Phase 3 · Liraglutide

Ellipse trial results

Efficacy and Safety of Liraglutide in Combination With Metformin Versus Metformin Monotherapy on Glycaemic Control in Children and Adolescents With Type 2 Diabetes

Change in HbA1c (Glycosylated Haemoglobin) (Percentage of HbA1c), Week 0, week 26. Liraglutide 1.8 mg: -0.643; Placebo: 0.415.

Participants
135
Status
completed
Completed
2020-05-20
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT01541215), updated at source Jul 2, 2021. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What Ellipse measured first

Change in HbA1c (Glycosylated Haemoglobin)Percentage of HbA1c · Week 0, week 26 · least squares mean
Liraglutide 1.8 mgn=66Placebon=68
-0.643(0.215)0.415(0.216)
Side effects by arm

Side effects in Ellipse

Percent of participants affected, Week 0 - 156. All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of.... The most common events the registry lists.

EventLiraglutide 1.8 mgPlaceboLiraglutide 1.8 mg: Follow-up 1Liraglutide 1.8 mg: Follow-up 2
Any serious event13.6%5.9%13.5%4.2%
Nausea28.8%13.2%1.9%0%
Nasopharyngitis16.7%27.9%3.8%0%
Vomiting25.8%8.8%3.8%0%
Diarrhoea22.7%16.2%0%0%
Headache21.2%19.1%0%0%
Abdominal pain16.7%7.4%1.9%0%
Dizziness12.1%2.9%0%0%
Abdominal pain upper3%11.8%0%0%
Gastroenteritis10.6%2.9%0%0%
Upper respiratory tract infection9.1%7.4%0%0%
Dysmenorrhoea4.5%8.8%0%0%
Influenza6.1%8.8%0%0%
Oropharyngeal pain6.1%8.8%0%0%
Dyspepsia7.6%1.5%1.9%0%
Pyrexia6.1%7.4%0%0%
Constipation6.1%1.5%1.9%0%
Cough6.1%5.9%0%0%
Decreased appetite6.1%4.4%0%0%
Hyperglycaemia6.1%5.9%1.9%2.1%
Pharyngitis6.1%5.9%0%2.1%
Rash6.1%1.5%0%0%
Alanine aminotransferase increased0%5.9%0%0%
Rhinorrhoea1.5%5.9%0%0%
Secondary outcomes

What else it measured

Change From Baseline in Fasting Plasma Glucose (FPG)mmol/L · Week 0, week 26 · least squares mean
Liraglutide 1.8 mgn=66Placebon=68
-1.076(0.436)0.801(0.449)
Number of Subjects Having HbA1c Below 7.0%Percentage of subjects · Week 26 · number
Liraglutide 1.8 mgn=66Placebon=68
63.736.5
Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS)SDS score · Week 0, week 26 · least squares mean
Liraglutide 1.8 mgn=66Placebon=68
-0.254(0.039)-0.208(0.039)
Number of Subjects Having HbA1c Below 7.0%Participants · Week 52 · count of participants
MeasureLiraglutide 1.8 mgn=56Placebon=52
Yes2716
No2936
Number of Subjects Having HbA1c Maximum 6.5%Participants · Week 26 · count of participants
MeasureLiraglutide 1.8 mgn=59Placebon=58
Yes2819
No3139
Number of Subjects Having HbA1c Maximum 6.5%Participants · Week 52 · count of participants
MeasureLiraglutide 1.8 mgn=56Placebon=52
Yes2513
No3139
Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic EpisodesParticipants · Week 26 · count of participants
MeasureLiraglutide 1.8 mgn=59Placebon=58
Yes3121
No2837
Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic EpisodesParticipants · Week 52 · count of participants
MeasureLiraglutide 1.8 mgn=56Placebon=52
Yes2216
No3436
Number of Subjects Having HbA1c Below 7.5%Participants · Week 26 · count of participants
MeasureLiraglutide 1.8 mgn=59Placebon=58
Yes4329
No1629
Number of Subjects Having HbA1c Below 7.5%Participants · Week 52 · count of participants
MeasureLiraglutide 1.8 mgn=56Placebon=52
Yes3623
No2029
Change in HbA1cpercentage of HbA1c · Week 0, week 52 · mean
Liraglutide 1.8 mgn=56Placebon=52
-0.732(1.423)0.677(1.523)
Change in FPGmmol/L · Week 0, week 52 · mean
Liraglutide 1.8 mgn=56Placebon=53
-1.627(2.717)0.983(3.954)
The trial

How Ellipse was run

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.

  • Lira + Met
  • Placebo + Met
Who could join the trial

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

Published papers

Papers from Ellipse

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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