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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Novo Nordisk A/S
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01541215
First received: February 23, 2012
Last updated: June 25, 2015
Last verified: June 2015
  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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: liraglutide
Drug: placebo
Drug: metformin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in HbA1c (glycosylated haemoglobin) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]

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 ]

Estimated Enrollment: 150
Study Start Date: November 2012
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lira + Met 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: 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.
Placebo Comparator: Placebo + 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.

  Eligibility

Ages Eligible for Study:   10 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01541215

Contacts
Contact: Novo Nordisk clinicaltrials@novonordisk.com

  Hide Study Locations
Locations
United States, Alabama
Novo Nordisk Clinical Trial Call Center Recruiting
Birmingham, Alabama, United States, 35233
United States, Arizona
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Phoenix, Arizona, United States, 85053
United States, California
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Corona, California, United States, 92880
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Costa Mesa, California, United States, 92626
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Long Beach, California, United States, 90806-1600
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Los Angeles, California, United States, 90048-1869
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Los Angeles, California, United States, 90027
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Moreno Valley, California, United States, 92555
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Palo Alto, California, United States, 94305-5208
United States, Connecticut
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New Haven, Connecticut, United States, 06520
United States, Delaware
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Wilmington, Delaware, United States, 19803
United States, Florida
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Melbourne, Florida, United States, 32901
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Miami, Florida, United States, 33155
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Miami, Florida, United States, 33144
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Miami, Florida, United States, 33126
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St. Petersburg, Florida, United States, 33701
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Tallahassee, Florida, United States, 32308
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Tampa, Florida, United States, 33612
United States, Georgia
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Atlanta, Georgia, United States, 30318
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Atlanta, Georgia, United States, 30322
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Columbus, Georgia, United States, 31904
United States, Indiana
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Bloomington, Indiana, United States, 47401
United States, Iowa
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Iowa City, Iowa, United States, 52242
United States, Kentucky
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Lexington, Kentucky, United States, 40503
United States, Maryland
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Silver Spring, Maryland, United States, 20910
United States, Massachusetts
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Worcester, Massachusetts, United States, 01655
United States, Michigan
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Detroit, Michigan, United States, 48201
United States, Minnesota
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St. Paul, Minnesota, United States, 55102
United States, Missouri
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Columbia, Missouri, United States, 65201
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Kansas City, Missouri, United States, 64111
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St. Louis, Missouri, United States, 63104
United States, Nevada
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Las Vegas, Nevada, United States, 89128
United States, New Jersey
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Hackensack, New Jersey, United States, 07601
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Livingston, New Jersey, United States, 07052
United States, New York
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Buffalo, New York, United States, 14222
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New York, New York, United States, 10003
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New York, New York, United States, 10016
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New York, New York, United States, 10029
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Sleepy Hollow, New York, United States, 10591
United States, Ohio
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Cincinnati, Ohio, United States, 45229
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Toledo, Ohio, United States, 43606
United States, Pennsylvania
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Hershey, Pennsylvania, United States, 17033
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Philadelphia, Pennsylvania, United States, 19134
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Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
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Greenville, South Carolina, United States, 29615
United States, South Dakota
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Rapid City, South Dakota, United States, 57701
United States, Tennessee
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Memphis, Tennessee, United States, 38103-2800
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Memphis, Tennessee, United States, 38119
United States, Texas
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Dallas, Texas, United States, 75235
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Edinburg, Texas, United States, 78539
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Fort Worth, Texas, United States, 76104
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Houston, Texas, United States, 77053
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Schertz, Texas, United States, 78154
United States, Virginia
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Norfolk, Virginia, United States, 23507
United States, West Virginia
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Charleston, West Virginia, United States, 25302
Australia, Queensland
Recruiting
Ipswich, Queensland, Australia, 4305
Austria
Recruiting
Graz, Austria, A 8036
Belgium
Recruiting
Brussels, Belgium, 1090
Canada, Manitoba
Recruiting
Winnipeg, Manitoba, Canada, R3E 3P4
Croatia
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Zagreb, Croatia, 10 000
Denmark
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Herlev, Denmark, 2730
France
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Marseille, France, 13006
Germany
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Mayen, Germany, 56727
Greece
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Goudi/ Athens, Greece, GR-11527
Hungary
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Budapest, Hungary, 1023
India
Recruiting
Bangalore, Karnataka, India, 560052
Israel
Recruiting
Jerusalem, Israel, 91240
Italy
Recruiting
Roma, Italy, 00165
Macedonia, The Former Yugoslav Republic of
Recruiting
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Mexico
Recruiting
Puebla, Mexico, 72190
New Zealand
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Grafton, New Zealand, 1142
Norway
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Bergen, Norway, 5021
Poland
Recruiting
Katowice, Poland, 40-752
Puerto Rico
Recruiting
Ponce, Puerto Rico, 00717
Romania
Recruiting
Bucharest, Romania, 020614
Russian Federation
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Moscow, Russian Federation, 117036
Serbia
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Belgrade, Serbia, 11070
Spain
Recruiting
Madrid, Spain, 28046
Sweden
Recruiting
Stockholm, Sweden, 141 86
Turkey
Recruiting
Ankara, Turkey, 06100
United Kingdom
Recruiting
Birmingham, United Kingdom, B4 6NH
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01541215     History of Changes
Other Study ID Numbers: NN2211-3659, 2011-002605-29, P/288/2010, U1111-1121-8743, CTRI/2013/10/004082
Study First Received: February 23, 2012
Last Updated: June 25, 2015
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Public Health Agency of Canada
Croatia: Ministry of Health and Social Care
Denmark: Danish Medicines Agency
France: Ministry of Health
Greece: Ministry of Health
Hungary: National Institute of Pharmacy
India: Ministry of Health and Family Wellfare
Israel: Israeli Health Ministry Pharmaceutical Administration
Macedonia, The Former Yugoslav Republic of: Ministry of Health
Mexico: National Institute of Public Health, Health Secretariat
New Zealand: Food Safety Authority
Norway: Norwegian Medicines Control Authority
Poland: Ministry of Health
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Russia: Federal Service for Control of Health Care and Social Development
Serbia: Agency for Drugs and Medicinal Devices
Spain: Spanish Agency of Medicines and Health Care Products
Sweden: Medical Products Agency
Turkey: Ministry of Health Drug and Pharmaceutical Department
United Kingdom: Medicines and Healthcare Products Regulatory
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Liraglutide
Metformin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 03, 2015