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 September 2014 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: September 17, 2014
Last verified: September 2014
  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: 172
Study Start Date: November 2012
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: December 2015 (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 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
  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

  Show 65 Study Locations
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: September 17, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
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
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
Norway: Norwegian Medicines Control Authority
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, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 30, 2014