Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes

Overview[ - collapse ][ - ]

Purpose 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.
ConditionDiabetes
Diabetes Mellitus, Type 2
InterventionDrug: liraglutide
Drug: placebo
Drug: metformin
PhasePhase 3
SponsorNovo Nordisk A/S
Responsible PartyNovo Nordisk A/S
ClinicalTrials.gov IdentifierNCT01541215
First ReceivedFebruary 23, 2012
Last UpdatedDecember 19, 2013
Last verifiedDecember 2013

Tracking Information[ + expand ][ + ]

First Received DateFebruary 23, 2012
Last Updated DateDecember 19, 2013
Start DateNovember 2012
Estimated Primary Completion DateNovember 2017
Current Primary Outcome MeasuresChange in HbA1c (glycosylated haemoglobin) [Time Frame: Week 0, week 26] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Number of subjects having HbA1c below 7.0% [Time Frame: Week 26] [Designated as safety issue: No]
  • Number of subjects having HbA1c below 7.0% [Time Frame: Week 52] [Designated as safety issue: No]
  • Number of subjects having HbA1c maximum 6.5% [Time Frame: Week 26] [Designated as safety issue: No]
  • Number of subjects having HbA1c maximum 6.5% [Time Frame: Week 52] [Designated as safety issue: No]
  • Number of subjects having HbA1c below 7.0% without severe or minor hypoglycaemic episodes [Time Frame: Week 26] [Designated as safety issue: No]
  • Number of subjects having HbA1c below 7.0% without severe or minor hypoglycaemic episodes [Time Frame: Week 52] [Designated as safety issue: No]
  • Change from baseline in fasting plasma glucose (FPG) [Time Frame: Week 0, week 26] [Designated as safety issue: No]
  • Change from baseline in fasting plasma glucose (FPG) [Time Frame: Week 0, week 52] [Designated as safety issue: No]
  • Change from baseline in 7-point self-measured plasma glucose [Time Frame: Week 0, week 26] [Designated as safety issue: No]
  • Change from baseline in 7-point self-measured plasma glucose [Time Frame: Week 0, week 52] [Designated as safety issue: No]
  • Change from baseline in body weight [Time Frame: Week 0, week 26] [Designated as safety issue: No]
  • Change from baseline in body weight [Time Frame: Week 0, week 52] [Designated as safety issue: No]
  • Change from baseline in BMI standard deviation score (SDS) [Time Frame: Week 0, week 26] [Designated as safety issue: No]
  • Change from baseline in BMI standard deviation score (SDS) [Time Frame: Week 0, week 52] [Designated as safety issue: No]
  • Number of adverse events (AEs) [Time Frame: Week 26] [Designated as safety issue: No]
  • Number of adverse events (AEs) [Time Frame: Week 52] [Designated as safety issue: No]
  • Number of adverse events (AEs) [Time Frame: week 104 (1 year follow-up)] [Designated as safety issue: No]
  • Number of adverse events (AEs) [Time Frame: Week 156 (2 year follow-up)] [Designated as safety issue: No]
  • Number of serious adverse events (SAEs) [Time Frame: Week 26] [Designated as safety issue: No]
  • Number of serious adverse events (SAEs) [Time Frame: Week 52] [Designated as safety issue: No]
  • Number of serious adverse events (SAEs) [Time Frame: Week 104 (1 year follow-up)] [Designated as safety issue: No]
  • Number of serious adverse events (SAEs) [Time Frame: Week 156 (2 year follow-up )] [Designated as safety issue: No]
  • Growth velocity [Time Frame: Week 104 (1 year follow-up)] [Designated as safety issue: No]
  • Growth velocity [Time Frame: Week 156 (2 year follow-up)] [Designated as safety issue: No]
  • Pubertal progression [Time Frame: Week 104 (1 year follow-up)] [Designated as safety issue: No]
  • Pubertal progression [Time Frame: Week 156 (2 year follow-up)] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleEfficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes
Official TitleEfficacy and Safety of Liraglutide in Combination With Metformin Versus Metformin Monotherapy on Glycaemic Control in Children and Adolescents With Type 2 Diabetes
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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Condition
  • Diabetes
  • Diabetes Mellitus, Type 2
InterventionDrug: 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.
Drug: 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.
Drug: 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.
Study Arm (s)
  • Experimental: Lira + Met
  • Placebo Comparator: Placebo + Met

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment172
Estimated Completion DateNovember 2017
Estimated Primary Completion DateDecember 2015
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 90 days with diet and
exercise alone, or diet and exercise in combination with metformin monotherapy.

- HbA1c: 7.0-11% (inclusive) if diet and exercise treated or 6.5-11% (inclusive) if
treated with metformin

- 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 within 90 days prior to screening.
Short term treatment with insulin is allowed

- 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
GenderBoth
Ages10 Years
Accepts Healthy VolunteersNo
ContactsContact: Novo Nordisk
clinicaltrials@novonordisk.com
Location CountriesUnited States, Belgium, Brazil, Canada, Croatia, Denmark, Germany, Greece, Hungary, India, Israel, Macedonia, The Former Yugoslav Republic of, Mexico, Norway, Russian Federation, Serbia, Spain, Sweden, Turkey, United Kingdom

Administrative Information[ + expand ][ + ]

NCT Number NCT01541215
Other Study ID NumbersNN2211-3659
Has Data Monitoring CommitteeNo
Information Provided ByNovo Nordisk A/S
Study SponsorNovo Nordisk A/S
CollaboratorsNot Provided
Investigators Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Verification DateDecember 2013

Locations[ + expand ][ + ]

Novo Nordisk Clinical Trial Call Center
Birmingham, Alabama, United States, 35233
Recruiting
Novo Nordisk Clinical Trial Call Center
Phoenix, Arizona, United States, 85053
Recruiting
Novo Nordisk Clinical Trial Call Center
Costa Mesa, California, United States, 92626
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Novo Nordisk Clinical Trial Call Center
Long Beach, California, United States, 90806
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Novo Nordisk Clinical Trial Call Center
Los Angeles, California, United States, 90027
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Novo Nordisk Clinical Trial Call Center
Palo Alto, California, United States, 94305-5208
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Novo Nordisk Clinical Trial Call Center
New Haven, Connecticut, United States, 06520
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Novo Nordisk Clinical Trial Call Center
Wilmington, Delaware, United States, 19803
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Novo Nordisk Clinical Trial Call Center
Melbourne, Florida, United States, 32901
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Novo Nordisk Clinical Trial Call Center
Miami, Florida, United States, 33155
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Novo Nordisk Clinical Trial Call Center
Miami, Florida, United States, 33144
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Novo Nordisk Clinical Trial Call Center
Tampa, Florida, United States, 33612
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Novo Nordisk Clinical Trial Call Center
Atlanta, Georgia, United States, 30318
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Novo Nordisk Clinical Trial Call Center
Atlanta, Georgia, United States, 30322
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Novo Nordisk Clinical Trial Call Center
Columbus, Georgia, United States, 31904
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Novo Nordisk Clinical Trial Call Center
Iowa City, Iowa, United States, 52242
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Novo Nordisk Clinical Trial Call Center
Topeka, Kansas, United States, 66606
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Novo Nordisk Clinical Trial Call Center
Baltimore, Maryland, United States, 21201
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Novo Nordisk Clinical Trial Call Center
Silver Spring, Maryland, United States, 20910
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Novo Nordisk Clinical Trial Call Center
Worcester, Massachusetts, United States, 01655
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Novo Nordisk Clinical Trial Call Center
Detroit, Michigan, United States, 48201
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Novo Nordisk Clinical Trial Call Center
Columbia, Missouri, United States, 65201
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Novo Nordisk Clinical Trial Call Center
Las Vegas, Nevada, United States, 89148
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Novo Nordisk Clinical Trial Call Center
Hackensack, New Jersey, United States, 07601
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Novo Nordisk Clinical Trial Call Center
Livingston, New Jersey, United States, 07039
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Novo Nordisk Clinical Trial Call Center
Mineola, New York, United States, 11501
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Novo Nordisk Clinical Trial Call Center
New York, New York, United States, 10029
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Novo Nordisk Clinical Trial Call Center
New York, New York, United States, 10016
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Novo Nordisk Clinical Trial Call Center
Sleepy Hollow, New York, United States, 10591
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Novo Nordisk Clinical Trial Call Center
Cincinnati, Ohio, United States, 45229
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Novo Nordisk Clinical Trial Call Center
Toledo, Ohio, United States, 43606
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Novo Nordisk Clinical Trial Call Center
Hershey, Pennsylvania, United States, 17033
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Novo Nordisk Clinical Trial Call Center
Pittsburgh, Pennsylvania, United States, 15224
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Novo Nordisk Clinical Trial Call Center
Columbia, South Carolina, United States, 29203
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Novo Nordisk Clinical Trial Call Center
Rapid City, South Dakota, United States, 57701
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Novo Nordisk Clinical Trial Call Center
Memphis, Tennessee, United States, 38119
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Novo Nordisk Clinical Trial Call Center
Memphis, Tennessee, United States, 38119-3821
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Novo Nordisk Clinical Trial Call Center
Memphis, Tennessee, United States, 38103-2800
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Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75235
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Novo Nordisk Clinical Trial Call Center
Fort Worth, Texas, United States, 76104
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Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77025
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Novo Nordisk Clinical Trial Call Center
Schertz, Texas, United States, 78154
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Novo Nordisk Clinical Trial Call Center
Sugar Land, Texas, United States, 77478
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Novo Nordisk Clinical Trial Call Center
Norfolk, Virginia, United States, 23507
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Novo Nordisk Clinical Trial Call Center
Charleston, West Virginia, United States, 25302
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Belgium
Brussels, Belgium, 1090
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Brazil
Porto Alegre, Brazil, 91350-250
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Canada, Manitoba
Winnipeg, Manitoba, Canada, R3E 3P4
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Croatia
Zagreb, Croatia, 10 000
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Denmark
Herlev, Denmark, 2730
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Germany
Ludwigshafen, Germany, 67059
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Greece
Athens, Greece, 151 23
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Hungary
Budapest, Hungary, 1023
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India, Karnataka
Bangalore, Karnataka, India, 560052
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Israel
Jerusalem, Israel, 91240
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Macedonia, The Former Yugoslav Republic of
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
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Mexico
Puebla, Mexico, 72190
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Norway
Bergen, Norway, 5021
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Russian Federation
Moscow, Russian Federation, 117036
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Serbia
Belgrade, Serbia, 11070
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Spain
Madrid, Spain, 28046
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Sweden
Stockholm, Sweden, 141 86
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Turkey
Istanbul, Turkey, 34355
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United Kingdom
Birmingham, United Kingdom, B4 6NH
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