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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02527200




Registration number
NCT02527200
Ethics application status
Date submitted
17/08/2015
Date registered
18/08/2015

Titles & IDs
Public title
Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome
Scientific title
Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome.
Secondary ID [1] 0 0
2014-004415-37
Secondary ID [2] 0 0
NN8022-4179
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolism and Nutrition Disorder 0 0
Obesity 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Mental Health 0 0 0 0
Learning disabilities

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

Experimental: Liraglutide -

Placebo comparator: Placebo -


Treatment: Drugs: liraglutide
Injected s.c./ subcutaneously (under the skin) This trial consists of a part A and a part B. Part A of the trial is conducted in obese adolescents with PWS. Part B of the trial is conducted in obese children with PWS. Entry into part A and part B of the trial will be sequential.

Treatment: Drugs: placebo
Injected s.c./ subcutaneously (under the skin) This trial consists of a part A and a part B. Part A of the trial is conducted in obese adolescents with PWS. Part B of the trial is conducted in obese children with PWS. Entry into part A and part B of the trial will be sequential.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 16 Weeks
Timepoint [1] 0 0
Week 0, Week 16
Primary outcome [2] 0 0
Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 52 Weeks
Timepoint [2] 0 0
Week 0, Week 52
Secondary outcome [1] 0 0
Percentage of Participants Achieving = 5% Reduction in Baseline BMI at Week 16
Timepoint [1] 0 0
At week 16
Secondary outcome [2] 0 0
Percentage of Participants Achieving = 5% Reduction in Baseline BMI at Week 52
Timepoint [2] 0 0
At week 52
Secondary outcome [3] 0 0
Percentage of Participants Achieving = 10% Reduction in Baseline BMI at Week 16
Timepoint [3] 0 0
At week 16
Secondary outcome [4] 0 0
Percentage of Participants Achieving = 10% Reduction in Baseline BMI at Week 52
Timepoint [4] 0 0
At week 52
Secondary outcome [5] 0 0
Percentage of Participants With no Increase in BMI SDS at Week 16
Timepoint [5] 0 0
At week 16
Secondary outcome [6] 0 0
Percentage of Participants With no Increase in BMI SDS at Week 52
Timepoint [6] 0 0
At week 52
Secondary outcome [7] 0 0
Change in BMI From Baseline at Week 16
Timepoint [7] 0 0
Week 0, week 16
Secondary outcome [8] 0 0
Change in BMI From Baseline at Week 52
Timepoint [8] 0 0
Week 0, week 52
Secondary outcome [9] 0 0
Change in Body Weight (Kilogram (kg)) From Baseline at Week 16
Timepoint [9] 0 0
Week 0, week 16
Secondary outcome [10] 0 0
Change in Body Weight (kg) From Baseline at Week 52
Timepoint [10] 0 0
Week 0, week 52
Secondary outcome [11] 0 0
Change in Body Weight (Pounds (lb)) From Baseline at Week 16
Timepoint [11] 0 0
Week 0, week 16
Secondary outcome [12] 0 0
Change in Body Weight (lb) From Baseline at Week 52
Timepoint [12] 0 0
Week 0, week 52
Secondary outcome [13] 0 0
Change in Body Weight (Percentage [%]) From Baseline at Week 16
Timepoint [13] 0 0
Week 0, week 16
Secondary outcome [14] 0 0
Change in Body Weight (%) From Baseline at Week 52
Timepoint [14] 0 0
Week 0, week 52
Secondary outcome [15] 0 0
Change in Waist Circumference From Baseline at Week 16
Timepoint [15] 0 0
Week 0, week 16
Secondary outcome [16] 0 0
Change in Waist Circumference From Baseline at Week 52
Timepoint [16] 0 0
Week 0, week 52
Secondary outcome [17] 0 0
Change in Waist-to-hip Circumference Ratio From Baseline at Week 16
Timepoint [17] 0 0
Week 0, week 16
Secondary outcome [18] 0 0
Change in Waist-to-hip Circumference Ratio From Baseline at Week 52
Timepoint [18] 0 0
Week 0, week 52
Secondary outcome [19] 0 0
Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16
Timepoint [19] 0 0
Week 0, week 16
Secondary outcome [20] 0 0
Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52
Timepoint [20] 0 0
Week 0, week 52
Secondary outcome [21] 0 0
Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 16
Timepoint [21] 0 0
Week 0, week 16
Secondary outcome [22] 0 0
Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 52
Timepoint [22] 0 0
Week 0, week 52
Secondary outcome [23] 0 0
Change in Total Cholesterol From Baseline at Week 16
Timepoint [23] 0 0
Week 0, week 16
Secondary outcome [24] 0 0
Change in Total Cholesterol From Baseline at Week 52
Timepoint [24] 0 0
Week 0, week 52
Secondary outcome [25] 0 0
Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 16
Timepoint [25] 0 0
Week 0, week 16
Secondary outcome [26] 0 0
Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 52
Timepoint [26] 0 0
Week 0, week 52
Secondary outcome [27] 0 0
Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 16
Timepoint [27] 0 0
Week 0, week 16
Secondary outcome [28] 0 0
Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 52
Timepoint [28] 0 0
Week 0, week 52
Secondary outcome [29] 0 0
Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 16
Timepoint [29] 0 0
Week 0, week 16
Secondary outcome [30] 0 0
Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 52
Timepoint [30] 0 0
Week 0, week 52
Secondary outcome [31] 0 0
Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 16
Timepoint [31] 0 0
Week 0, week 16
Secondary outcome [32] 0 0
Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 52
Timepoint [32] 0 0
Week 0, week 52
Secondary outcome [33] 0 0
Change in Triglycerides From Baseline at Week 16
Timepoint [33] 0 0
Week 0, week 16
Secondary outcome [34] 0 0
Change in Triglycerides From Baseline at Week 52
Timepoint [34] 0 0
Week 0, week 52
Secondary outcome [35] 0 0
Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 16
Timepoint [35] 0 0
Week 0, week 16
Secondary outcome [36] 0 0
Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 52
Timepoint [36] 0 0
Week 0, week 52
Secondary outcome [37] 0 0
Change in Systolic and Diastolic Blood Pressure From Baseline at Week 16
Timepoint [37] 0 0
Week 0, week 16
Secondary outcome [38] 0 0
Change in Systolic and Diastolic Blood Pressure From Baseline at Week 52
Timepoint [38] 0 0
Week 0, week 52
Secondary outcome [39] 0 0
Change in Glycosylated Haemoglobin (HbA1c) From Baseline at Week 16
Timepoint [39] 0 0
Week 0, week 16
Secondary outcome [40] 0 0
Change in HbA1c From Baseline at Week 52
Timepoint [40] 0 0
Week 0, week 52
Secondary outcome [41] 0 0
Change in Fasting Plasma Glucose (FPG) From Baseline at Week 16
Timepoint [41] 0 0
Week 0, week 16
Secondary outcome [42] 0 0
Change in FPG From Baseline at Week 52
Timepoint [42] 0 0
Week 0, week 52
Secondary outcome [43] 0 0
Change in Fasting Insulin From Baseline at Week 16
Timepoint [43] 0 0
Week 0, week 16
Secondary outcome [44] 0 0
Change in Fasting Insulin From Baseline at Week 52
Timepoint [44] 0 0
Week 0, week 52
Secondary outcome [45] 0 0
Change in Fasting C Peptide From Baseline at Week 16
Timepoint [45] 0 0
Week 0, week 16
Secondary outcome [46] 0 0
Change in Fasting C Peptide From Baseline at Week 52
Timepoint [46] 0 0
Week 0, week 52
Secondary outcome [47] 0 0
Number of Participants in Glycaemic Category at Week 16
Timepoint [47] 0 0
week 16
Secondary outcome [48] 0 0
Number of Participants in Glycaemic Category at Week 52
Timepoint [48] 0 0
Week 52
Secondary outcome [49] 0 0
Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 16
Timepoint [49] 0 0
Week 0, week 16
Secondary outcome [50] 0 0
Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 52
Timepoint [50] 0 0
Week 0, week 52
Secondary outcome [51] 0 0
Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 16
Timepoint [51] 0 0
Week 0, week 16
Secondary outcome [52] 0 0
Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 52
Timepoint [52] 0 0
Week 0, week 52
Secondary outcome [53] 0 0
Number of Treatment Emergent Adverse Events
Timepoint [53] 0 0
From week 0 to week 54
Secondary outcome [54] 0 0
Number of Severe Treatment Emergent Episodes of Hypoglycaemia
Timepoint [54] 0 0
From week 0 to week 54
Secondary outcome [55] 0 0
Number of Blood Glucose Confirmed Symptomatic Episodes of Hypoglycaemia
Timepoint [55] 0 0
From week 0 to week 54
Secondary outcome [56] 0 0
Number of Participants With Occurrence of Anti-liraglutide Antibodies
Timepoint [56] 0 0
From week 0 to week 54
Secondary outcome [57] 0 0
Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16
Timepoint [57] 0 0
Week 0, Week 16
Secondary outcome [58] 0 0
Number of Participants With Change in ECG From Baseline at Week 52
Timepoint [58] 0 0
Week 0, Week 52
Secondary outcome [59] 0 0
Change in Pulse From Baseline at Week 16
Timepoint [59] 0 0
Week 0, week 16
Secondary outcome [60] 0 0
Change in Pulse From Baseline at Week 52
Timepoint [60] 0 0
Week 0, week 52
Secondary outcome [61] 0 0
Change in Haematology: Haemoglobin From Baseline at Week 16
Timepoint [61] 0 0
Week 0, week 16
Secondary outcome [62] 0 0
Change in Haematology: Haemoglobin From Baseline at Week 52
Timepoint [62] 0 0
Week 0, week 52
Secondary outcome [63] 0 0
Change in Haematology: Haematocrit From Baseline at Week 16
Timepoint [63] 0 0
Week 0, week 16
Secondary outcome [64] 0 0
Change in Haematology: Haematocrit From Baseline at Week 52
Timepoint [64] 0 0
Week 0, week 52
Secondary outcome [65] 0 0
Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16
Timepoint [65] 0 0
Week 0, week 16
Secondary outcome [66] 0 0
Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52
Timepoint [66] 0 0
Week 0, week 52
Secondary outcome [67] 0 0
Change in Haematology: Erythrocytes From Baseline at Week 16
Timepoint [67] 0 0
Week 0, week 16
Secondary outcome [68] 0 0
Change in Haematology: Erythrocytes From Baseline at Week 52
Timepoint [68] 0 0
Week 0, week 52
Secondary outcome [69] 0 0
Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 16
Timepoint [69] 0 0
Week 0, week 16
Secondary outcome [70] 0 0
Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 52
Timepoint [70] 0 0
Week 0, week 52
Secondary outcome [71] 0 0
Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16
Timepoint [71] 0 0
Week 0, week 16
Secondary outcome [72] 0 0
Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52
Timepoint [72] 0 0
Week 0, week 52
Secondary outcome [73] 0 0
Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16
Timepoint [73] 0 0
Week 0, week 16
Secondary outcome [74] 0 0
Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52
Timepoint [74] 0 0
Week 0, week 52
Secondary outcome [75] 0 0
Change in Biochemistry: Albumin From Baseline at Week 16
Timepoint [75] 0 0
Week 0, week 16
Secondary outcome [76] 0 0
Change in Biochemistry: Albumin From Baseline at Week 52
Timepoint [76] 0 0
Week 0, week 52
Secondary outcome [77] 0 0
Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 16
Timepoint [77] 0 0
Week 0, week 16
Secondary outcome [78] 0 0
Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 52
Timepoint [78] 0 0
Week 0, week 52
Secondary outcome [79] 0 0
Change in Hormone Level: Calcitonin From Baseline at Week 16
Timepoint [79] 0 0
Week 0, week 16
Secondary outcome [80] 0 0
Change in Hormone Level: Calcitonin From Baseline at Week 52
Timepoint [80] 0 0
Week 0, week 52
Secondary outcome [81] 0 0
Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 16
Timepoint [81] 0 0
Week 0, week 16
Secondary outcome [82] 0 0
Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 52
Timepoint [82] 0 0
Week 0, week 52
Secondary outcome [83] 0 0
Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 16
Timepoint [83] 0 0
Week 0, week 16
Secondary outcome [84] 0 0
Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 52
Timepoint [84] 0 0
Week 0, week 52
Secondary outcome [85] 0 0
Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 16
Timepoint [85] 0 0
Week 0, week 16
Secondary outcome [86] 0 0
Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 52
Timepoint [86] 0 0
Week 0, week 52
Secondary outcome [87] 0 0
Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 16
Timepoint [87] 0 0
Week 0, week 16
Secondary outcome [88] 0 0
Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 52
Timepoint [88] 0 0
Week 0, week 52
Secondary outcome [89] 0 0
Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 16
Timepoint [89] 0 0
Week 0, week 16
Secondary outcome [90] 0 0
Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 52
Timepoint [90] 0 0
Week 0, week 52
Secondary outcome [91] 0 0
Change in Hormone Level: Estradiol (Females) From Baseline at Week 16
Timepoint [91] 0 0
Week 0, week 16
Secondary outcome [92] 0 0
Change in Hormone Level: Estradiol (Females) From Baseline at Week 52
Timepoint [92] 0 0
Week 0, week 52
Secondary outcome [93] 0 0
Change in Hormone Level: Testosterone (Males) From Baseline at Week 16
Timepoint [93] 0 0
Week 0, week 16
Secondary outcome [94] 0 0
Change in Hormone Level: Testosterone (Males) From Baseline at Week 52
Timepoint [94] 0 0
Week 0, week 52
Secondary outcome [95] 0 0
Number of Participants With Change in Pubertal Status From Baseline at Week 16
Timepoint [95] 0 0
Week 0, week 16
Secondary outcome [96] 0 0
Number of Participants With Change in Pubertal Status From Baseline at Week 52
Timepoint [96] 0 0
Week 0, week 52
Secondary outcome [97] 0 0
Number of Participants With Change in Physical Examination From Baseline at Week 16
Timepoint [97] 0 0
Week 0, week 16
Secondary outcome [98] 0 0
Number of Participants With Change in Physical Examination From Baseline at Week 52
Timepoint [98] 0 0
Week 0, week 52
Secondary outcome [99] 0 0
Height Velocity at Week 16
Timepoint [99] 0 0
Week 16
Secondary outcome [100] 0 0
Height Velocity at Week 52
Timepoint [100] 0 0
week 52
Secondary outcome [101] 0 0
Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 16
Timepoint [101] 0 0
Week 0, week 16
Secondary outcome [102] 0 0
Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 52
Timepoint [102] 0 0
Week 0, week 52
Secondary outcome [103] 0 0
Part A: Change in Patient Reported Health Questionnaire-9 (PHQ-9) From Baseline at Week 16
Timepoint [103] 0 0
Week 0, week 16
Secondary outcome [104] 0 0
Part A: Change in Patient Reported Health Questionnaire-9 (PHQ-9) From Baseline at Week 52
Timepoint [104] 0 0
Week 0, week 52

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
* Confirmed diagnosis of PWS (Prader-Willi Syndrome) (by genetic testing)
* Male or female, age at the time of signing informed consent: - Part A: above or equal to 12 years and less than 18 years
* Tanner stage 2-5 pubertal development for part A, and Tanner stage 1 for part B
* BMI (body mass index) corresponding to equal or above 30 kg/m^2 for adults by international cut-off points1 and equal or above the 95th percentile for age and sex (for diagnosis of obesity)
* Stable body weight during the previous 90 days before screening ( below 10 kg self-reported weight change)
* Testing has been performed to evaluate for adrenal insufficiency and documented in medical record
Minimum age
6 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Type 1 diabetes mellitus (T1DM)
* Type 2 diabetes mellitus (T2DM)
* Calcitonin equal or above 50 ng/L
* No change in treatment plan with growth hormone (GH) from randomisation to the end of the open-label period patients on growth hormone to stay on, patients off GH to stay off during this period. Adjustments in doses of growth hormone will be permitted)
* Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroids Carcinoma (MTC)
* History of pancreatitis (acute or chronic)
* Treatment with any medication prescribed for weight loss within 90 days before screening (e.g. orlistat, zonisamide, topiramate/phentermine, lorcaserin, phentermine, bupropion/naltrexone,liraglutide, metformin)
* Untreated adrenal insufficiency
* Suggestive history of, or significant risk of gastroparesis (e.g. marked abdominal bloating post meal, history of vomiting, severe constipation), as judged by the Investigator

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
9/11/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/11/2020
Sample size
Target
Accrual to date
Final
56
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 - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
Canada
State/province [5] 0 0
Alberta
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
France
State/province [7] 0 0
ANGERS cedex 09
Country [8] 0 0
France
State/province [8] 0 0
Bordeaux
Country [9] 0 0
France
State/province [9] 0 0
Brest
Country [10] 0 0
France
State/province [10] 0 0
BRON cedex
Country [11] 0 0
France
State/province [11] 0 0
Haguenau
Country [12] 0 0
France
State/province [12] 0 0
Lille
Country [13] 0 0
France
State/province [13] 0 0
MARSEILLE Cédex 05
Country [14] 0 0
France
State/province [14] 0 0
MONTPELLIER cedex 05
Country [15] 0 0
France
State/province [15] 0 0
Nice
Country [16] 0 0
France
State/province [16] 0 0
Paris
Country [17] 0 0
France
State/province [17] 0 0
Rouen
Country [18] 0 0
France
State/province [18] 0 0
Toulouse cedex 9
Country [19] 0 0
Italy
State/province [19] 0 0
Fiumicino
Country [20] 0 0
Italy
State/province [20] 0 0
Milano
Country [21] 0 0
Italy
State/province [21] 0 0
Padova
Country [22] 0 0
Netherlands
State/province [22] 0 0
Rotterdam
Country [23] 0 0
New Zealand
State/province [23] 0 0
Grafton
Country [24] 0 0
Turkey
State/province [24] 0 0
Ankara
Country [25] 0 0
Turkey
State/province [25] 0 0
Istanbul
Country [26] 0 0
Turkey
State/province [26] 0 0
Samsun
Country [27] 0 0
Turkey
State/province [27] 0 0
Trabzon

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-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

TypeCitations or Other Details
Journal Diene G, Angulo M, Hale PM, Jepsen CH, Hofman PL, ... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT02527200