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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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01541215
First received: February 23, 2012
Last updated: June 6, 2017
Last verified: June 2017
  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
Intervention Model: Parallel Assignment
Masking: Participant, 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 ]

Secondary Outcome Measures:
  • Number of subjects having HbA1c below 7.0% [ Time Frame: Week 26 ]
  • Number of subjects having HbA1c below 7.0% [ Time Frame: Week 52 ]
  • Number of subjects having HbA1c maximum 6.5% [ Time Frame: Week 26 ]
  • Number of subjects having HbA1c maximum 6.5% [ Time Frame: Week 52 ]
  • Number of subjects having HbA1c below 7.0% without severe or minor hypoglycaemic episodes [ Time Frame: Week 26 ]
  • Number of subjects having HbA1c below 7.0% without severe or minor hypoglycaemic episodes [ Time Frame: Week 52 ]
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Week 0, week 26 ]
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Week 0, week 52 ]
  • Change from baseline in 7-point self-measured plasma glucose [ Time Frame: Week 0, week 26 ]
  • Change from baseline in 7-point self-measured plasma glucose [ Time Frame: Week 0, week 52 ]
  • Change from baseline in body weight [ Time Frame: Week 0, week 26 ]
  • Change from baseline in body weight [ Time Frame: Week 0, week 52 ]
  • Change from baseline in BMI standard deviation score (SDS) [ Time Frame: Week 0, week 26 ]
  • Change from baseline in BMI standard deviation score (SDS) [ Time Frame: Week 0, week 52 ]
  • Number of adverse events (AEs) [ Time Frame: Week 26 ]
  • Number of adverse events (AEs) [ Time Frame: Week 52 ]
  • Number of adverse events (AEs) [ Time Frame: week 104 (1 year follow-up) ]
  • Number of adverse events (AEs) [ Time Frame: Week 156 (2 year follow-up) ]
  • Number of serious adverse events (SAEs) [ Time Frame: Week 26 ]
  • Number of serious adverse events (SAEs) [ Time Frame: Week 52 ]
  • Number of serious adverse events (SAEs) [ Time Frame: Week 104 (1 year follow-up) ]
  • Number of serious adverse events (SAEs) [ Time Frame: Week 156 (2 year follow-up ) ]
  • Growth velocity [ Time Frame: Week 104 (1 year follow-up) ]
  • Growth velocity [ Time Frame: Week 156 (2 year follow-up) ]
  • Pubertal progression [ Time Frame: Week 104 (1 year follow-up) ]
  • Pubertal progression [ Time Frame: Week 156 (2 year follow-up) ]

Estimated Enrollment: 150
Actual Study Start Date: November 12, 2012
Estimated Study Completion Date: June 29, 2020
Estimated Primary Completion Date: June 28, 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 17 Years   (Child)
Sexes Eligible for Study:   All
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

  Show 185 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01541215     History of Changes
Other Study ID Numbers: NN2211-3659
2011-002605-29 ( EudraCT Number )
P/288/2010 ( Other Identifier: EMA (PDCO) )
U1111-1121-8743 ( Other Identifier: WHO )
CTRI/2013/10/004082 ( Registry Identifier: Clinical Trials Registry - India (CTRI) )
Study First Received: February 23, 2012
Last Updated: June 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

ClinicalTrials.gov processed this record on July 21, 2017