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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01541215




Registration number
NCT01541215
Ethics application status
Date submitted
23/02/2012
Date registered
29/02/2012

Titles & IDs
Public title
Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes
Scientific title
Efficacy and Safety of Liraglutide in Combination With Metformin Versus Metformin Monotherapy on Glycaemic Control in Children and Adolescents With Type 2 Diabetes
Secondary ID [1] 0 0
2011-002605-29
Secondary ID [2] 0 0
NN2211-3659
Universal Trial Number (UTN)
Trial acronym
Ellipse™
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 - liraglutide
Treatment: Drugs - placebo
Treatment: Drugs - metformin

Experimental: Lira + Met -

Placebo comparator: Placebo + Met -


Treatment: Drugs: liraglutide
Administered subcutaneously (s.c., under the skin) once daily.1.8 mg or maximum tolerated dose (MTD: 0.6 mg, 1.2 mg, 1.8 mg) for 26 weeks. Subjects will continue treatment in a 26 week open-labelled extension. Rescue treatment will be allowed if rescue criteria are met.

Treatment: Drugs: placebo
Administered subcutaneously (s.c., under the skin) once daily for 26 weeks. Subjects will discontinue placebo treatment in the open-labelled extension. Rescue treatment will be allowed if rescue criteria are met.

Treatment: Drugs: metformin
Tablets administered for 26 weeks. Maximum tolerated dose (MTD) between 1000-2000 mg at the discretion of the investigator. Subjects will continue treatment in a 26 week open-labelled extension.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in HbA1c (Glycosylated Haemoglobin)
Timepoint [1] 0 0
Week 0, week 26
Secondary outcome [1] 0 0
Change From Baseline in Fasting Plasma Glucose (FPG)
Timepoint [1] 0 0
Week 0, week 26
Secondary outcome [2] 0 0
Number of Subjects Having HbA1c Below 7.0%
Timepoint [2] 0 0
Week 26
Secondary outcome [3] 0 0
Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS)
Timepoint [3] 0 0
Week 0, week 26
Secondary outcome [4] 0 0
Number of Subjects Having HbA1c Below 7.0%
Timepoint [4] 0 0
Week 52
Secondary outcome [5] 0 0
Number of Subjects Having HbA1c Maximum 6.5%
Timepoint [5] 0 0
Week 26
Secondary outcome [6] 0 0
Number of Subjects Having HbA1c Maximum 6.5%
Timepoint [6] 0 0
Week 52
Secondary outcome [7] 0 0
Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes
Timepoint [7] 0 0
Week 26
Secondary outcome [8] 0 0
Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes
Timepoint [8] 0 0
Week 52
Secondary outcome [9] 0 0
Number of Subjects Having HbA1c Below 7.5%
Timepoint [9] 0 0
Week 26
Secondary outcome [10] 0 0
Number of Subjects Having HbA1c Below 7.5%
Timepoint [10] 0 0
Week 52
Secondary outcome [11] 0 0
Change in HbA1c
Timepoint [11] 0 0
Week 0, week 52
Secondary outcome [12] 0 0
Change in FPG
Timepoint [12] 0 0
Week 0, week 52
Secondary outcome [13] 0 0
Change in Mean 7-point Self-measured Plasma Glucose
Timepoint [13] 0 0
Week 0, week 26
Secondary outcome [14] 0 0
Change From Baseline in 7-point Self-measured Plasma Glucose
Timepoint [14] 0 0
Week 0, week 52
Secondary outcome [15] 0 0
Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)
Timepoint [15] 0 0
Week 0, week 26
Secondary outcome [16] 0 0
Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)
Timepoint [16] 0 0
Week 0, week 52
Secondary outcome [17] 0 0
Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)
Timepoint [17] 0 0
Week 0, week 26
Secondary outcome [18] 0 0
Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)
Timepoint [18] 0 0
Week 0, week 52
Secondary outcome [19] 0 0
Change From Baseline in Body Weight
Timepoint [19] 0 0
Week 0, week 26
Secondary outcome [20] 0 0
Change From Baseline in Body Weight
Timepoint [20] 0 0
Week 0, week 52
Secondary outcome [21] 0 0
Change From Baseline in BMI Standard Deviation Score (SDS)
Timepoint [21] 0 0
Week 0, week 52
Secondary outcome [22] 0 0
Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
Timepoint [22] 0 0
Week 0, week 26
Secondary outcome [23] 0 0
Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
Timepoint [23] 0 0
Week 0, week 52
Secondary outcome [24] 0 0
Ratio to Baseline: Fasting Insulin
Timepoint [24] 0 0
Week 0, week 26
Secondary outcome [25] 0 0
Ratio to Baseline: Fasting Insulin
Timepoint [25] 0 0
Week 0, week 52
Secondary outcome [26] 0 0
Ratio to Baseline: Fasting Pro-insulin
Timepoint [26] 0 0
Week 0, week 26
Secondary outcome [27] 0 0
Ratio to Baseline: Fasting Pro-insulin
Timepoint [27] 0 0
Week 0, week 52
Secondary outcome [28] 0 0
Ratio to Baseline: Pro-insulin/Insulin Ratio
Timepoint [28] 0 0
Week 0, week 26
Secondary outcome [29] 0 0
Ratio to Baseline: Pro-insulin/Insulin Ratio
Timepoint [29] 0 0
Week 0, week 52
Secondary outcome [30] 0 0
Ratio to Baseline: Fasting Glucagon
Timepoint [30] 0 0
Week 0, week 26
Secondary outcome [31] 0 0
Ratio to Baseline: Fasting Glucagon
Timepoint [31] 0 0
Week 0, week 52
Secondary outcome [32] 0 0
Ratio to Baseline: Fasting C-peptide
Timepoint [32] 0 0
Week 0, week 26
Secondary outcome [33] 0 0
Ratio to Baseline: Fasting C-peptide
Timepoint [33] 0 0
Week 0, week 52
Secondary outcome [34] 0 0
Ratio to Baseline: Homeostasis Model Assessment of Beta-cell Function (HOMA-B)
Timepoint [34] 0 0
Week 0, week 26
Secondary outcome [35] 0 0
Ratio to Baseline: HOMA-B
Timepoint [35] 0 0
Week 0, week 52
Secondary outcome [36] 0 0
Ratio to Baseline: Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)
Timepoint [36] 0 0
Week 0, week 26
Secondary outcome [37] 0 0
Ratio to Baseline: HOMA-IR
Timepoint [37] 0 0
Week 0, week 52
Secondary outcome [38] 0 0
Ratio to Baseline: Total Cholesterol
Timepoint [38] 0 0
Week 0, week 26
Secondary outcome [39] 0 0
Ratio to Baseline: Total Cholesterol
Timepoint [39] 0 0
Week 0, week 52
Secondary outcome [40] 0 0
Ratio to Baseline: Low Density Lipoprotein (LDL) Cholesterol
Timepoint [40] 0 0
Week 0, week 26
Secondary outcome [41] 0 0
Ratio to Baseline: LDL Cholesterol
Timepoint [41] 0 0
Week 0, week 52
Secondary outcome [42] 0 0
Ratio to Baseline: Very Low-density Lipoprotein (VLDL) Cholesterol
Timepoint [42] 0 0
Week 0, week 26
Secondary outcome [43] 0 0
Ratio to Baseline: VLDL Cholesterol
Timepoint [43] 0 0
Week 0, week 52
Secondary outcome [44] 0 0
Ratio to Baseline: High-density Lipoprotein (HDL) Cholesterol
Timepoint [44] 0 0
Week 0, week 26
Secondary outcome [45] 0 0
Ratio to Baseline: HDL Cholesterol
Timepoint [45] 0 0
Week 0, week 52
Secondary outcome [46] 0 0
Ratio to Baseline: Triglycerides
Timepoint [46] 0 0
Week 0, week 26
Secondary outcome [47] 0 0
Ratio to Baseline: Triglycerides
Timepoint [47] 0 0
Week 0, week 52
Secondary outcome [48] 0 0
Ratio to Baseline: Free Fatty Acids
Timepoint [48] 0 0
Week 0, week 26
Secondary outcome [49] 0 0
Ratio to Baseline: Free Fatty Acids
Timepoint [49] 0 0
Week 0, week 52
Secondary outcome [50] 0 0
Change From Baseline in Pulse
Timepoint [50] 0 0
Week 0, week 26
Secondary outcome [51] 0 0
Change From Baseline in Pulse
Timepoint [51] 0 0
Week 0, week 52
Secondary outcome [52] 0 0
Change From Baseline in Height SDS
Timepoint [52] 0 0
Week 0, week 26
Secondary outcome [53] 0 0
Change From Baseline in Height SDS
Timepoint [53] 0 0
Week 0, week 52
Secondary outcome [54] 0 0
Change in Bone Age Assessment (X-ray of Left Hand and Wrist)
Timepoint [54] 0 0
Week 0, week 52
Secondary outcome [55] 0 0
Pubertal Assessment/Progression (Tanner Staging)
Timepoint [55] 0 0
Week 0, week 26, week 52
Secondary outcome [56] 0 0
Growth (Height Velocity)
Timepoint [56] 0 0
Week 0, week 26
Secondary outcome [57] 0 0
Growth (Height Velocity)
Timepoint [57] 0 0
Week 0, week 52
Secondary outcome [58] 0 0
Height Velocity SDS
Timepoint [58] 0 0
Week 0, week 26
Secondary outcome [59] 0 0
Height Velocity SDS
Timepoint [59] 0 0
Week 0, week 52
Secondary outcome [60] 0 0
Number of Hypoglycaemic Episodes
Timepoint [60] 0 0
0-26 weeks
Secondary outcome [61] 0 0
Number of Hypoglycaemic Episodes
Timepoint [61] 0 0
0-52 weeks
Secondary outcome [62] 0 0
Number of Adverse Events (Week 0-26)
Timepoint [62] 0 0
0-26 weeks
Secondary outcome [63] 0 0
Number of Adverse Events (Week 0-52)
Timepoint [63] 0 0
0-52 weeks
Secondary outcome [64] 0 0
Number of Serious Adverse Events (Week 0-26)
Timepoint [64] 0 0
0-26 weeks
Secondary outcome [65] 0 0
Number of Serious Adverse Events (Week 0-52)
Timepoint [65] 0 0
0-52 weeks
Secondary outcome [66] 0 0
Number of Adverse Events (Week 53-104)
Timepoint [66] 0 0
Week 53-104
Secondary outcome [67] 0 0
Number of Serious Adverse Events (Week 53-104)
Timepoint [67] 0 0
Weeks 53-104
Secondary outcome [68] 0 0
Growth (Height Velocity)- Week 104
Timepoint [68] 0 0
Week 0, week 104
Secondary outcome [69] 0 0
Height Velocity SDS- Week 104
Timepoint [69] 0 0
Week 0, week 104
Secondary outcome [70] 0 0
Change From Week 52 in Height SDS- Week 104
Timepoint [70] 0 0
Week 52, week 104
Secondary outcome [71] 0 0
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104
Timepoint [71] 0 0
Week 52, week 104
Secondary outcome [72] 0 0
Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 104
Timepoint [72] 0 0
Week 52, week 104
Secondary outcome [73] 0 0
Number of Adverse Events (Week 53-156)
Timepoint [73] 0 0
Week 53-156
Secondary outcome [74] 0 0
Number of Serious Adverse Events (Week 53-156)
Timepoint [74] 0 0
Weeks 53-156
Secondary outcome [75] 0 0
Growth (Height Velocity)- Week 156
Timepoint [75] 0 0
Week 0, week 156
Secondary outcome [76] 0 0
Height Velocity SDS- Week 156
Timepoint [76] 0 0
Week 0, week 156
Secondary outcome [77] 0 0
Change From Week 52 in Height SDS- Week 156
Timepoint [77] 0 0
Week 52, week 156
Secondary outcome [78] 0 0
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156
Timepoint [78] 0 0
Week 52, week 156
Secondary outcome [79] 0 0
Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 156
Timepoint [79] 0 0
Week 52, week 156

Eligibility
Key inclusion criteria
- Children and adolescents between the ages of 10-16 years. Subjects cannot turn 17 years and 11 months before the end of treatment (52 weeks) - Diagnosis of type 2 diabetes mellitus and treated for at least 30 days with: diet and exercise alone, diet and exercise in combination with metformin monotherapy, diet and exercise in combination with metformin and a stable (Stable is defined as basal insulin adjustments up to 15%) dose of basal insulin, diet and exercise in combination with a stable (Stable is defined as basal insulin adjustments up to 15%) dose of basal insulin - HbA1c: 7.0-11% (inclusive) if diet and exercise treated or 6.5-11% (inclusive) if treated with metformin as monotherapy, basal insulin as monotherapy or metformin and basal insulin in combination - Body mass index (BMI) above 85% percentile of the general age and gender matched population
Minimum age
10 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Type 1 diabetes - Maturity onset diabetes of the young (MODY) - Use of any antidiabetic agent other than metformin and/or basal insulin within 90 days prior to screening - Recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator - History of chronic pancreatitis or idiopathic acute pancreatitis - Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator's opinion could interfere with results of the trial - Uncontrolled hypertension, treated or untreated above 99th percentile for age and gender in children - Known or suspected abuse of alcohol or drugs/narcotics

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
13/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/05/2020
Sample size
Target
Accrual to date
Final
135
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Ipswich
Recruitment postcode(s) [1] 0 0
4305 - Ipswich
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
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Delaware
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Nevada
Country [19] 0 0
United States of America
State/province [19] 0 0
New Jersey
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
Country [21] 0 0
United States of America
State/province [21] 0 0
Ohio
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
South Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
South Dakota
Country [25] 0 0
United States of America
State/province [25] 0 0
Tennessee
Country [26] 0 0
United States of America
State/province [26] 0 0
Texas
Country [27] 0 0
United States of America
State/province [27] 0 0
Virginia
Country [28] 0 0
United States of America
State/province [28] 0 0
West Virginia
Country [29] 0 0
Austria
State/province [29] 0 0
Graz
Country [30] 0 0
Austria
State/province [30] 0 0
Innsbruck
Country [31] 0 0
Austria
State/province [31] 0 0
Salzburg
Country [32] 0 0
Austria
State/province [32] 0 0
Wels
Country [33] 0 0
Belgium
State/province [33] 0 0
Brussel
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Belgium
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Bruxelles
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Belgium
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Leuven
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Brazil
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Rio Grande Do Sul
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Canada
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Alberta
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Canada
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Manitoba
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Canada
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Ontario
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Canada
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Quebec
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Croatia
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Rijeka
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Croatia
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Zagreb
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Herlev
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Denmark
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Næstved
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Egypt
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Alexandria
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Egypt
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Cairo
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Egypt
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France
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Marseille
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France
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MONTPELLIER cedex 05
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Germany
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Ludwigshafen
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Germany
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Mayen
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Greece
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Athens
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Greece
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Goudi/ Athens
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Greece
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Thessaloniki
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Hungary
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Budapest
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Hungary
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Miskolc
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Hungary
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Szombathely
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India
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Andhra Pradesh
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India
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Karnataka
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India
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Maharashtra
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India
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New Delhi
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India
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Punjab
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India
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Rajasthan
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India
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Tamil Nadu
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India
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Telengana
Country [66] 0 0
India
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West Bengal
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India
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Kolkata
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Israel
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Beer Sheva
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Haifa
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Jerusalem
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Petah Tikva
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Israel
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Tel Hashomer
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Italy
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Roma
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Hazmieh
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Lebanon
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Lebanon - Beirut
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Malaysia
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Kuala Lumpur
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Mexico
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Tamaulipas
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Mexico
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Puebla
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Morocco
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Fès
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Morocco
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Rabat
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Netherlands
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Den Bosch
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Grafton
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North Macedonia
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Skopje
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Norway
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Bergen
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Poland
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Katowice
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Warszawa
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Wroclaw
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Portugal
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Braga
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Portugal
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Lisboa
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Puerto Rico
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Ponce
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Romania
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Timis
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Romania
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Bucharest
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Romania
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Constanta
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Russian Federation
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Chelyabinsk
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Russian Federation
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Izhevsk
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Russian Federation
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Krasnoyarsk
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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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Saint-Petersburg
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Russian Federation
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Saratov
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Russian Federation
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Tomsk
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Serbia
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Belgrade
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Serbia
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Nis
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Serbia
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Novi Sad
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Spain
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Leganés
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Spain
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Madrid
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Spain
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Vigo
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Spain
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Vitoria
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Sweden
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Göteborg
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Sweden
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Huddinge
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Sweden
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Uppsala
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Taiwan
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Tainan city
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Taiwan
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Taoyuan
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Turkey
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Ankara
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Turkey
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Istanbul
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Turkey
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Kocaeli
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United Kingdom
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Birmingham
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Norwich
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United Kingdom
State/province [123] 0 0
Southampton

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 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/sharing-results


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01541215