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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 July 2021
• Main ID: NCT01541215
• Date of registration: 23/02/2012
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes Ellipse™
• Scientific title: Efficacy and Safety of Liraglutide in Combination With Metformin Versus Metformin Monotherapy on Glycaemic Control in Children and Adolescents With Type 2 Diabetes
• Date of first enrolment: November 13, 2012
• Target sample size: 135
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01541215
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Brazil, Canada, Croatia, Denmark, Egypt, France, Germany, Greece, Hungary, India, Israel, Italy, Lebanon, Macedonia, The Former Yugoslav Republic of, Malaysia, Mexico, Morocco, Netherlands, New Zealand, North Macedonia, Norway, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Serbia, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States

Key inclusion & exclusion 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



Age minimum: 10 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Diabetes

Intervention(s)

Drug: placebo

Drug: liraglutide

Drug: metformin

Primary Outcome(s)

Change in HbA1c (Glycosylated Haemoglobin) [Time Frame: Week 0, week 26]

Secondary Outcome(s)

Change From Baseline in Pulse [Time Frame: Week 0, week 26]

Change From Baseline in Pulse [Time Frame: Week 0, week 52]

Change in Blood Pressure (Systolic and Diastolic Blood Pressure) [Time Frame: Week 0, week 26]

Change in Blood Pressure (Systolic and Diastolic Blood Pressure) [Time Frame: Week 0, week 52]

Change From Baseline in 7-point Self-measured Plasma Glucose [Time Frame: Week 0, week 52]

Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 104 [Time Frame: Week 52, week 104]

Change From Baseline in Height SDS [Time Frame: Week 0, week 52]

Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner) [Time Frame: Week 0, week 52]

Change in Bone Age Assessment (X-ray of Left Hand and Wrist) [Time Frame: Week 0, week 52]

Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner) [Time Frame: Week 0, week 26]

Number of Adverse Events (Week 0-26) [Time Frame: 0-26 weeks]

Number of Serious Adverse Events (Week 53-104) [Time Frame: Weeks 53-104]

Number of Hypoglycaemic Episodes [Time Frame: 0-26 weeks]

Ratio to Baseline: Fasting Insulin [Time Frame: Week 0, week 26]

Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 [Time Frame: Week 52, week 104]

Growth (Height Velocity) [Time Frame: Week 0, week 26]

Number of Subjects Having HbA1c Below 7.5% [Time Frame: Week 26]

Ratio to Baseline: Fasting Glucagon [Time Frame: Week 0, week 26]

Ratio to Baseline: Fasting Insulin [Time Frame: Week 0, week 52]

Ratio to Baseline: Fasting Pro-insulin [Time Frame: Week 0, week 52]

Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner) [Time Frame: Week 0, week 26]

Growth (Height Velocity) [Time Frame: Week 0, week 52]

Height Velocity SDS [Time Frame: Week 0, week 26]

Change From Baseline in Body Weight [Time Frame: Week 0, week 52]

Change in FPG [Time Frame: Week 0, week 52]

Change in HbA1c [Time Frame: Week 0, week 52]

Growth (Height Velocity)- Week 156 [Time Frame: Week 0, week 156]

Change From Baseline in BMI Standard Deviation Score (SDS) [Time Frame: Week 0, week 52]

Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 [Time Frame: Week 52, week 156]

Change From Baseline in Fasting Plasma Glucose (FPG) [Time Frame: Week 0, week 26]

Change From Baseline in Height SDS [Time Frame: Week 0, week 26]

Height Velocity SDS [Time Frame: Week 0, week 52]

Number of Serious Adverse Events (Week 0-52) [Time Frame: 0-52 weeks]

Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner) [Time Frame: Week 0, week 52]

Height Velocity SDS- Week 104 [Time Frame: Week 0, week 104]

Ratio to Baseline: Free Fatty Acids [Time Frame: Week 0, week 26]

Number of Adverse Events (Week 0-52) [Time Frame: 0-52 weeks]

Number of Serious Adverse Events (Week 53-156) [Time Frame: Weeks 53-156]

Growth (Height Velocity)- Week 104 [Time Frame: Week 0, week 104]

Height Velocity SDS- Week 156 [Time Frame: Week 0, week 156]

Ratio to Baseline: Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR) [Time Frame: Week 0, week 26]

Ratio to Baseline: Fasting Pro-insulin [Time Frame: Week 0, week 26]

Ratio to Baseline: HOMA-B [Time Frame: Week 0, week 52]

Ratio to Baseline: Triglycerides [Time Frame: Week 0, week 52]

Ratio to Baseline: High-density Lipoprotein (HDL) Cholesterol [Time Frame: Week 0, week 26]

Number of Adverse Events (Week 53-104) [Time Frame: Week 53-104]

Number of Subjects Having HbA1c Below 7.0% [Time Frame: Week 26]

Ratio to Baseline: Pro-insulin/Insulin Ratio [Time Frame: Week 0, week 26]

Ratio to Baseline: Pro-insulin/Insulin Ratio [Time Frame: Week 0, week 52]

Ratio to Baseline: Total Cholesterol [Time Frame: Week 0, week 52]

Ratio to Baseline: Very Low-density Lipoprotein (VLDL) Cholesterol [Time Frame: Week 0, week 26]

Number of Subjects Having HbA1c Below 7.0% [Time Frame: Week 52]

Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes [Time Frame: Week 52]

Ratio to Baseline: Free Fatty Acids [Time Frame: Week 0, week 52]

Ratio to Baseline: Homeostasis Model Assessment of Beta-cell Function (HOMA-B) [Time Frame: Week 0, week 26]

Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS) [Time Frame: Week 0, week 26]

Change From Baseline in Body Weight [Time Frame: Week 0, week 26]

Change From Week 52 in Height SDS- Week 104 [Time Frame: Week 52, week 104]

Change From Week 52 in Height SDS- Week 156 [Time Frame: Week 52, week 156]

Ratio to Baseline: Total Cholesterol [Time Frame: Week 0, week 26]

Number of Adverse Events (Week 53-156) [Time Frame: Week 53-156]

Number of Hypoglycaemic Episodes [Time Frame: 0-52 weeks]

Number of Serious Adverse Events (Week 0-26) [Time Frame: 0-26 weeks]

Number of Subjects Having HbA1c Maximum 6.5% [Time Frame: Week 52]

Ratio to Baseline: Low Density Lipoprotein (LDL) Cholesterol [Time Frame: Week 0, week 26]

Ratio to Baseline: Triglycerides [Time Frame: Week 0, week 26]

Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 156 [Time Frame: Week 52, week 156]

Change in Mean 7-point Self-measured Plasma Glucose [Time Frame: Week 0, week 26]

Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes [Time Frame: Week 26]

Ratio to Baseline: Fasting C-peptide [Time Frame: Week 0, week 52]

Number of Subjects Having HbA1c Below 7.5% [Time Frame: Week 52]

Number of Subjects Having HbA1c Maximum 6.5% [Time Frame: Week 26]

Ratio to Baseline: HDL Cholesterol [Time Frame: Week 0, week 52]

Ratio to Baseline: HOMA-IR [Time Frame: Week 0, week 52]

Ratio to Baseline: LDL Cholesterol [Time Frame: Week 0, week 52]

Ratio to Baseline: VLDL Cholesterol [Time Frame: Week 0, week 52]

Pubertal Assessment/Progression (Tanner Staging) [Time Frame: Week 0, week 26, week 52]

Ratio to Baseline: Fasting C-peptide [Time Frame: Week 0, week 26]

Ratio to Baseline: Fasting Glucagon [Time Frame: Week 0, week 52]

Secondary ID(s)

U1111-1121-8743

CTRI/2013/10/004082

2011-002605-29

NN2211-3659

P/288/2010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/12/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01541215