Phase 3
Completed N=135
Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01541215 ↗Enrolled (actual)
135
Serious AEs
9.4%
Results posted
Dec 2018
Primary outcomePrimary: Change in HbA1c (Glycosylated Haemoglobin) — -0.643; 0.415 Percentage of HbA1c — p=<0.001
◆ Published Evidence
Highly cited
345citations · ~49 / year
Liraglutide in Children and Adolescents with Type 2 Diabetes.
Summary
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.
Linked Publications (2)
-
Liraglutide in Children and Adolescents with Type 2 Diabetes.
-
Effect of liraglutide treatment on body mass index and weight parameters in children and adolescents with type 2 diabetes: Post hoc analysis of the ellipse trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c (Glycosylated Haemoglobin) |
-0.643; 0.415 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) |
-1.076; 0.801 | 0.002 sig |
| SECONDARY Number of Subjects Having HbA1c Below 7.0% |
27; 16; 29; 36 | — |
| SECONDARY Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS) |
-0.254; -0.208 | 0.392 |
| SECONDARY Number of Subjects Having HbA1c Below 7.0% |
27; 16; 29; 36 | — |
| SECONDARY Number of Subjects Having HbA1c Maximum 6.5% |
25; 13; 31; 39 | — |
| SECONDARY Number of Subjects Having HbA1c Maximum 6.5% |
25; 13; 31; 39 | — |
| SECONDARY Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes |
22; 16; 34; 36 | — |
| SECONDARY Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes |
22; 16; 34; 36 | — |
| SECONDARY Number of Subjects Having HbA1c Below 7.5% |
36; 23; 20; 29 | — |
| SECONDARY Number of Subjects Having HbA1c Below 7.5% |
36; 23; 20; 29 | — |
| SECONDARY Change in HbA1c |
-0.732; 0.677 | — |
| SECONDARY Change in FPG |
-1.627; 0.983 | — |
| SECONDARY Change in Mean 7-point Self-measured Plasma Glucose |
-2.384; 0.198 | — |
| SECONDARY Change From Baseline in 7-point Self-measured Plasma Glucose |
-2.309; -0.748 | — |
| SECONDARY Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner) |
-1.802; 0.053; -0.735; -1.219; -0.028; -0.195 | — |
| SECONDARY Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner) |
-1.802; 0.053; -0.735; -1.219; -0.028; -0.195 | — |
| SECONDARY Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner) |
-0.747; -0.397 | — |
| SECONDARY Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner) |
-0.747; -0.397 | — |
| SECONDARY Change From Baseline in Body Weight |
-2.27; 1.02 | — |
| SECONDARY Change From Baseline in Body Weight |
-2.27; 1.02 | — |
| SECONDARY Change From Baseline in BMI Standard Deviation Score (SDS) |
-0.361; -0.166 | — |
| SECONDARY Change in Blood Pressure (Systolic and Diastolic Blood Pressure) |
-0.77; 2.81; 0.46; 1.83 | — |
| SECONDARY Change in Blood Pressure (Systolic and Diastolic Blood Pressure) |
-0.77; 2.81; 0.46; 1.83 | — |
| SECONDARY Ratio to Baseline: Fasting Insulin |
1.0; 1.1 | — |
| SECONDARY Ratio to Baseline: Fasting Insulin |
1.0; 1.1 | — |
| SECONDARY Ratio to Baseline: Fasting Pro-insulin |
0.62; 0.79 | — |
| SECONDARY Ratio to Baseline: Fasting Pro-insulin |
0.62; 0.79 | — |
| SECONDARY Ratio to Baseline: Pro-insulin/Insulin Ratio |
0.689; 0.770 | — |
| SECONDARY Ratio to Baseline: Pro-insulin/Insulin Ratio |
0.689; 0.770 | — |
| SECONDARY Ratio to Baseline: Fasting Glucagon |
1.01; 1.05 | — |
| SECONDARY Ratio to Baseline: Fasting Glucagon |
1.01; 1.05 | — |
| SECONDARY Ratio to Baseline: Fasting C-peptide |
0.94; 0.83 | — |
| SECONDARY Ratio to Baseline: Fasting C-peptide |
0.94; 0.83 | — |
| SECONDARY Ratio to Baseline: Homeostasis Model Assessment of Beta-cell Function (HOMA-B) |
1.24; 1.01 | — |
| SECONDARY Ratio to Baseline: HOMA-B |
1.48; 0.93 | — |
| SECONDARY Ratio to Baseline: Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR) |
0.73; 0.98 | — |
| SECONDARY Ratio to Baseline: HOMA-IR |
0.82; 1.08 | — |
| SECONDARY Ratio to Baseline: Total Cholesterol |
1.013; 1.026 | — |
| SECONDARY Ratio to Baseline: Total Cholesterol |
1.013; 1.026 | — |
| SECONDARY Ratio to Baseline: Low Density Lipoprotein (LDL) Cholesterol |
0.998; 0.993 | — |
| SECONDARY Ratio to Baseline: LDL Cholesterol |
1.042; 1.035 | — |
| SECONDARY Ratio to Baseline: Very Low-density Lipoprotein (VLDL) Cholesterol |
0.890; 1.035 | — |
| SECONDARY Ratio to Baseline: VLDL Cholesterol |
0.983; 1.003 | — |
| SECONDARY Ratio to Baseline: High-density Lipoprotein (HDL) Cholesterol |
0.997; 0.981 | — |
| SECONDARY Ratio to Baseline: HDL Cholesterol |
1.028; 1.000 | — |
| SECONDARY Ratio to Baseline: Triglycerides |
0.964; 1.036 | — |
| SECONDARY Ratio to Baseline: Triglycerides |
0.964; 1.036 | — |
| SECONDARY Ratio to Baseline: Free Fatty Acids |
0.928; 0.868 | — |
| SECONDARY Ratio to Baseline: Free Fatty Acids |
0.928; 0.868 | — |
| SECONDARY Change From Baseline in Pulse |
-0.05; -0.28 | — |
| SECONDARY Change From Baseline in Pulse |
-0.05; -0.28 | — |
| SECONDARY Change From Baseline in Height SDS |
-0.192; -0.134 | — |
| SECONDARY Change From Baseline in Height SDS |
-0.192; -0.134 | — |
| SECONDARY Change in Bone Age Assessment (X-ray of Left Hand and Wrist) |
1.197; 1.088 | — |
| SECONDARY Pubertal Assessment/Progression (Tanner Staging) |
1; 0; 2; 0; 4; 10 | — |
| SECONDARY Growth (Height Velocity) |
1.345; 1.817 | — |
| SECONDARY Growth (Height Velocity) |
1.345; 1.817 | — |
| SECONDARY Height Velocity SDS |
-0.887; -0.551 | — |
| SECONDARY Height Velocity SDS |
-0.887; -0.551 | — |
| SECONDARY Number of Hypoglycaemic Episodes |
160; 63 | — |
| SECONDARY Number of Hypoglycaemic Episodes |
160; 63 | — |
| SECONDARY Number of Adverse Events (Week 0-26) |
310; 230 | — |
| SECONDARY Number of Adverse Events (Week 0-52) |
426; 321 | — |
| SECONDARY Number of Serious Adverse Events (Week 0-26) |
7; 4 | — |
| SECONDARY Number of Serious Adverse Events (Week 0-52) |
10; 5 | — |
| SECONDARY Number of Adverse Events (Week 53-104) |
30 | — |
| SECONDARY Number of Serious Adverse Events (Week 53-104) |
7 | — |
| SECONDARY Growth (Height Velocity)- Week 104 |
1.149 | — |
| SECONDARY Height Velocity SDS- Week 104 |
-0.523 | — |
| SECONDARY Change From Week 52 in Height SDS- Week 104 |
-0.133 | — |
| SECONDARY Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 |
0; 0; 1; 5; 21; 0 | — |
| SECONDARY Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 104 |
1.231 | — |
| SECONDARY Number of Adverse Events (Week 53-156) |
47 | — |
| SECONDARY Number of Serious Adverse Events (Week 53-156) |
9 | — |
| SECONDARY Growth (Height Velocity)- Week 156 |
1.100 | — |
| SECONDARY Height Velocity SDS- Week 156 |
0.142 | — |
| SECONDARY Change From Week 52 in Height SDS- Week 156 |
-0.224 | — |
| SECONDARY Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 |
0; 0; 1; 5; 21; 0 | — |
| SECONDARY Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 156 |
1.778 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01541215) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.