Clinical trial NCT01541215: Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes
Official title: Efficacy and Safety of Liraglutide in Combination With Metformin Versus Metformin Monotherapy on Glycaemic Control in Children and Adolescents With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-02-29
Enrollment: 135
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in HbA1c (Glycosylated Haemoglobin)
timeFrame: Week 0, week 26
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose (FPG)
timeFrame: Week 0, week 26
measure: Number of Subjects Having HbA1c Below 7.0%
timeFrame: Week 26
measure: Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS)
timeFrame: Week 0, week 26
measure: Number of Subjects Having HbA1c Below 7.0%
timeFrame: Week 52
measure: Number of Subjects Having HbA1c Maximum 6.5%
timeFrame: Week 26
measure: Number of Subjects Having HbA1c Maximum 6.5%
timeFrame: Week 52
measure: Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes
timeFrame: Week 26
measure: Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes
timeFrame: Week 52
measure: Number of Subjects Having HbA1c Below 7.5%
timeFrame: Week 26
measure: Number of Subjects Having HbA1c Below 7.5%
timeFrame: Week 52
measure: Change in HbA1c
timeFrame: Week 0, week 52
measure: Change in FPG
timeFrame: Week 0, week 52
measure: Change in Mean 7-point Self-measured Plasma Glucose
timeFrame: Week 0, week 26
measure: Change From Baseline in 7-point Self-measured Plasma Glucose
timeFrame: Week 0, week 52
measure: Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)
timeFrame: Week 0, week 26
measure: Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)
timeFrame: Week 0, week 52
measure: Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)
timeFrame: Week 0, week 26
measure: Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)
timeFrame: Week 0, week 52
measure: Change From Baseline in Body Weight
timeFrame: Week 0, week 26
measure: Change From Baseline in Body Weight
timeFrame: Week 0, week 52
measure: Change From Baseline in BMI Standard Deviation Score (SDS)
timeFrame: Week 0, week 52
measure: Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
timeFrame: Week 0, week 26
measure: Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
timeFrame: Week 0, week 52
measure: Ratio to Baseline: Fasting Insulin
timeFrame: Week 0, week 26
measure: Ratio to Baseline: Fasting Insulin
timeFrame: Week 0, week 52
measure: Ratio to Baseline: Fasting Pro-insulin
timeFrame: Week 0, week 26
measure: Ratio to Baseline: Fasting Pro-insulin
timeFrame: Week 0, week 52
measure: Ratio to Baseline: Pro-insulin/Insulin Ratio
timeFrame: Week 0, week 26
measure: Ratio to Baseline: Pro-insulin/Insulin Ratio
timeFrame: Week 0, week 52
measure: Ratio to Baseline: Fasting Glucagon
timeFrame: Week 0, week 26
measure: Ratio to Baseline: Fasting Glucagon
timeFrame: Week 0, week 52
measure: Ratio to Baseline: Fasting C-peptide
timeFrame: Week 0, week 26
measure: Ratio to Baseline: Fasting C-peptide
timeFrame: Week 0, week 52
measure: Ratio to Baseline: Homeostasis Model Assessment of Beta-cell Function (HOMA-B)
timeFrame: Week 0, week 26
measure: Ratio to Baseline: HOMA-B
timeFrame: Week 0, week 52
measure: Ratio to Baseline: Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)
timeFrame: Week 0, week 26
measure: Ratio to Baseline: HOMA-IR
timeFrame: Week 0, week 52
measure: Ratio to Baseline: Total Cholesterol
timeFrame: Week 0, week 26
measure: Ratio to Baseline: Total Cholesterol
timeFrame: Week 0, week 52
measure: Ratio to Baseline: Low Density Lipoprotein (LDL) Cholesterol
timeFrame: Week 0, week 26
measure: Ratio to Baseline: LDL Cholesterol
timeFrame: Week 0, week 52
measure: Ratio to Baseline: Very Low-density Lipoprotein (VLDL) Cholesterol
timeFrame: Week 0, week 26
measure: Ratio to Baseline: VLDL Cholesterol
timeFrame: Week 0, week 52
measure: Ratio to Baseline: High-density Lipoprotein (HDL) Cholesterol
timeFrame: Week 0, week 26
measure: Ratio to Baseline: HDL Cholesterol
timeFrame: Week 0, week 52
measure: Ratio to Baseline: Triglycerides
timeFrame: Week 0, week 26
measure: Ratio to Baseline: Triglycerides
timeFrame: Week 0, week 52
measure: Ratio to Baseline: Free Fatty Acids
timeFrame: Week 0, week 26
measure: Ratio to Baseline: Free Fatty Acids
timeFrame: Week 0, week 52
measure: Change From Baseline in Pulse
timeFrame: Week 0, week 26
measure: Change From Baseline in Pulse
timeFrame: Week 0, week 52
measure: Change From Baseline in Height SDS
timeFrame: Week 0, week 26
measure: Change From Baseline in Height SDS
timeFrame: Week 0, week 52
measure: Change in Bone Age Assessment (X-ray of Left Hand and Wrist)
timeFrame: Week 0, week 52
measure: Pubertal Assessment/Progression (Tanner Staging)
timeFrame: Week 0, week 26, week 52
measure: Growth (Height Velocity)
timeFrame: Week 0, week 26
measure: Growth (Height Velocity)
timeFrame: Week 0, week 52
measure: Height Velocity SDS
timeFrame: Week 0, week 26
measure: Height Velocity SDS
timeFrame: Week 0, week 52
measure: Number of Hypoglycaemic Episodes
timeFrame: 0-26 weeks
measure: Number of Hypoglycaemic Episodes
timeFrame: 0-52 weeks
measure: Number of Adverse Events (Week 0-26)
timeFrame: 0-26 weeks
measure: Number of Adverse Events (Week 0-52)
timeFrame: 0-52 weeks
measure: Number of Serious Adverse Events (Week 0-26)
timeFrame: 0-26 weeks
measure: Number of Serious Adverse Events (Week 0-52)
timeFrame: 0-52 weeks
measure: Number of Adverse Events (Week 53-104)
timeFrame: Week 53-104
measure: Number of Serious Adverse Events (Week 53-104)
timeFrame: Weeks 53-104
measure: Growth (Height Velocity)- Week 104
timeFrame: Week 0, week 104
measure: Height Velocity SDS- Week 104
timeFrame: Week 0, week 104
measure: Change From Week 52 in Height SDS- Week 104
timeFrame: Week 52, week 104
measure: Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104
timeFrame: Week 52, week 104
measure: Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 104
timeFrame: Week 52, week 104
measure: Number of Adverse Events (Week 53-156)
timeFrame: Week 53-156
measure: Number of Serious Adverse Events (Week 53-156)
timeFrame: Weeks 53-156
measure: Growth (Height Velocity)- Week 156
timeFrame: Week 0, week 156
measure: Height Velocity SDS- Week 156
timeFrame: Week 0, week 156
measure: Change From Week 52 in Height SDS- Week 156
timeFrame: Week 52, week 156
measure: Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156
timeFrame: Week 52, week 156
measure: Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 156
timeFrame: Week 52, week 156
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Corona
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Costa Mesa
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Long Beach
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Los Angeles
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Los Angeles
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Moreno Valley
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Palo Alto
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: San Diego
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Ventura
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: New Haven
country: United States
facility: Novo Nordisk Investigational Site
state: Connecticut
city: Wilmington
country: United States
facility: Novo Nordisk Investigational Site
state: Delaware
city: Washington
country: United States
facility: Novo Nordisk Investigational Site
state: District of Columbia
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Melbourne
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Tallahassee
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Tampa
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Columbus
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Bloomington
country: United States
facility: Novo Nordisk Investigational Site
state: Indiana
city: Iowa City
country: United States
facility: Novo Nordisk Investigational Site
state: Iowa
city: Topeka
country: United States
facility: Novo Nordisk Investigational Site
state: Kansas
city: Lexington
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Lexington
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Silver Spring
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Worcester
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Detroit
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: Grand Rapids
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: Saint Paul
country: United States
facility: Novo Nordisk Investigational Site
state: Minnesota
city: Columbia
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Kansas City
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Novo Nordisk Investigational Site
state: Nevada
city: Hackensack
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: West Orange
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Buffalo
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: New York
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: New York
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: New York
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Sleepy Hollow
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Cincinnati
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Toledo
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Hershey
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Greenville
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Rapid City
country: United States
facility: Novo Nordisk Investigational Site
state: South Dakota
city: Chattanooga
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Amarillo
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Edinburg
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Kerrville
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Charlottesville
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Charleston
country: United States
facility: Novo Nordisk Investigational Site
state: West Virginia
city: Ipswich
country: Australia
facility: Novo Nordisk Investigational Site
state: Queensland
city: Graz
country: Austria
facility: Novo Nordisk Investigational Site
city: Innsbruck
country: Austria
facility: Novo Nordisk Investigational Site
city: Salzburg
country: Austria
facility: Novo Nordisk Investigational Site
city: Wels
country: Austria
facility: Novo Nordisk Investigational Site
city: Brussel
country: Belgium
facility: Novo Nordisk Investigational Site
city: Bruxelles
country: Belgium
facility: Novo Nordisk Investigational Site
city: Leuven
country: Belgium
facility: Novo Nordisk Investigational Site
city: Porto Alegre
country: Brazil
facility: Novo Nordisk Investigational Site
state: Rio Grande Do Sul
city: Edmonton
country: Canada
facility: Novo Nordisk Investigational Site
state: Alberta
city: Winnipeg
country: Canada
facility: Novo Nordisk Investigational Site
state: Manitoba
city: Brampton
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Westmount
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Rijeka
country: Croatia
facility: Novo Nordisk Investigational Site
city: Zagreb
country: Croatia
facility: Novo Nordisk Investigational Site
city: Herlev
country: Denmark
facility: Novo Nordisk Investigational Site
city: Næstved
country: Denmark
facility: Novo Nordisk Investigational Site
city: Alexandria
country: Egypt
facility: Novo Nordisk Investigational Site
city: Cairo
country: Egypt
facility: Novo Nordisk Investigational Site
city: Cairo
country: Egypt
facility: Novo Nordisk Investigational Site
city: Mansoura
country: Egypt
facility: Novo Nordisk Investigational Site
city: Marseille
country: France
facility: Novo Nordisk Investigational Site
city: MONTPELLIER cedex 05
country: France
facility: Novo Nordisk Investigational Site
city: Ludwigshafen
country: Germany
facility: Novo Nordisk Investigational Site
city: Mayen
country: Germany
facility: Novo Nordisk Investigational Site
city: Athens
country: Greece
facility: Novo Nordisk Investigational Site
city: Athens
country: Greece
facility: Novo Nordisk Investigational Site
city: Goudi/ Athens
country: Greece
facility: Novo Nordisk Investigational Site
city: Thessaloniki
country: Greece
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Miskolc
country: Hungary
facility: Novo Nordisk Investigational Site
city: Szombathely
country: Hungary
facility: Novo Nordisk Investigational Site
city: Guntur
country: India
facility: Novo Nordisk Investigational Site
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Novo Nordisk Investigational Site
state: Andhra Pradesh
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Mumbai
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Mumbai
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Pune
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: New Dehli
country: India
facility: Novo Nordisk Investigational Site
state: New Delhi
city: Chandigarh
country: India
facility: Novo Nordisk Investigational Site
state: Punjab
city: Ludhiana
country: India
facility: Novo Nordisk Investigational Site
state: Punjab
city: Jaipur
country: India
facility: Novo Nordisk Investigational Site
state: Rajasthan
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Hyderbad
country: India
facility: Novo Nordisk Investigational Site
state: Telengana
city: Kolkata
country: India
facility: Novo Nordisk Investigational Site
state: West Bengal
city: Kolkata
country: India
facility: Novo Nordisk Investigational Site
city: Beer Sheva
country: Israel
facility: Novo Nordisk Investigational Site
city: Haifa
country: Israel
facility: Novo Nordisk Investigational Site
city: Jerusalem
country: Israel
facility: Novo Nordisk Investigational Site
city: Petah Tikva
country: Israel
facility: Novo Nordisk Investigational Site
city: Tel Hashomer
country: Israel
facility: Novo Nordisk Investigational Site
city: Roma
country: Italy
facility: Novo Nordisk Investigational Site
city: Hazmieh
country: Lebanon
facility: Novo Nordisk Investigational Site
city: Lebanon - Beirut
country: Lebanon
facility: Novo Nordisk Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Tampico
country: Mexico
facility: Novo Nordisk Investigational Site
state: Tamaulipas
city: Puebla
country: Mexico
facility: Novo Nordisk Investigational Site
city: Fès
country: Morocco
facility: Novo Nordisk Investigational Site
city: Rabat
country: Morocco
facility: Novo Nordisk Investigational Site
city: Den Bosch
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Grafton
country: New Zealand
facility: Novo Nordisk Investigational Site
city: Skopje
country: North Macedonia
facility: Novo Nordisk Investigational Site
city: Bergen
country: Norway
facility: Novo Nordisk Investigational Site
city: Katowice
country: Poland
facility: Novo Nordisk Investigational Site
city: Warszawa
country: Poland
facility: Novo Nordisk Investigational Site
city: Wroclaw
country: Poland
facility: Novo Nordisk Investigational Site
city: Braga
country: Portugal
facility: Novo Nordisk Investigational Site
city: Lisboa
country: Portugal
facility: Novo Nordisk Investigational Site
city: Lisboa
country: Portugal
facility: Novo Nordisk Investigational Site
city: Ponce
country: Puerto Rico
facility: Novo Nordisk Investigational Site
city: Timisoara
country: Romania
facility: Novo Nordisk Investigational Site
state: Timis
city: Bucharest
country: Romania
facility: Novo Nordisk Investigational Site
city: Bucharest
country: Romania
facility: Novo Nordisk Investigational Site
city: Constanta
country: Romania
facility: Novo Nordisk Investigational Site
city: Chelyabinsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Izhevsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Krasnoyarsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Novosibirsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saratov
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Tomsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Belgrade
country: Serbia
facility: Novo Nordisk Investigational Site
city: Belgrade
country: Serbia
facility: Novo Nordisk Investigational Site
city: Nis
country: Serbia
facility: Novo Nordisk Investigational Site
city: Novi Sad
country: Serbia
facility: Novo Nordisk Investigational Site
city: Leganés
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Vigo
country: Spain
facility: Novo Nordisk Investigational Site
city: Vitoria
country: Spain
facility: Novo Nordisk Investigational Site
city: Göteborg
country: Sweden
facility: Novo Nordisk Investigational Site
city: Huddinge
country: Sweden
facility: Novo Nordisk Investigational Site
city: Uppsala
country: Sweden
facility: Novo Nordisk Investigational Site
city: Tainan city
country: Taiwan
facility: Novo Nordisk Investigational Site
city: Taoyuan
country: Taiwan
facility: Novo Nordisk Investigational Site
city: Bangkok
country: Thailand
facility: Novo Nordisk Investigational Site
city: Chiang Mai
country: Thailand
facility: Novo Nordisk Investigational Site
city: Ankara
country: Turkey
facility: Novo Nordisk Investigational Site
city: Ankara
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Kocaeli
country: Turkey
facility: Novo Nordisk Investigational Site
city: Birmingham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Manchester
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Norwich
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Southampton
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
References:
citation: Tamborlane WV, Barrientos-Perez 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.
citation: Bensignor MO, Bomberg EM, Bramante CT, Divyalasya TVS, Hale PM, Ramesh CK, Rudser KD, Kelly AS. Effect of liraglutide treatment on body mass index and weight parameters in children and adolescents with type 2 diabetes: Post hoc analysis of the ellipse trial. Pediatr Obes. 2021 Aug;16(8):e12778. doi: 10.1111/ijpo.12778. Epub 2021 Feb 25.