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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01541215
Other study ID # NN2211-3659
Secondary ID 2011-002605-29P/
Status Completed
Phase Phase 3
First received
Last updated
Start date November 13, 2012
Est. completion date May 20, 2020

Study information

Verified date July 2021
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial is conducted globally. The aim of this trial is to assess the efficacy and safety of liraglutide in the paediatric population in order to potentially address the unmet need for treatment of children and adolescents with type 2 diabetes.


Recruitment information / eligibility

Status Completed
Enrollment 135
Est. completion date May 20, 2020
Est. primary completion date November 15, 2017
Accepts healthy volunteers No
Gender All
Age group 10 Years to 17 Years
Eligibility 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 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


Related Conditions & MeSH terms


Intervention

Drug:
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.
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.
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.

Locations

Country Name City State
Australia Novo Nordisk Investigational Site Ipswich Queensland
Austria Novo Nordisk Investigational Site Graz
Austria Novo Nordisk Investigational Site Innsbruck
Austria Novo Nordisk Investigational Site Salzburg
Austria Novo Nordisk Investigational Site Wels
Belgium Novo Nordisk Investigational Site Brussel
Belgium Novo Nordisk Investigational Site Bruxelles
Belgium Novo Nordisk Investigational Site Leuven
Brazil Novo Nordisk Investigational Site Porto Alegre Rio Grande Do Sul
Canada Novo Nordisk Investigational Site Brampton Ontario
Canada Novo Nordisk Investigational Site Edmonton Alberta
Canada Novo Nordisk Investigational Site Westmount Quebec
Canada Novo Nordisk Investigational Site Winnipeg Manitoba
Croatia Novo Nordisk Investigational Site Rijeka
Croatia Novo Nordisk Investigational Site Zagreb
Denmark Novo Nordisk Investigational Site Herlev
Denmark Novo Nordisk Investigational Site Næstved
Egypt Novo Nordisk Investigational Site Alexandria
Egypt Novo Nordisk Investigational Site Cairo
Egypt Novo Nordisk Investigational Site Cairo
Egypt Novo Nordisk Investigational Site Mansoura
France Novo Nordisk Investigational Site Marseille
France Novo Nordisk Investigational Site MONTPELLIER cedex 05
Germany Novo Nordisk Investigational Site Ludwigshafen
Germany Novo Nordisk Investigational Site Mayen
Greece Novo Nordisk Investigational Site Athens
Greece Novo Nordisk Investigational Site Athens
Greece Novo Nordisk Investigational Site Goudi/ Athens
Greece Novo Nordisk Investigational Site Thessaloniki
Hungary Novo Nordisk Investigational Site Budapest
Hungary Novo Nordisk Investigational Site Budapest
Hungary Novo Nordisk Investigational Site Budapest
Hungary Novo Nordisk Investigational Site Miskolc
Hungary Novo Nordisk Investigational Site Szombathely
India Novo Nordisk Investigational Site Bangalore Karnataka
India Novo Nordisk Investigational Site Bangalore Karnataka
India Novo Nordisk Investigational Site Bangalore Karnataka
India Novo Nordisk Investigational Site Bangalore Karnataka
India Novo Nordisk Investigational Site Chandigarh Punjab
India Novo Nordisk Investigational Site Chennai Tamil Nadu
India Novo Nordisk Investigational Site Guntur Andhra Pradesh
India Novo Nordisk Investigational Site Hyderabad Andhra Pradesh
India Novo Nordisk Investigational Site Hyderbad Telengana
India Novo Nordisk Investigational Site Jaipur Rajasthan
India Novo Nordisk Investigational Site Kolkata West Bengal
India Novo Nordisk Investigational Site Kolkata
India Novo Nordisk Investigational Site Ludhiana Punjab
India Novo Nordisk Investigational Site Mumbai Maharashtra
India Novo Nordisk Investigational Site Mumbai Maharashtra
India Novo Nordisk Investigational Site New Dehli New Delhi
India Novo Nordisk Investigational Site Pune Maharashtra
Israel Novo Nordisk Investigational Site Beer Sheva
Israel Novo Nordisk Investigational Site Haifa
Israel Novo Nordisk Investigational Site Jerusalem
Israel Novo Nordisk Investigational Site Petah Tikva
Israel Novo Nordisk Investigational Site Tel Hashomer
Italy Novo Nordisk Investigational Site Roma
Lebanon Novo Nordisk Investigational Site Hazmieh
Lebanon Novo Nordisk Investigational Site Lebanon - Beirut
Malaysia Novo Nordisk Investigational Site Kuala Lumpur
Mexico Novo Nordisk Investigational Site Puebla
Mexico Novo Nordisk Investigational Site Tampico Tamaulipas
Morocco Novo Nordisk Investigational Site Fès
Morocco Novo Nordisk Investigational Site Rabat
Netherlands Novo Nordisk Investigational Site Den Bosch
New Zealand Novo Nordisk Investigational Site Grafton
North Macedonia Novo Nordisk Investigational Site Skopje
Norway Novo Nordisk Investigational Site Bergen
Poland Novo Nordisk Investigational Site Katowice
Poland Novo Nordisk Investigational Site Warszawa
Poland Novo Nordisk Investigational Site Wroclaw
Portugal Novo Nordisk Investigational Site Braga
Portugal Novo Nordisk Investigational Site Lisboa
Portugal Novo Nordisk Investigational Site Lisboa
Puerto Rico Novo Nordisk Investigational Site Ponce
Romania Novo Nordisk Investigational Site Bucharest
Romania Novo Nordisk Investigational Site Bucharest
Romania Novo Nordisk Investigational Site Constanta
Romania Novo Nordisk Investigational Site Timisoara Timis
Russian Federation Novo Nordisk Investigational Site Chelyabinsk
Russian Federation Novo Nordisk Investigational Site Izhevsk
Russian Federation Novo Nordisk Investigational Site Krasnoyarsk
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Novosibirsk
Russian Federation Novo Nordisk Investigational Site Saint-Petersburg
Russian Federation Novo Nordisk Investigational Site Saint-Petersburg
Russian Federation Novo Nordisk Investigational Site Saratov
Russian Federation Novo Nordisk Investigational Site Tomsk
Serbia Novo Nordisk Investigational Site Belgrade
Serbia Novo Nordisk Investigational Site Belgrade
Serbia Novo Nordisk Investigational Site Nis
Serbia Novo Nordisk Investigational Site Novi Sad
Spain Novo Nordisk Investigational Site Leganés
Spain Novo Nordisk Investigational Site Madrid
Spain Novo Nordisk Investigational Site Madrid
Spain Novo Nordisk Investigational Site Vigo
Spain Novo Nordisk Investigational Site Vitoria
Sweden Novo Nordisk Investigational Site Göteborg
Sweden Novo Nordisk Investigational Site Huddinge
Sweden Novo Nordisk Investigational Site Uppsala
Taiwan Novo Nordisk Investigational Site Tainan city
Taiwan Novo Nordisk Investigational Site Taoyuan
Thailand Novo Nordisk Investigational Site Bangkok
Thailand Novo Nordisk Investigational Site Chiang Mai
Turkey Novo Nordisk Investigational Site Ankara
Turkey Novo Nordisk Investigational Site Ankara
Turkey Novo Nordisk Investigational Site Istanbul
Turkey Novo Nordisk Investigational Site Kocaeli
United Kingdom Novo Nordisk Investigational Site Birmingham
United Kingdom Novo Nordisk Investigational Site London
United Kingdom Novo Nordisk Investigational Site Manchester
United Kingdom Novo Nordisk Investigational Site Norwich
United Kingdom Novo Nordisk Investigational Site Southampton
United States Novo Nordisk Investigational Site Amarillo Texas
United States Novo Nordisk Investigational Site Atlanta Georgia
United States Novo Nordisk Investigational Site Atlanta Georgia
United States Novo Nordisk Investigational Site Birmingham Alabama
United States Novo Nordisk Investigational Site Bloomington Indiana
United States Novo Nordisk Investigational Site Buffalo New York
United States Novo Nordisk Investigational Site Charleston West Virginia
United States Novo Nordisk Investigational Site Charlottesville Virginia
United States Novo Nordisk Investigational Site Chattanooga Tennessee
United States Novo Nordisk Investigational Site Cincinnati Ohio
United States Novo Nordisk Investigational Site Columbia Missouri
United States Novo Nordisk Investigational Site Columbus Georgia
United States Novo Nordisk Investigational Site Corona California
United States Novo Nordisk Investigational Site Costa Mesa California
United States Novo Nordisk Investigational Site Dallas Texas
United States Novo Nordisk Investigational Site Detroit Michigan
United States Novo Nordisk Investigational Site Edinburg Texas
United States Novo Nordisk Investigational Site Fort Worth Texas
United States Novo Nordisk Investigational Site Grand Rapids Michigan
United States Novo Nordisk Investigational Site Greenville South Carolina
United States Novo Nordisk Investigational Site Hackensack New Jersey
United States Novo Nordisk Investigational Site Hershey Pennsylvania
United States Novo Nordisk Investigational Site Houston Texas
United States Novo Nordisk Investigational Site Houston Texas
United States Novo Nordisk Investigational Site Iowa City Iowa
United States Novo Nordisk Investigational Site Jacksonville Florida
United States Novo Nordisk Investigational Site Kansas City Missouri
United States Novo Nordisk Investigational Site Kerrville Texas
United States Novo Nordisk Investigational Site Las Vegas Nevada
United States Novo Nordisk Investigational Site Lexington Kentucky
United States Novo Nordisk Investigational Site Lexington Kentucky
United States Novo Nordisk Investigational Site Long Beach California
United States Novo Nordisk Investigational Site Los Angeles California
United States Novo Nordisk Investigational Site Los Angeles California
United States Novo Nordisk Investigational Site Melbourne Florida
United States Novo Nordisk Investigational Site Memphis Tennessee
United States Novo Nordisk Investigational Site Memphis Tennessee
United States Novo Nordisk Investigational Site Memphis Tennessee
United States Novo Nordisk Investigational Site Miami Florida
United States Novo Nordisk Investigational Site Miami Florida
United States Novo Nordisk Investigational Site Miami Florida
United States Novo Nordisk Investigational Site Moreno Valley California
United States Novo Nordisk Investigational Site Nashville Tennessee
United States Novo Nordisk Investigational Site New Haven Connecticut
United States Novo Nordisk Investigational Site New York New York
United States Novo Nordisk Investigational Site New York New York
United States Novo Nordisk Investigational Site New York New York
United States Novo Nordisk Investigational Site Norfolk Virginia
United States Novo Nordisk Investigational Site Palo Alto California
United States Novo Nordisk Investigational Site Philadelphia Pennsylvania
United States Novo Nordisk Investigational Site Philadelphia Pennsylvania
United States Novo Nordisk Investigational Site Phoenix Arizona
United States Novo Nordisk Investigational Site Pittsburgh Pennsylvania
United States Novo Nordisk Investigational Site Rapid City South Dakota
United States Novo Nordisk Investigational Site Saint Louis Missouri
United States Novo Nordisk Investigational Site Saint Paul Minnesota
United States Novo Nordisk Investigational Site Saint Petersburg Florida
United States Novo Nordisk Investigational Site San Antonio Texas
United States Novo Nordisk Investigational Site San Diego California
United States Novo Nordisk Investigational Site Silver Spring Maryland
United States Novo Nordisk Investigational Site Sleepy Hollow New York
United States Novo Nordisk Investigational Site Tallahassee Florida
United States Novo Nordisk Investigational Site Tampa Florida
United States Novo Nordisk Investigational Site Toledo Ohio
United States Novo Nordisk Investigational Site Topeka Kansas
United States Novo Nordisk Investigational Site Tucson Arizona
United States Novo Nordisk Investigational Site Ventura California
United States Novo Nordisk Investigational Site Washington District of Columbia
United States Novo Nordisk Investigational Site West Orange New Jersey
United States Novo Nordisk Investigational Site Wilmington Delaware
United States Novo Nordisk Investigational Site Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Croatia,  Denmark,  Egypt,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Lebanon,  Malaysia,  Mexico,  Morocco,  Netherlands,  New Zealand,  North Macedonia,  Norway,  Poland,  Portugal,  Puerto Rico,  Romania,  Russian Federation,  Serbia,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

References & Publications (1)

Tamborlane WV, Barrientos-Pérez M, Fainberg U, Frimer-Larsen H, Hafez M, Hale PM, Jalaludin MY, Kovarenko M, Libman I, Lynch JL, Rao P, Shehadeh N, Turan S, Weghuber D, Barrett T; Ellipse Trial Investigators. Liraglutide in Children and Adolescents with Type 2 Diabetes. N Engl J Med. 2019 Aug 15;381(7):637-646. doi: 10.1056/NEJMoa1903822. Epub 2019 Apr 28. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in HbA1c (Glycosylated Haemoglobin) Change in HbA1c from baseline to week 26. All available data were used for the primary analysis, including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 26
Secondary Change From Baseline in Fasting Plasma Glucose (FPG) Change in FPG from baseline to week 26. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 26
Secondary Number of Subjects Having HbA1c Below 7.0% Percentage of subjects having HbA1c <7.0%. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 26
Secondary Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS) Change in BMI SDS from baseline to week 26. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (WHO) Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 26
Secondary Number of Subjects Having HbA1c Below 7.0% Number of subjects achieving HbA1c <7.0% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 52
Secondary Number of Subjects Having HbA1c Maximum 6.5% Number of subjects achieving HbA1c <=6.5% after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 26
Secondary Number of Subjects Having HbA1c Maximum 6.5% Number of subjects achieving HbA1c <=6.5% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 52
Secondary Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes Number of subjects achieving HbA1c <7.0% without severe or minor hypoglycaemic episodes after 26 weeks.
Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Minor hypoglycaemia was defined as meeting either of the below criteria:
an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself
any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose value <3.1 mmol/L (56 mg/dL) All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Week 26
Secondary Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes Number of subjects achieving HbA1c <7.0% without severe or minor hypoglycaemic episodes after 52 weeks.
Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Minor hypoglycaemia was defined as meeting either of the below criteria:
an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself
any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose value <3.1 mmol/L (56 mg/dL) All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Week 52
Secondary Number of Subjects Having HbA1c Below 7.5% Number of subjects achieving HbA1c <7.5% after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 26
Secondary Number of Subjects Having HbA1c Below 7.5% Number of subjects achieving HbA1c <7.5% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 52
Secondary Change in HbA1c Change in HbA1c from baseline to week 52. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 52
Secondary Change in FPG Change in FPG from baseline to week 52. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 52
Secondary Change in Mean 7-point Self-measured Plasma Glucose Change in mean 7-point self-measured plasma glucose after 26 weeks. Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Mean 7-point SMPG was defined as the area under the profile (calculated using the trapezoidal method) divided by time. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 26
Secondary Change From Baseline in 7-point Self-measured Plasma Glucose Change in mean 7-point self-measured plasma glucose after 52 weeks. Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Mean 7-point SMPG was defined as the area under the profile (calculated using the trapezoidal method) divided by time. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 52
Secondary Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner) Change in post-prandial increments (from before meal to 90 min after breakfast, lunch, and dinner) after 26 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 26
Secondary Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner) Change in post-prandial increments (from before meal to 90 min after breakfast, lunch, and dinner) after 52 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 52
Secondary Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner) Change in mean post-prandial increment across all three meals (breakfast, lunch, and dinner) after 26 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 26
Secondary Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner) Change in mean post-prandial increment across all three meals (breakfast, lunch, and dinner) after 52 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 52
Secondary Change From Baseline in Body Weight Change from baseline in body weight after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 26
Secondary Change From Baseline in Body Weight Change from baseline in body weight after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 52
Secondary Change From Baseline in BMI Standard Deviation Score (SDS) Change in BMI SDS from baseline to week 52. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 52
Secondary Change in Blood Pressure (Systolic and Diastolic Blood Pressure) Change in blood pressure (systolic and diastolic blood pressure) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 26
Secondary Change in Blood Pressure (Systolic and Diastolic Blood Pressure) Change in blood pressure (systolic and diastolic blood pressure) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 52
Secondary Ratio to Baseline: Fasting Insulin Ratio to baseline (fasting insulin) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 26
Secondary Ratio to Baseline: Fasting Insulin Ratio to baseline (fasting insulin) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 52
Secondary Ratio to Baseline: Fasting Pro-insulin Ratio to baseline (fasting pro-insulin) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 26
Secondary Ratio to Baseline: Fasting Pro-insulin Ratio to baseline (fasting pro-insulin) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 52
Secondary Ratio to Baseline: Pro-insulin/Insulin Ratio Ratio to baseline (Pro-insulin/insulin ratio) after week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 26
Secondary Ratio to Baseline: Pro-insulin/Insulin Ratio Ratio to baseline (Pro-insulin/insulin ratio) after week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 52
Secondary Ratio to Baseline: Fasting Glucagon Ratio to baseline (fasting glucagon) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 26
Secondary Ratio to Baseline: Fasting Glucagon Ratio to baseline (fasting glucagon) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 52
Secondary Ratio to Baseline: Fasting C-peptide Ratio to baseline (fasting C-peptide) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 26
Secondary Ratio to Baseline: Fasting C-peptide Ratio to baseline (fasting C-peptide) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 52
Secondary Ratio to Baseline: Homeostasis Model Assessment of Beta-cell Function (HOMA-B) Ratio to baseline (HOMA-B) after 26 weeks. HOMA-B is an index of beta-cell function and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 26
Secondary Ratio to Baseline: HOMA-B Ratio to baseline (HOMA-B) after 52 weeks. HOMA-B is an index of beta-cell function and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 52
Secondary Ratio to Baseline: Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR) Ratio to baseline (HOMA-IR) after 26 weeks. HOMA-IR is an index of insulin resistance and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 26
Secondary Ratio to Baseline: HOMA-IR Ratio to baseline (HOMA-IR) after 52 weeks. HOMA-IR is an index of insulin resistance and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 52
Secondary Ratio to Baseline: Total Cholesterol Ratio to baseline (total cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 26
Secondary Ratio to Baseline: Total Cholesterol Ratio to baseline (total cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 52
Secondary Ratio to Baseline: Low Density Lipoprotein (LDL) Cholesterol Ratio to baseline (LDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 26
Secondary Ratio to Baseline: LDL Cholesterol Ratio to baseline (LDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 52
Secondary Ratio to Baseline: Very Low-density Lipoprotein (VLDL) Cholesterol Ratio to baseline (VLDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 26
Secondary Ratio to Baseline: VLDL Cholesterol Ratio to baseline (VLDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 52
Secondary Ratio to Baseline: High-density Lipoprotein (HDL) Cholesterol Ratio to baseline (HDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 26
Secondary Ratio to Baseline: HDL Cholesterol Ratio to baseline (HDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 52
Secondary Ratio to Baseline: Triglycerides Ratio to baseline (triglycerides) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 26
Secondary Ratio to Baseline: Triglycerides Ratio to baseline (triglycerides) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 52
Secondary Ratio to Baseline: Free Fatty Acids Ratio to baseline (free fatty acids) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 26
Secondary Ratio to Baseline: Free Fatty Acids Ratio to baseline (free fatty acids) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 52
Secondary Change From Baseline in Pulse Change from baseline in pulse 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 26
Secondary Change From Baseline in Pulse Change from baseline in pulse 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 52
Secondary Change From Baseline in Height SDS Change in height SDS from baseline to week 26. Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 26
Secondary Change From Baseline in Height SDS Change in height SDS from baseline to week 52. Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 52
Secondary Change in Bone Age Assessment (X-ray of Left Hand and Wrist) Change in bone age from baseline to week 52. If the baseline (week 0) bone age assessment indicated that all epiphyses were fused, then the assessment was not repeated at week 52. Week 0, week 52
Secondary Pubertal Assessment/Progression (Tanner Staging) Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V. The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of participants at different Tanner stages at week 0, week 26 and week 52. Week 0, week 26, week 52
Secondary Growth (Height Velocity) Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days. Week 0, week 26
Secondary Growth (Height Velocity) Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days. Week 0, week 52
Secondary Height Velocity SDS Height velocity SDS scores at week 26. Height velocity is change in height per year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 26
Secondary Height Velocity SDS Height velocity SDS scores at week 52. Height velocity is change in height per year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. Week 0, week 52
Secondary Number of Hypoglycaemic Episodes Total number of hypoglycaemic episodes according to American Diabetes Association (ADA) classification from baseline (week 0) to week 26. 0-26 weeks
Secondary Number of Hypoglycaemic Episodes Total number of hypoglycaemic episodes according to American Diabetes Association (ADA) classification from baseline (week 0) to week 52. 0-52 weeks
Secondary Number of Adverse Events (Week 0-26) Total number of adverse events during 26 weeks. 0-26 weeks
Secondary Number of Adverse Events (Week 0-52) Total number of adverse events during entire treatment period. 0-52 weeks
Secondary Number of Serious Adverse Events (Week 0-26) Total number of serious adverse events during 26 weeks. 0-26 weeks
Secondary Number of Serious Adverse Events (Week 0-52) Total number of serious adverse events during entire treatment period. 0-52 weeks
Secondary Number of Adverse Events (Week 53-104) This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. Number of adverse events reported during follow-up 1 (week 53 to 104). Week 53-104
Secondary Number of Serious Adverse Events (Week 53-104) This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. Number of serious adverse events reported during follow up 1 (week 53 to 104). Weeks 53-104
Secondary Growth (Height Velocity)- Week 104 Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. Week 0, week 104
Secondary Height Velocity SDS- Week 104 The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. Week 0, week 104
Secondary Change From Week 52 in Height SDS- Week 104 Change in height SDS from week 52 to week 104. Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. Week 52, week 104
Secondary Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V, where stage I represents "pre-adoloscent development" and stage V represents "pubertal development equivalent to that of an adult". The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of subjects at different Tanner stages at week 52 and week 104. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. Week 52, week 104
Secondary Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 104 Change in bone age from week 52 to week 104. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. Week 52, week 104
Secondary Number of Adverse Events (Week 53-156) This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. Number of adverse events reported during the follow-up period (weeks 53 to 156). Week 53-156
Secondary Number of Serious Adverse Events (Week 53-156) This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. Number of serious adverse events reported during the follow up period (week 53 to 156). Weeks 53-156
Secondary Growth (Height Velocity)- Week 156 Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. Week 0, week 156
Secondary Height Velocity SDS- Week 156 The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. Week 0, week 156
Secondary Change From Week 52 in Height SDS- Week 156 Change in height SDS from week 52 to week 156. Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. Week 52, week 156
Secondary Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V, where stage I represents "pre-adoloscent development" and stage V represents "pubertal development equivalent to that of an adult". The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of subjects at different Tanner stages at week 52 and week 156. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. Week 52, week 156
Secondary Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 156 Change in bone age from week 52 to week 156. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. Week 52, week 156
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