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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02970942




Registration number
NCT02970942
Ethics application status
Date submitted
18/11/2016
Date registered
22/11/2016

Titles & IDs
Public title
Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.
Scientific title
This Trial is Conducted Globally. The Aim of This Trial is to Investigate Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis
Secondary ID [1] 0 0
2016-000685-39
Secondary ID [2] 0 0
NN9931-4296
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatobiliary Disorders 0 0
Non-alcoholic Steatohepatitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity
Cancer 0 0 0 0
Liver

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

Experimental: Semaglutide 0,1 mg -

Experimental: Semaglutide 0,2 mg -

Experimental: Semaglutide 0,4 mg -

Placebo comparator: Placebo 1 -

Placebo comparator: Placebo 2 -

Placebo comparator: Placebo 3 -


Treatment: Drugs: Semaglutide
Once daily administration of semaglutide subcutaneously (s.c., under the skin) in three different doses (0.1 mg, 0.2 mg and 0.4 mg)

Treatment: Drugs: Placebo
Once daily administration subcutaneously ( s.c., under the skin)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No)
Timepoint [1] 0 0
After 72 weeks
Secondary outcome [1] 0 0
Percentage of Participants With at Least One Stage of Liver Fibrosis Improvement With no Worsening of NASH After 72 Weeks (Yes/No)
Timepoint [1] 0 0
After 72 weeks
Secondary outcome [2] 0 0
Percentage of Participants With Change in Total NAFLD (Non- Alcoholic Fatty Liver Disease) Activity Score (NAS)
Timepoint [2] 0 0
Baseline (week 0), Week 72
Secondary outcome [3] 0 0
Percentage of Participants With Change in Steatosis
Timepoint [3] 0 0
Baseline (week 0), Week 72
Secondary outcome [4] 0 0
Percentage of Participants With Change in Lobular Inflammation
Timepoint [4] 0 0
Baseline (week 0), Week 72
Secondary outcome [5] 0 0
Percentage of Participants With Change in Hepatocyte Ballooning
Timepoint [5] 0 0
Baseline (week 0), Week 72
Secondary outcome [6] 0 0
Percentage of Participants With Change in Fibrosis Stage According to the Kleiner Fibrosis Classification
Timepoint [6] 0 0
Baseline (week 0), Week 72
Secondary outcome [7] 0 0
Percentage of Participants With Change in Activity Component of Steatosis-activity-fibrosis (SAF) Score
Timepoint [7] 0 0
Baseline (week 0), Week 72
Secondary outcome [8] 0 0
Change in Fibrosis-4 Score
Timepoint [8] 0 0
Baseline (week 0), Week 72
Secondary outcome [9] 0 0
Change in NAFLD Fibrosis Score (NFS)
Timepoint [9] 0 0
Baseline (week 0), Week 72
Secondary outcome [10] 0 0
Change in Alanine Aminotransferase (ALT)
Timepoint [10] 0 0
Baseline (week 0), Week 72
Secondary outcome [11] 0 0
Change in Aspartate Aminotransferase (AST)
Timepoint [11] 0 0
Baseline (week 0), Week 72
Secondary outcome [12] 0 0
Change in Gamma Glutamyl Transferase (GGT)
Timepoint [12] 0 0
Baseline (week 0), Week 72
Secondary outcome [13] 0 0
Change in Albumin
Timepoint [13] 0 0
Baseline (week 0), Week 72
Secondary outcome [14] 0 0
Change in International Normalized Ratio (INR)
Timepoint [14] 0 0
Baseline (week 0), Week 72
Secondary outcome [15] 0 0
Change in Enhanced Liver Fibrosis (ELF)
Timepoint [15] 0 0
Baseline (week 0), Week 72
Secondary outcome [16] 0 0
Change in Cytokeratin 18 (CK-18) Fragments
Timepoint [16] 0 0
Baseline (week 0), Week 72
Secondary outcome [17] 0 0
Change in microRNA 122 (miR-122)
Timepoint [17] 0 0
Baseline (week 0), Week 72
Secondary outcome [18] 0 0
Change in Interleukin-1 Receptor (IL-1R) Antagonist
Timepoint [18] 0 0
Baseline (week 0), Week 72
Secondary outcome [19] 0 0
Change in Monocyte Chemoattractant Protein 1 (MCP-1)
Timepoint [19] 0 0
Baseline (week 0), Week 72
Secondary outcome [20] 0 0
Change in Fibroblast Growth Factor 21 (FGF-21)
Timepoint [20] 0 0
Baseline (week 0), Week 72
Secondary outcome [21] 0 0
Change in Liver Stiffness Assessed by FibroScan®
Timepoint [21] 0 0
Baseline (week 0), Week 72
Secondary outcome [22] 0 0
Change in Liver Steatosis Assessed by FibroScan®
Timepoint [22] 0 0
Baseline (week 0), Week 72
Secondary outcome [23] 0 0
Percentage of Participants With Weight Loss of = 5% of Baseline Body Weight at 72 Weeks (Yes/No)
Timepoint [23] 0 0
Week 72
Secondary outcome [24] 0 0
Percentage of Participants With Weight Loss of = 10% of Baseline Body Weight at 72 Weeks (Yes/No)
Timepoint [24] 0 0
Week 72
Secondary outcome [25] 0 0
Change in Body Weight
Timepoint [25] 0 0
Baseline (week 0), Week 72
Secondary outcome [26] 0 0
Change in Waist Circumference
Timepoint [26] 0 0
Baseline (week 0), Week 72
Secondary outcome [27] 0 0
Change in Body Mass Index (BMI)
Timepoint [27] 0 0
Baseline (week 0), Week 72
Secondary outcome [28] 0 0
Change in Glycosylated Haemoglobin (HbA1c) (%-Point)
Timepoint [28] 0 0
Baseline (week 0), Week 72
Secondary outcome [29] 0 0
Change in HbA1c (Millimoles Per Mole)
Timepoint [29] 0 0
Baseline (week 0), Week 72
Secondary outcome [30] 0 0
Change in Fasting Plasma Glucose (FPG)
Timepoint [30] 0 0
Baseline (week 0), Week 72
Secondary outcome [31] 0 0
Change in Fasting Glucagon
Timepoint [31] 0 0
Baseline (week 0), Week 72
Secondary outcome [32] 0 0
Change in Homeostatic Model Assessment - Insulin Resistance (HOMA-IR)
Timepoint [32] 0 0
Baseline (week 0), Week 72
Secondary outcome [33] 0 0
Change in Diastolic Blood Pressure (DBP)
Timepoint [33] 0 0
Baseline (week 0), Week 72
Secondary outcome [34] 0 0
Change in Systolic Blood Pressure (SBP)
Timepoint [34] 0 0
Baseline (week 0), Week 72
Secondary outcome [35] 0 0
Change in Total Cholesterol
Timepoint [35] 0 0
Baseline (week 0), Week 72
Secondary outcome [36] 0 0
Change in Low Density Lipoprotein (LDL) Cholesterol
Timepoint [36] 0 0
Baseline (week 0), Week 72
Secondary outcome [37] 0 0
Change in High Density Lipoprotein (HDL) Cholesterol
Timepoint [37] 0 0
Baseline (week 0), Week 72
Secondary outcome [38] 0 0
Change in Very Low Density Lipoprotein (VLDL) Cholesterol
Timepoint [38] 0 0
Baseline (week 0), Week 72
Secondary outcome [39] 0 0
Change in Triglycerides
Timepoint [39] 0 0
Baseline (week 0), Week 72
Secondary outcome [40] 0 0
Change in Free Fatty Acids
Timepoint [40] 0 0
Baseline (week 0), Week 72
Secondary outcome [41] 0 0
Change in High Sensitivity C-reactive Protein (hsCRP)
Timepoint [41] 0 0
Baseline (week 0), Week 72
Secondary outcome [42] 0 0
Change in Short Form 36 (SF-36) Score
Timepoint [42] 0 0
Baseline (week 0), Week 72
Secondary outcome [43] 0 0
Number of Treatment-emergent Adverse Events (TEAEs)
Timepoint [43] 0 0
From week 0 to week 79
Secondary outcome [44] 0 0
Number of Treatment-emergent Hypoglycaemic Episodes
Timepoint [44] 0 0
From week 0 to week 79
Secondary outcome [45] 0 0
Number of Treatment-emergent Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemic Episodes
Timepoint [45] 0 0
From week 0 to week 79
Secondary outcome [46] 0 0
Number of Treatment-emergent Severe Hypoglycaemic Episodes
Timepoint [46] 0 0
From week 0 to week 79
Secondary outcome [47] 0 0
Number of Participants Discontinuing Treatment Due to Gastrointestinal Adverse Events
Timepoint [47] 0 0
From week 0 to week 79
Secondary outcome [48] 0 0
Number of Participants With Occurrence of Anti-semaglutide Antibodies During and After 72 Weeks Treatment (Yes/No)
Timepoint [48] 0 0
From week 0 to week 79
Secondary outcome [49] 0 0
Number of Participants With Anti-semaglutide Antibodies With in Vitro Neutralising Effect During and After 72 Weeks Treatment (Yes/No)
Timepoint [49] 0 0
From week 0 to week 79
Secondary outcome [50] 0 0
Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 During and After 72 Weeks Treatment (Yes/No)
Timepoint [50] 0 0
From week 0 to week 79
Secondary outcome [51] 0 0
Number of Participants With Cross-reacting Anti-semaglutide Binding Antibodies With in Vitro Neutralising Effect to Native GLP-1 During and After 72 Weeks Treatment (Yes/No)
Timepoint [51] 0 0
From week 0 to week 79
Secondary outcome [52] 0 0
Change in Pulse From Baseline to Week 72
Timepoint [52] 0 0
Baseline (week 0), Week 72
Secondary outcome [53] 0 0
Percentage of Participants With Change in Electrocardiogram (ECG)
Timepoint [53] 0 0
Baseline (week 0), Week 72
Secondary outcome [54] 0 0
Percentage of Participants With Change in Physical Examination: Cardiovascular System
Timepoint [54] 0 0
Week -6, week 72
Secondary outcome [55] 0 0
Percentage of Participants With Change in Physical Examination: Central and Peripheral Nervous System
Timepoint [55] 0 0
Week -6, week 72
Secondary outcome [56] 0 0
Percentage of Participants With Change in Physical Examination: Gastrointestinal System Including Mouth
Timepoint [56] 0 0
Week -6, week 72
Secondary outcome [57] 0 0
Percentage of Participants With Change in Physical Examination: General Appearance
Timepoint [57] 0 0
Week -6, week 72
Secondary outcome [58] 0 0
Percentage of Participants With Change in Physical Examination: Head, Ears, Eyes, Nose, Throat, Neck
Timepoint [58] 0 0
Week -6, week 72
Secondary outcome [59] 0 0
Percentage of Participants With Change in Physical Examination: Lymph Node Palpation
Timepoint [59] 0 0
Week -6, week 72
Secondary outcome [60] 0 0
Percentage of Participants With Change in Physical Examination: Musculoskeletal System
Timepoint [60] 0 0
Week -6, week 72
Secondary outcome [61] 0 0
Percentage of Participants With Change in Physical Examination: Respiratory System
Timepoint [61] 0 0
Week -6, week 72
Secondary outcome [62] 0 0
Percentage of Participants With Change in Physical Examination: Skin
Timepoint [62] 0 0
Week -6, week 72
Secondary outcome [63] 0 0
Percentage of Participants With Change in Physical Examination: Thyroid Gland
Timepoint [63] 0 0
Week -6, week 72
Secondary outcome [64] 0 0
Change in Haematocrit
Timepoint [64] 0 0
Baseline (week 0), Week 72
Secondary outcome [65] 0 0
Change in Haemoglobin (g/dL)
Timepoint [65] 0 0
Baseline (week 0), Week 72
Secondary outcome [66] 0 0
Change in Haemoglobin (mmol/L)
Timepoint [66] 0 0
Baseline (week 0), Week 72
Secondary outcome [67] 0 0
Change in Leukocytes
Timepoint [67] 0 0
Baseline (week 0), Week 72
Secondary outcome [68] 0 0
Change in Thrombocytes
Timepoint [68] 0 0
Baseline (week 0), Week 72
Secondary outcome [69] 0 0
Change in Erythrocytes
Timepoint [69] 0 0
Baseline (week 0), Week 72
Secondary outcome [70] 0 0
Change in Creatinine (mg/dL)
Timepoint [70] 0 0
Baseline (week 0), Week 72
Secondary outcome [71] 0 0
Change in Creatinine (Umol/L)
Timepoint [71] 0 0
Baseline (week 0), Week 72
Secondary outcome [72] 0 0
Change in Estimated Glomerular Filtration Rate (eGFR)
Timepoint [72] 0 0
Baseline (week 0), Week 72
Secondary outcome [73] 0 0
Change in Creatine Kinase
Timepoint [73] 0 0
Baseline (week 0), Week 72
Secondary outcome [74] 0 0
Change in Urea
Timepoint [74] 0 0
Baseline (week 0), Week 72
Secondary outcome [75] 0 0
Change in Total Bilirubin (mg/dL)
Timepoint [75] 0 0
Baseline (week 0), Week 72
Secondary outcome [76] 0 0
Change in Total Bilirubin (Umol/L)
Timepoint [76] 0 0
Baseline (week 0), Week 72
Secondary outcome [77] 0 0
Change in Alkaline Phosphatase
Timepoint [77] 0 0
Baseline (week 0), Week 72
Secondary outcome [78] 0 0
Change in Ferritin
Timepoint [78] 0 0
Baseline (week 0), Week 72
Secondary outcome [79] 0 0
Change in Sodium (mEq/L)
Timepoint [79] 0 0
Baseline (week 0), Week 72
Secondary outcome [80] 0 0
Change in Sodium (mmol/L)
Timepoint [80] 0 0
Baseline (week 0), Week 72
Secondary outcome [81] 0 0
Change in Potassium (mEq/L)
Timepoint [81] 0 0
Baseline (week 0), Week 72
Secondary outcome [82] 0 0
Change in Potassium (mmol/L)
Timepoint [82] 0 0
Baseline (week 0), Week 72
Secondary outcome [83] 0 0
Change in Calcium (mg/dL)
Timepoint [83] 0 0
Baseline (week 0), Week 72
Secondary outcome [84] 0 0
Change in Calcium (mmol/L)
Timepoint [84] 0 0
Baseline (week 0), Week 72
Secondary outcome [85] 0 0
Change in Amylase
Timepoint [85] 0 0
Baseline (week 0), Week 72
Secondary outcome [86] 0 0
Change in Lipase
Timepoint [86] 0 0
Baseline (week 0), Week 72
Secondary outcome [87] 0 0
Change in Calcitonin
Timepoint [87] 0 0
Baseline (week 0), Week 72

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 except for protocol described pre-screening activities which require a separate informed consent. - Male or female, aged 18-75 years (both inclusive) (for Japan: male or female aged 20-75 years (both inclusive)) at the time of signing informed consent - Local histological diagnosis of NASH followed by histological confirmation of NASH based on central pathologist evaluation of a liver biopsy obtained up to 21 weeks before screening - Histologic evidence of NASH based on central pathologist evaluation of a liver biopsy obtained up to 21 weeks before screening. - NASH fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system based on central pathologist evaluation
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Known or suspected abuse of alcohol (above 20 g/day for women or above 30 g/day for men), alcohol dependence* or narcotics. (* = assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)) - Diagnosis of type 1 diabetes according to medical records - HbA1c above 10% at screening - History or presence of pancreatitis (acute or chronic) - Calcitonin equal or above 50 ng/L at screening - Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative - Body Mass Index (BMI) = 25.0 kg/sqm at the screening visit (visit 1) - Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)

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 2
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
30/11/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/03/2020
Sample size
Target
Accrual to date
Final
320
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Camperdown
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Kingswood
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Westmead
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Box Hill
Recruitment hospital [5] 0 0
Novo Nordisk Investigational Site - Fitzroy
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
Nevada
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Vermont
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
Austria
State/province [18] 0 0
Graz
Country [19] 0 0
Austria
State/province [19] 0 0
Salzburg
Country [20] 0 0
Austria
State/province [20] 0 0
Wien
Country [21] 0 0
Belgium
State/province [21] 0 0
Bruxelles
Country [22] 0 0
Belgium
State/province [22] 0 0
Edegem
Country [23] 0 0
Belgium
State/province [23] 0 0
Gent
Country [24] 0 0
Bulgaria
State/province [24] 0 0
Sofia
Country [25] 0 0
Canada
State/province [25] 0 0
Alberta
Country [26] 0 0
Canada
State/province [26] 0 0
Manitoba
Country [27] 0 0
Canada
State/province [27] 0 0
Nova Scotia
Country [28] 0 0
Canada
State/province [28] 0 0
Ontario
Country [29] 0 0
Canada
State/province [29] 0 0
Quebec
Country [30] 0 0
Denmark
State/province [30] 0 0
Aarhus N
Country [31] 0 0
Denmark
State/province [31] 0 0
Hvidovre
Country [32] 0 0
Finland
State/province [32] 0 0
Helsinki
Country [33] 0 0
France
State/province [33] 0 0
Besançon
Country [34] 0 0
France
State/province [34] 0 0
Clermont-Ferrand
Country [35] 0 0
France
State/province [35] 0 0
Lyon Cedex 4
Country [36] 0 0
France
State/province [36] 0 0
MARSEILLE cedex 08
Country [37] 0 0
France
State/province [37] 0 0
Montpellier
Country [38] 0 0
France
State/province [38] 0 0
NICE cedex 3
Country [39] 0 0
France
State/province [39] 0 0
Paris
Country [40] 0 0
France
State/province [40] 0 0
Pessac
Country [41] 0 0
France
State/province [41] 0 0
Toulouse
Country [42] 0 0
France
State/province [42] 0 0
Venissieux
Country [43] 0 0
Greece
State/province [43] 0 0
Athens
Country [44] 0 0
Greece
State/province [44] 0 0
Goudi, Athens
Country [45] 0 0
Greece
State/province [45] 0 0
Larissa
Country [46] 0 0
Greece
State/province [46] 0 0
Thessaloniki
Country [47] 0 0
Japan
State/province [47] 0 0
Asahikawa-shi, Hokkaido
Country [48] 0 0
Japan
State/province [48] 0 0
Fukui-shi, Fukui
Country [49] 0 0
Japan
State/province [49] 0 0
Kamigyo-ku, Kyoto
Country [50] 0 0
Japan
State/province [50] 0 0
Kumamoto-shi, Kumamoto
Country [51] 0 0
Japan
State/province [51] 0 0
Nagakute-shi, Aichi
Country [52] 0 0
Japan
State/province [52] 0 0
Nara-shi, Nara
Country [53] 0 0
Japan
State/province [53] 0 0
Nishinomiya-shi, Hyogo
Country [54] 0 0
Japan
State/province [54] 0 0
Osaka-shi, Osaka
Country [55] 0 0
Japan
State/province [55] 0 0
Otsu-shi, Shiga
Country [56] 0 0
Japan
State/province [56] 0 0
Saga-shi, Saga
Country [57] 0 0
Japan
State/province [57] 0 0
Shimonoseki-shi, Yamaguchi
Country [58] 0 0
Japan
State/province [58] 0 0
Suita-shi, Osaka
Country [59] 0 0
Japan
State/province [59] 0 0
Takamatsu-shi, Kagawa
Country [60] 0 0
Japan
State/province [60] 0 0
Toyoake-shi, Aichi
Country [61] 0 0
Netherlands
State/province [61] 0 0
Alkmaar
Country [62] 0 0
Netherlands
State/province [62] 0 0
Amstelveen
Country [63] 0 0
Netherlands
State/province [63] 0 0
Amsterdam
Country [64] 0 0
Netherlands
State/province [64] 0 0
Delft
Country [65] 0 0
Netherlands
State/province [65] 0 0
Groningen
Country [66] 0 0
Netherlands
State/province [66] 0 0
Leiden
Country [67] 0 0
Netherlands
State/province [67] 0 0
Maastricht
Country [68] 0 0
Netherlands
State/province [68] 0 0
Nijmegen
Country [69] 0 0
Puerto Rico
State/province [69] 0 0
San Juan
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Barnaul
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Kazan
Country [72] 0 0
Russian Federation
State/province [72] 0 0
Kemerovo
Country [73] 0 0
Russian Federation
State/province [73] 0 0
Krasnoyarsk
Country [74] 0 0
Russian Federation
State/province [74] 0 0
Moscow
Country [75] 0 0
Russian Federation
State/province [75] 0 0
Novosibirsk
Country [76] 0 0
Russian Federation
State/province [76] 0 0
Penza
Country [77] 0 0
Russian Federation
State/province [77] 0 0
Saint-Petersburg
Country [78] 0 0
Russian Federation
State/province [78] 0 0
Saratov
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Stavropol
Country [80] 0 0
Russian Federation
State/province [80] 0 0
Tomsk
Country [81] 0 0
Russian Federation
State/province [81] 0 0
Ulianovsk
Country [82] 0 0
Russian Federation
State/province [82] 0 0
Yoshkar-Ola
Country [83] 0 0
Spain
State/province [83] 0 0
Madrid
Country [84] 0 0
Spain
State/province [84] 0 0
Majadahonda
Country [85] 0 0
Spain
State/province [85] 0 0
Santander
Country [86] 0 0
Spain
State/province [86] 0 0
Santiago de Compostela
Country [87] 0 0
Spain
State/province [87] 0 0
Sevilla
Country [88] 0 0
Spain
State/province [88] 0 0
Valencia
Country [89] 0 0
Sweden
State/province [89] 0 0
Göteborg
Country [90] 0 0
Sweden
State/province [90] 0 0
Malmö
Country [91] 0 0
Sweden
State/province [91] 0 0
Stockholm
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Birmingham
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Bolton
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Cambridge
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Derby
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Dundee
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Edinburgh
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Glasgow
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Hull
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Leeds
Country [101] 0 0
United Kingdom
State/province [101] 0 0
London
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Nottingham
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Portsmouth
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Swansea

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
Address 0 0
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 Novo Nordisk disclosure commitment on novonordisk.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?


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Newsome PN, Buchholtz K, Cusi K, Linder M, Okanoue... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT02970942