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

February 23, 2012
June 25, 2015
November 2012
June 2018   (final data collection date for primary outcome measure)
Change in HbA1c (glycosylated haemoglobin) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
Change in HbA1c (glycosylated haemoglobin) [ Time Frame: Week 0, week 14 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01541215 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Number of subjects having HbA1c below 7.0% [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
  • 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 14 ] [ 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 14 ] [ 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 14 ] [ 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 14 ] [ 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 ]
  • Number of adverse events (AEs) [ Time Frame: Week 53 ] [ 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 53 ] [ Designated as safety issue: No ]
  • Number of adverse events (AEs) [ 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 ]
Not Provided
Not Provided
 
Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes
Efficacy and Safety of Liraglutide in Combination With Metformin Versus Metformin Monotherapy on Glycaemic Control in Children and Adolescents With Type 2 Diabetes

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • 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.
  • Experimental: Lira + Met
    Interventions:
    • Drug: liraglutide
    • Drug: metformin
  • Placebo Comparator: Placebo + Met
    Interventions:
    • Drug: placebo
    • Drug: metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
June 2020
June 2018   (final data collection date for primary outcome measure)

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
Both
10 Years to 16 Years
No
Contact: Novo Nordisk clinicaltrials@novonordisk.com
United States,   Australia,   Austria,   Belgium,   Canada,   Croatia,   Denmark,   France,   Germany,   Greece,   Hungary,   India,   Israel,   Italy,   Macedonia, The Former Yugoslav Republic of,   Mexico,   New Zealand,   Norway,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Serbia,   Spain,   Sweden,   Turkey,   United Kingdom
Brazil
 
NCT01541215
NN2211-3659, 2011-002605-29, P/288/2010, U1111-1121-8743, CTRI/2013/10/004082
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP