Saratov
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Russian Federation
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Yaroslavl
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Almería
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Spain
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Antequera
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Spain
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Pozuelo de Alarcon
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Spain
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Sanlúcar De Barrameda - Cádiz-
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Spain
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Sevilla
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Spain
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Vic (Barcelona)
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Taiwan
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Chiayi City
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Taiwan
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Tainan city
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Thailand
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Bangkok
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Turkey
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Ankara
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Turkey
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Antalya
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Turkey
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Canakkale
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Turkey
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Denizli
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Kocaeli
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United Kingdom
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Aberdeen
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Birmingham
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Leeds
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Liverpool
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Northwood
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Sidcup
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Swansea
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United Kingdom
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Torquay

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
Global Clinical Registry (GCR, 1452)
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results are available at https://clinicaltrials.gov/study/NCT01720446