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. |
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Condition | Diabetes Diabetes Mellitus, Type 2 |
Intervention | Drug: liraglutide Drug: placebo Drug: metformin |
Phase | Phase 3 |
Sponsor | Novo Nordisk A/S |
Responsible Party | Novo Nordisk A/S |
ClinicalTrials.gov Identifier | NCT01541215 |
First Received | February 23, 2012 |
Last Updated | December 19, 2013 |
Last verified | December 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | February 23, 2012 |
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Last Updated Date | December 19, 2013 |
Start Date | November 2012 |
Estimated Primary Completion Date | November 2017 |
Current Primary Outcome Measures | Change in HbA1c (glycosylated haemoglobin) [Time Frame: Week 0, week 26] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes |
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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 |
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 Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition |
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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. 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) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 172 |
Estimated Completion Date | November 2017 |
Estimated Primary Completion Date | December 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 |
Gender | Both |
Ages | 10 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Novo Nordisk clinicaltrials@novonordisk.com |
Location Countries | United 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 |
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Other Study ID Numbers | NN2211-3659 |
Has Data Monitoring Committee | No |
Information Provided By | Novo Nordisk A/S |
Study Sponsor | Novo Nordisk A/S |
Collaborators | Not Provided |
Investigators | Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S |
Verification Date | December 2013 |
Locations[ + expand ][ + ]
Novo Nordisk Clinical Trial Call Center | Birmingham, Alabama, United States, 35233 Recruiting |
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Novo Nordisk Clinical Trial Call Center | Phoenix, Arizona, United States, 85053 Recruiting |
Novo Nordisk Clinical Trial Call Center | Costa Mesa, California, United States, 92626 Recruiting |
Novo Nordisk Clinical Trial Call Center | Long Beach, California, United States, 90806 Recruiting |
Novo Nordisk Clinical Trial Call Center | Los Angeles, California, United States, 90027 Recruiting |
Novo Nordisk Clinical Trial Call Center | Palo Alto, California, United States, 94305-5208 Recruiting |
Novo Nordisk Clinical Trial Call Center | New Haven, Connecticut, United States, 06520 Recruiting |
Novo Nordisk Clinical Trial Call Center | Wilmington, Delaware, United States, 19803 Recruiting |
Novo Nordisk Clinical Trial Call Center | Melbourne, Florida, United States, 32901 Recruiting |
Novo Nordisk Clinical Trial Call Center | Miami, Florida, United States, 33155 Recruiting |
Novo Nordisk Clinical Trial Call Center | Miami, Florida, United States, 33144 Recruiting |
Novo Nordisk Clinical Trial Call Center | Tampa, Florida, United States, 33612 Recruiting |
Novo Nordisk Clinical Trial Call Center | Atlanta, Georgia, United States, 30318 Recruiting |
Novo Nordisk Clinical Trial Call Center | Atlanta, Georgia, United States, 30322 Recruiting |
Novo Nordisk Clinical Trial Call Center | Columbus, Georgia, United States, 31904 Recruiting |
Novo Nordisk Clinical Trial Call Center | Iowa City, Iowa, United States, 52242 Recruiting |
Novo Nordisk Clinical Trial Call Center | Topeka, Kansas, United States, 66606 Recruiting |
Novo Nordisk Clinical Trial Call Center | Baltimore, Maryland, United States, 21201 Recruiting |
Novo Nordisk Clinical Trial Call Center | Silver Spring, Maryland, United States, 20910 Recruiting |
Novo Nordisk Clinical Trial Call Center | Worcester, Massachusetts, United States, 01655 Recruiting |
Novo Nordisk Clinical Trial Call Center | Detroit, Michigan, United States, 48201 Recruiting |
Novo Nordisk Clinical Trial Call Center | Columbia, Missouri, United States, 65201 Recruiting |
Novo Nordisk Clinical Trial Call Center | Las Vegas, Nevada, United States, 89148 Recruiting |
Novo Nordisk Clinical Trial Call Center | Hackensack, New Jersey, United States, 07601 Recruiting |
Novo Nordisk Clinical Trial Call Center | Livingston, New Jersey, United States, 07039 Recruiting |
Novo Nordisk Clinical Trial Call Center | Mineola, New York, United States, 11501 Recruiting |
Novo Nordisk Clinical Trial Call Center | New York, New York, United States, 10029 Recruiting |
Novo Nordisk Clinical Trial Call Center | New York, New York, United States, 10016 Recruiting |
Novo Nordisk Clinical Trial Call Center | Sleepy Hollow, New York, United States, 10591 Recruiting |
Novo Nordisk Clinical Trial Call Center | Cincinnati, Ohio, United States, 45229 Recruiting |
Novo Nordisk Clinical Trial Call Center | Toledo, Ohio, United States, 43606 Recruiting |
Novo Nordisk Clinical Trial Call Center | Hershey, Pennsylvania, United States, 17033 Recruiting |
Novo Nordisk Clinical Trial Call Center | Pittsburgh, Pennsylvania, United States, 15224 Recruiting |
Novo Nordisk Clinical Trial Call Center | Columbia, South Carolina, United States, 29203 Recruiting |
Novo Nordisk Clinical Trial Call Center | Rapid City, South Dakota, United States, 57701 Recruiting |
Novo Nordisk Clinical Trial Call Center | Memphis, Tennessee, United States, 38119 Recruiting |
Novo Nordisk Clinical Trial Call Center | Memphis, Tennessee, United States, 38119-3821 Recruiting |
Novo Nordisk Clinical Trial Call Center | Memphis, Tennessee, United States, 38103-2800 Recruiting |
Novo Nordisk Clinical Trial Call Center | Dallas, Texas, United States, 75235 Recruiting |
Novo Nordisk Clinical Trial Call Center | Fort Worth, Texas, United States, 76104 Recruiting |
Novo Nordisk Clinical Trial Call Center | Houston, Texas, United States, 77025 Recruiting |
Novo Nordisk Clinical Trial Call Center | Schertz, Texas, United States, 78154 Recruiting |
Novo Nordisk Clinical Trial Call Center | Sugar Land, Texas, United States, 77478 Recruiting |
Novo Nordisk Clinical Trial Call Center | Norfolk, Virginia, United States, 23507 Recruiting |
Novo Nordisk Clinical Trial Call Center | Charleston, West Virginia, United States, 25302 Recruiting |
Belgium | Brussels, Belgium, 1090 Recruiting |
Brazil | Porto Alegre, Brazil, 91350-250 Recruiting |
Canada, Manitoba | Winnipeg, Manitoba, Canada, R3E 3P4 Recruiting |
Croatia | Zagreb, Croatia, 10 000 Recruiting |
Denmark | Herlev, Denmark, 2730 Recruiting |
Germany | Ludwigshafen, Germany, 67059 Recruiting |
Greece | Athens, Greece, 151 23 Recruiting |
Hungary | Budapest, Hungary, 1023 Recruiting |
India, Karnataka | Bangalore, Karnataka, India, 560052 Recruiting |
Israel | Jerusalem, Israel, 91240 Recruiting |
Macedonia, The Former Yugoslav Republic of | Skopje, Macedonia, The Former Yugoslav Republic of, 1000 Recruiting |
Mexico | Puebla, Mexico, 72190 Recruiting |
Norway | Bergen, Norway, 5021 Recruiting |
Russian Federation | Moscow, Russian Federation, 117036 Recruiting |
Serbia | Belgrade, Serbia, 11070 Recruiting |
Spain | Madrid, Spain, 28046 Recruiting |
Sweden | Stockholm, Sweden, 141 86 Recruiting |
Turkey | Istanbul, Turkey, 34355 Recruiting |
United Kingdom | Birmingham, United Kingdom, B4 6NH Recruiting |