Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief 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.
Interventions
DRUGliraglutide
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.
DRUGplacebo
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.
DRUGmetformin
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.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c (Glycosylated Haemoglobin) | Week 0, week 26 | Change in HbA1c from baseline to week 26. All available data were used for the primary analysis, including data collected after treatment discontinuation and initiation of rescue medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Having HbA1c Below 7.0% | Week 26 | Percentage of subjects having HbA1c \<7.0%. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS) | Week 0, week 26 | Change in BMI SDS from baseline to week 26. BMI SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (WHO) Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Number of Subjects Having HbA1c Maximum 6.5% | Week 26 | Number of subjects achieving HbA1c \<=6.5% after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes | Week 26 | Number of subjects achieving HbA1c \<7.0% without severe or minor hypoglycaemic episodes after 26 weeks. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemia was defined as meeting either of the below criteria: 1. an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose \<2.8 mmol/L (50 mg/dL) or plasma glucose \<3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself 2. any asymptomatic blood glucose value \<2.8 mmol/L (50 mg/dL) or plasma glucose value \<3.1 mmol/L (56 mg/dL) All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Number of Subjects Having HbA1c Below 7.5% | Week 26 | Number of subjects achieving HbA1c \<7.5% after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Change in HbA1c | Week 0, week 52 | Change in HbA1c from baseline to week 52. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication. |
| Change in FPG | Week 0, week 52 | Change in FPG from baseline to week 52. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication. |
| Change in Mean 7-point Self-measured Plasma Glucose | Week 0, week 26 | Change in mean 7-point self-measured plasma glucose after 26 weeks. Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Mean 7-point SMPG was defined as the area under the profile (calculated using the trapezoidal method) divided by time. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Change From Baseline in 7-point Self-measured Plasma Glucose | Week 0, week 52 | Change in mean 7-point self-measured plasma glucose after 52 weeks. Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Mean 7-point SMPG was defined as the area under the profile (calculated using the trapezoidal method) divided by time. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner) | Week 0, week 26 | Change in post-prandial increments (from before meal to 90 min after breakfast, lunch, and dinner) after 26 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner) | Week 0, week 26 | Change in mean post-prandial increment across all three meals (breakfast, lunch, and dinner) after 26 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Change From Baseline in Body Weight | Week 0, week 26 | Change from baseline in body weight after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Change From Baseline in BMI Standard Deviation Score (SDS) | Week 0, week 52 | Change in BMI SDS from baseline to week 52. BMI SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Week 0, week 26 | Change in blood pressure (systolic and diastolic blood pressure) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Ratio to Baseline: Fasting Insulin | Week 0, week 26 | Ratio to baseline (fasting insulin) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Ratio to Baseline: Fasting Pro-insulin | Week 0, week 26 | Ratio to baseline (fasting pro-insulin) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Ratio to Baseline: Pro-insulin/Insulin Ratio | Week 0, week 26 | Ratio to baseline (Pro-insulin/insulin ratio) after week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Ratio to Baseline: Fasting Glucagon | Week 0, week 26 | Ratio to baseline (fasting glucagon) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Ratio to Baseline: Fasting C-peptide | Week 0, week 26 | Ratio to baseline (fasting C-peptide) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Ratio to Baseline: Homeostasis Model Assessment of Beta-cell Function (HOMA-B) | Week 0, week 26 | Ratio to baseline (HOMA-B) after 26 weeks. HOMA-B is an index of beta-cell function and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Ratio to Baseline: HOMA-B | Week 0, week 52 | Ratio to baseline (HOMA-B) after 52 weeks. HOMA-B is an index of beta-cell function and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Ratio to Baseline: Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR) | Week 0, week 26 | Ratio to baseline (HOMA-IR) after 26 weeks. HOMA-IR is an index of insulin resistance and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Ratio to Baseline: HOMA-IR | Week 0, week 52 | Ratio to baseline (HOMA-IR) after 52 weeks. HOMA-IR is an index of insulin resistance and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Ratio to Baseline: Total Cholesterol | Week 0, week 26 | Ratio to baseline (total cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Ratio to Baseline: Low Density Lipoprotein (LDL) Cholesterol | Week 0, week 26 | Ratio to baseline (LDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Ratio to Baseline: LDL Cholesterol | Week 0, week 52 | Ratio to baseline (LDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Ratio to Baseline: Very Low-density Lipoprotein (VLDL) Cholesterol | Week 0, week 26 | Ratio to baseline (VLDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Ratio to Baseline: VLDL Cholesterol | Week 0, week 52 | Ratio to baseline (VLDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Ratio to Baseline: High-density Lipoprotein (HDL) Cholesterol | Week 0, week 26 | Ratio to baseline (HDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Ratio to Baseline: HDL Cholesterol | Week 0, week 52 | Ratio to baseline (HDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Ratio to Baseline: Triglycerides | Week 0, week 26 | Ratio to baseline (triglycerides) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Ratio to Baseline: Free Fatty Acids | Week 0, week 26 | Ratio to baseline (free fatty acids) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Change From Baseline in Pulse | Week 0, week 26 | Change from baseline in pulse 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Change From Baseline in Height SDS | Week 0, week 26 | Change in height SDS from baseline to week 26. Height SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Change in Bone Age Assessment (X-ray of Left Hand and Wrist) | Week 0, week 52 | Change in bone age from baseline to week 52. If the baseline (week 0) bone age assessment indicated that all epiphyses were fused, then the assessment was not repeated at week 52. |
| Pubertal Assessment/Progression (Tanner Staging) | Week 0, week 26, week 52 | Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V. The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of participants at different Tanner stages at week 0, week 26 and week 52. |
| Growth (Height Velocity) | Week 0, week 26 | Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days. |
| Height Velocity SDS | Week 0, week 26 | Height velocity SDS scores at week 26. Height velocity is change in height per year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. |
| Number of Hypoglycaemic Episodes | 0-26 weeks | Total number of hypoglycaemic episodes according to American Diabetes Association (ADA) classification from baseline (week 0) to week 26. |
| Number of Adverse Events (Week 0-26) | 0-26 weeks | Total number of adverse events during 26 weeks. |
| Number of Adverse Events (Week 0-52) | 0-52 weeks | Total number of adverse events during entire treatment period. |
| Number of Serious Adverse Events (Week 0-26) | 0-26 weeks | Total number of serious adverse events during 26 weeks. |
| Number of Serious Adverse Events (Week 0-52) | 0-52 weeks | Total number of serious adverse events during entire treatment period. |
| Number of Adverse Events (Week 53-104) | Week 53-104 | This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. Number of adverse events reported during follow-up 1 (week 53 to 104). |
| Number of Serious Adverse Events (Week 53-104) | Weeks 53-104 | This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. Number of serious adverse events reported during follow up 1 (week 53 to 104). |
| Growth (Height Velocity)- Week 104 | Week 0, week 104 | Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. |
| Height Velocity SDS- Week 104 | Week 0, week 104 | The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. |
| Change From Week 52 in Height SDS- Week 104 | Week 52, week 104 | Change in height SDS from week 52 to week 104. Height SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. |
| Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Week 52, week 104 | Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V, where stage I represents pre-adoloscent development and stage V represents pubertal development equivalent to that of an adult. The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of subjects at different Tanner stages at week 52 and week 104. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. |
| Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 104 | Week 52, week 104 | Change in bone age from week 52 to week 104. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. |
| Change From Baseline in Fasting Plasma Glucose (FPG) | Week 0, week 26 | Change in FPG from baseline to week 26. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication. |
| Number of Serious Adverse Events (Week 53-156) | Weeks 53-156 | This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. Number of serious adverse events reported during the follow up period (week 53 to 156). |
| Growth (Height Velocity)- Week 156 | Week 0, week 156 | Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. |
| Height Velocity SDS- Week 156 | Week 0, week 156 | The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. |
| Change From Week 52 in Height SDS- Week 156 | Week 52, week 156 | Change in height SDS from week 52 to week 156. Height SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. |
| Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Week 52, week 156 | Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V, where stage I represents pre-adoloscent development and stage V represents pubertal development equivalent to that of an adult. The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of subjects at different Tanner stages at week 52 and week 156. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. |
| Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 156 | Week 52, week 156 | Change in bone age from week 52 to week 156. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. |
| Number of Adverse Events (Week 53-156) | Week 53-156 | This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. Number of adverse events reported during the follow-up period (weeks 53 to 156). |
Countries
Australia, Austria, Belgium, Brazil, Canada, Croatia, Denmark, Egypt, France, Germany, Greece, Hungary, India, Israel, Italy, Lebanon, Malaysia, Mexico, Morocco, Netherlands, New Zealand, North Macedonia, Norway, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Participant flow
Recruitment details
The trial was conducted at 84 sites in 25 countries.
Pre-assignment details
Eligible subjects entered an 11- to 12-week run-in period where they were to undergo a 3-4 week titration of metformin to a maximum tolerated dose of metformin (≥1000 mg and ≤2000 mg per day) followed by an 8-week maintenance period.
Participants by arm
| Arm | Count |
|---|---|
| Liraglutide 1.8 mg After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52). | 66 |
| Placebo After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period. | 68 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow up 1 (Weeks 53-104) | Lost to Follow-up | 1 | 0 |
| Follow up 1 (Weeks 53-104) | Withdrawal by Subject | 1 | 0 |
| Treatment Period (52 Weeks) | Adverse Event | 0 | 1 |
| Treatment Period (52 Weeks) | Non-compliance | 4 | 4 |
| Treatment Period (52 Weeks) | Unclassified | 0 | 3 |
| Treatment Period (52 Weeks) | Withdrawal criteria | 6 | 8 |
Baseline characteristics
| Characteristic | Liraglutide 1.8 mg | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 14.57 years STANDARD_DEVIATION 1.73 | 14.57 years STANDARD_DEVIATION 1.73 | 14.57 years STANDARD_DEVIATION 1.72 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 23 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 45 Participants | 95 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Glycosylated hemoglobin (HbA1c) | 7.87 percentage of HbA1c STANDARD_DEVIATION 1.35 | 7.69 percentage of HbA1c STANDARD_DEVIATION 1.34 | 7.78 percentage of HbA1c STANDARD_DEVIATION 1.34 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 8 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 7 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 7 Participants | 10 Participants |
| Race (NIH/OMB) White | 42 Participants | 45 Participants | 87 Participants |
| Sex: Female, Male Female | 41 Participants | 42 Participants | 83 Participants |
| Sex: Female, Male Male | 25 Participants | 26 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 66 | 0 / 68 | 0 / 52 | 0 / 48 |
| other Total, other adverse events | 45 / 66 | 49 / 68 | 7 / 52 | 1 / 48 |
| serious Total, serious adverse events | 9 / 66 | 4 / 68 | 7 / 52 | 2 / 48 |
Outcome results
Primary
Change in HbA1c (Glycosylated Haemoglobin)
Change in HbA1c from baseline to week 26. All available data were used for the primary analysis, including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 26
Population: Full analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Change in HbA1c (Glycosylated Haemoglobin) | -0.643 Percentage of HbA1c | Standard Error 0.215 |
| Placebo | Change in HbA1c (Glycosylated Haemoglobin) | 0.415 Percentage of HbA1c | Standard Error 0.216 |
Comparison: Analysis using a pattern mixture model of observed data with missing observations imputed from the placebo arm based on multiple (x10.000) imputations. The data for week 26 were then analysed with an ANCOVA model containing treatment, sex and age group as fixed effects and baseline value as covariate. The estimated treatment differences and confidence intervals were combined using Rubins formula.p-value: <0.00195% CI: [-1.653, -0.464]Pattern Mixture Model
Secondary
Change From Baseline in 7-point Self-measured Plasma Glucose
Change in mean 7-point self-measured plasma glucose after 52 weeks. Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Mean 7-point SMPG was defined as the area under the profile (calculated using the trapezoidal method) divided by time. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 52
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Change From Baseline in 7-point Self-measured Plasma Glucose | -2.309 mmol/L | Standard Deviation 2.968 |
| Placebo | Change From Baseline in 7-point Self-measured Plasma Glucose | -0.748 mmol/L | Standard Deviation 1.944 |
Secondary
Change From Baseline in BMI Standard Deviation Score (SDS)
Change in BMI SDS from baseline to week 52. BMI SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 52
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Change From Baseline in BMI Standard Deviation Score (SDS) | -0.361 SDS score | Standard Deviation 0.542 |
| Placebo | Change From Baseline in BMI Standard Deviation Score (SDS) | -0.166 SDS score | Standard Deviation 0.33 |
Secondary
Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS)
Change in BMI SDS from baseline to week 26. BMI SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (WHO) Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 26
Population: Full analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS) | -0.254 SDS score | Standard Error 0.039 |
| Placebo | Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS) | -0.208 SDS score | Standard Error 0.039 |
Comparison: Analysis using a pattern mixture model of observed data with missing observations imputed from the placebo arm based on multiple (x10.000) imputations. The data for weeks 26 were then analysed with an ANCOVA model containing treatment, sex and age group as fixed effects and baseline value as covariate. The estimated treatment differences and confidence intervals were combined using Rubins formula.p-value: 0.39295% CI: [-0.153, 0.06]Pattern Mixture Model
Secondary
Change From Baseline in Body Weight
Change from baseline in body weight after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 26
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Change From Baseline in Body Weight | -2.48 kg | Standard Deviation 5.59 |
| Placebo | Change From Baseline in Body Weight | -0.87 kg | Standard Deviation 3.84 |
Secondary
Change From Baseline in Body Weight
Change from baseline in body weight after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 52
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Change From Baseline in Body Weight | -2.27 kg | Standard Deviation 8.05 |
| Placebo | Change From Baseline in Body Weight | 1.02 kg | Standard Deviation 4.64 |
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG)
Change in FPG from baseline to week 26. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 26
Population: Full analysis set.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Change From Baseline in Fasting Plasma Glucose (FPG) | -1.076 mmol/L | Standard Error 0.436 |
| Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) | 0.801 mmol/L | Standard Error 0.449 |
Comparison: Analysis using a pattern mixture model of observed data with missing observations imputed from the placebo arm based on multiple (x10.000) imputations. The data for weeks 26 were then analysed with an ANCOVA model containing treatment, sex and age group as fixed effects and baseline value as covariate. The estimated treatment differences and confidence intervals were combined using Rubins formula.p-value: 0.00295% CI: [-3.093, -0.662]Pattern Mixture Model
Secondary
Change From Baseline in Height SDS
Change in height SDS from baseline to week 52. Height SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 52
Population: Safety analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Change From Baseline in Height SDS | -0.192 SDS score | Standard Deviation 0.223 |
| Placebo | Change From Baseline in Height SDS | -0.134 SDS score | Standard Deviation 0.293 |
Secondary
Change From Baseline in Height SDS
Change in height SDS from baseline to week 26. Height SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 26
Population: Safety analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Change From Baseline in Height SDS | -0.100 SDS score | Standard Deviation 0.133 |
| Placebo | Change From Baseline in Height SDS | -0.042 SDS score | Standard Deviation 0.21 |
Secondary
Change From Baseline in Pulse
Change from baseline in pulse 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 26
Population: Safety analysis set - included all subjects receiving at least one dose of liraglutide/placebo (134 subjects). Number of participants analysed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Change From Baseline in Pulse | 1.40 beats/minute | Standard Deviation 10.89 |
| Placebo | Change From Baseline in Pulse | 0.33 beats/minute | Standard Deviation 7.69 |
Secondary
Change From Baseline in Pulse
Change from baseline in pulse 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 52
Population: Safety analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Change From Baseline in Pulse | -0.05 beats/minute | Standard Deviation 10.39 |
| Placebo | Change From Baseline in Pulse | -0.28 beats/minute | Standard Deviation 7.88 |
Secondary
Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 104
Change in bone age from week 52 to week 104. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.
Time frame: Week 52, week 104
Population: Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-104. Overall number of participants analyzed= subjects with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 104 | 1.231 Years | Standard Deviation 0.992 |
Secondary
Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 156
Change in bone age from week 52 to week 156. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.
Time frame: Week 52, week 156
Population: Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-156. Overall number of participants analyzed= subjects with available data at week 156.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 156 | 1.778 Years | Standard Deviation 1.277 |
Secondary
Change From Week 52 in Height SDS- Week 104
Change in height SDS from week 52 to week 104. Height SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.
Time frame: Week 52, week 104
Population: Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-104. Overall number of participants analyzed= subjects with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Change From Week 52 in Height SDS- Week 104 | -0.133 SDS score | Standard Deviation 0.338 |
Secondary
Change From Week 52 in Height SDS- Week 156
Change in height SDS from week 52 to week 156. Height SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.
Time frame: Week 52, week 156
Population: Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-156. Overall number of participants analyzed= subjects with available data at week 156.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Change From Week 52 in Height SDS- Week 156 | -0.224 SDS score | Standard Deviation 0.446 |
Secondary
Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
Change in blood pressure (systolic and diastolic blood pressure) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 26
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 1.8 mg | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Systolic Blood Pressure | -1.65 mmHg | Standard Deviation 10.69 |
| Liraglutide 1.8 mg | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Diastolic Blood Pressure | -1.27 mmHg | Standard Deviation 8.39 |
| Placebo | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Systolic Blood Pressure | 0.03 mmHg | Standard Deviation 10.05 |
| Placebo | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Diastolic Blood Pressure | 0.97 mmHg | Standard Deviation 7.65 |
Secondary
Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
Change in blood pressure (systolic and diastolic blood pressure) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 52
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 1.8 mg | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Systolic Blood Pressure | -0.77 mmHg | Standard Deviation 11.77 |
| Liraglutide 1.8 mg | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Diastolic Blood Pressure | 0.46 mmHg | Standard Deviation 10.01 |
| Placebo | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Systolic Blood Pressure | 2.81 mmHg | Standard Deviation 8.48 |
| Placebo | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Diastolic Blood Pressure | 1.83 mmHg | Standard Deviation 7.26 |
Secondary
Change in Bone Age Assessment (X-ray of Left Hand and Wrist)
Change in bone age from baseline to week 52. If the baseline (week 0) bone age assessment indicated that all epiphyses were fused, then the assessment was not repeated at week 52.
Time frame: Week 0, week 52
Population: Safety analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Change in Bone Age Assessment (X-ray of Left Hand and Wrist) | 1.197 years | Standard Deviation 0.899 |
| Placebo | Change in Bone Age Assessment (X-ray of Left Hand and Wrist) | 1.088 years | Standard Deviation 0.889 |
Secondary
Change in FPG
Change in FPG from baseline to week 52. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 52
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Change in FPG | -1.627 mmol/L | Standard Deviation 2.717 |
| Placebo | Change in FPG | 0.983 mmol/L | Standard Deviation 3.954 |
Secondary
Change in HbA1c
Change in HbA1c from baseline to week 52. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 52
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Change in HbA1c | -0.732 percentage of HbA1c | Standard Deviation 1.423 |
| Placebo | Change in HbA1c | 0.677 percentage of HbA1c | Standard Deviation 1.523 |
Secondary
Change in Mean 7-point Self-measured Plasma Glucose
Change in mean 7-point self-measured plasma glucose after 26 weeks. Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Mean 7-point SMPG was defined as the area under the profile (calculated using the trapezoidal method) divided by time. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 26
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Change in Mean 7-point Self-measured Plasma Glucose | -2.384 mmol/L | Standard Deviation 2.638 |
| Placebo | Change in Mean 7-point Self-measured Plasma Glucose | 0.198 mmol/L | Standard Deviation 2.056 |
Secondary
Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)
Change in mean post-prandial increment across all three meals (breakfast, lunch, and dinner) after 52 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 52
Population: Full analysis set. Number of analysed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner) | -0.747 mmol/L | Standard Deviation 2.245 |
| Placebo | Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner) | -0.397 mmol/L | Standard Deviation 1.594 |
Secondary
Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)
Change in mean post-prandial increment across all three meals (breakfast, lunch, and dinner) after 26 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 26
Population: Full analysis set. Number of analysed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner) | -0.428 mmol/L | Standard Deviation 2.172 |
| Placebo | Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner) | -0.362 mmol/L | Standard Deviation 1.733 |
Secondary
Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)
Change in post-prandial increments (from before meal to 90 min after breakfast, lunch, and dinner) after 52 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 52
Population: Full analysis set. Number of analysed=participants with available data for specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 1.8 mg | Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner) | Breakfast | -1.802 mmol/L | Standard Deviation 3.338 |
| Liraglutide 1.8 mg | Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner) | Lunch | -0.735 mmol/L | Standard Deviation 3.809 |
| Liraglutide 1.8 mg | Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner) | Dinner | -0.028 mmol/L | Standard Deviation 3.501 |
| Placebo | Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner) | Breakfast | 0.053 mmol/L | Standard Deviation 2.124 |
| Placebo | Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner) | Lunch | -1.219 mmol/L | Standard Deviation 3.038 |
| Placebo | Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner) | Dinner | -0.195 mmol/L | Standard Deviation 2.803 |
Secondary
Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)
Change in post-prandial increments (from before meal to 90 min after breakfast, lunch, and dinner) after 26 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 26
Population: Full analysis set. Number of analysed=participants with available data for specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 1.8 mg | Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner) | Breakfast | -1.528 mmol/L | Standard Deviation 3.168 |
| Liraglutide 1.8 mg | Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner) | Lunch | -0.358 mmol/L | Standard Deviation 3.281 |
| Liraglutide 1.8 mg | Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner) | Dinner | 0.397 mmol/L | Standard Deviation 3.79 |
| Placebo | Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner) | Breakfast | -0.319 mmol/L | Standard Deviation 3.228 |
| Placebo | Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner) | Lunch | -0.658 mmol/L | Standard Deviation 3.421 |
| Placebo | Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner) | Dinner | -0.226 mmol/L | Standard Deviation 2.806 |
Secondary
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104
Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V, where stage I represents pre-adoloscent development and stage V represents pubertal development equivalent to that of an adult. The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of subjects at different Tanner stages at week 52 and week 104. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.
Time frame: Week 52, week 104
Population: Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-104. Number analyzed= subjects with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Female- Breast development- Week 52 | Stage I | 0 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Female- Breast development- Week 52 | Stage II | 0 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Female- Breast development- Week 52 | Stage III | 1 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Female- Breast development- Week 52 | Stage IV | 5 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Female- Breast development- Week 52 | Stage V | 21 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Female- Breast development- Week 104 | Stage I | 0 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Female- Breast development- Week 104 | Stage II | 0 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Female- Breast development- Week 104 | Stage III | 0 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Female- Breast development- Week 104 | Stage IV | 5 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Female- Breast development- Week 104 | Stage V | 11 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Male- Penis development- Week 52 | Stage I | 1 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Male- Penis development- Week 52 | Stage II | 2 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Male- Penis development- Week 52 | Stage III | 0 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Male- Penis development- Week 52 | Stage IV | 7 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Male- Penis development- Week 52 | Stage V | 14 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Male- Penis development- Week 104 | Stage I | 0 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Male- Penis development- Week 104 | Stage II | 1 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Male- Penis development- Week 104 | Stage III | 0 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Male- Penis development- Week 104 | Stage IV | 5 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Male- Penis development- Week 104 | Stage V | 8 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Female- Pubic hair development- Week 52 | Stage I | 0 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Female- Pubic hair development- Week 52 | Stage II | 0 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Female- Pubic hair development- Week 52 | Stage III | 2 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Female- Pubic hair development- Week 52 | Stage IV | 2 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Female- Pubic hair development- Week 52 | Stage V | 22 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Female- Pubic hair development- Week 104 | Stage I | 0 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Female- Pubic hair development- Week 104 | Stage II | 0 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Female- Pubic hair development- Week 104 | Stage III | 1 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Female- Pubic hair development- Week 104 | Stage IV | 2 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Female- Pubic hair development- Week 104 | Stage V | 13 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Male- Pubic hair development- Week 52 | Stage I | 1 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Male- Pubic hair development- Week 52 | Stage II | 1 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Male- Pubic hair development- Week 52 | Stage III | 2 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Male- Pubic hair development- Week 52 | Stage IV | 6 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Male- Pubic hair development- Week 52 | Stage V | 14 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Male- Pubic hair development- Week 104 | Stage I | 0 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Male- Pubic hair development- Week 104 | Stage II | 1 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Male- Pubic hair development- Week 104 | Stage III | 0 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Male- Pubic hair development- Week 104 | Stage IV | 4 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 | Male- Pubic hair development- Week 104 | Stage V | 9 Participants |
Secondary
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156
Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V, where stage I represents pre-adoloscent development and stage V represents pubertal development equivalent to that of an adult. The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of subjects at different Tanner stages at week 52 and week 156. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.
Time frame: Week 52, week 156
Population: Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-156. Number analyzed= subjects with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Female- Breast development- Week 52 | Stage I | 0 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Female- Breast development- Week 52 | Stage II | 0 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Female- Breast development- Week 52 | Stage III | 1 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Female- Breast development- Week 52 | Stage IV | 5 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Female- Breast development- Week 52 | Stage V | 21 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Female- Breast development- Week 156 | Stage I | 0 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Female- Breast development- Week 156 | Stage II | 0 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Female- Breast development- Week 156 | Stage III | 0 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Female- Breast development- Week 156 | Stage IV | 3 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Female- Breast development- Week 156 | Stage V | 11 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Male- Penis development- Week 52 | Stage I | 1 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Male- Penis development- Week 52 | Stage II | 2 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Male- Penis development- Week 52 | Stage III | 0 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Male- Penis development- Week 52 | Stage IV | 7 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Male- Penis development- Week 52 | Stage V | 14 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Male- Penis development- Week 156 | Stage I | 0 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Male- Penis development- Week 156 | Stage II | 0 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Male- Penis development- Week 156 | Stage III | 1 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Male- Penis development- Week 156 | Stage IV | 3 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Male- Penis development- Week 156 | Stage V | 9 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Female- Pubic hair development- Week 52 | Stage I | 0 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Female- Pubic hair development- Week 52 | Stage II | 0 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Female- Pubic hair development- Week 52 | Stage III | 2 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Female- Pubic hair development- Week 52 | Stage IV | 2 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Female- Pubic hair development- Week 52 | Stage V | 22 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Female- Pubic hair development- Week 156 | Stage I | 0 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Female- Pubic hair development- Week 156 | Stage II | 0 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Female- Pubic hair development- Week 156 | Stage III | 0 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Female- Pubic hair development- Week 156 | Stage IV | 2 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Female- Pubic hair development- Week 156 | Stage V | 11 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Male- Pubic hair development- Week 52 | Stage I | 1 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Male- Pubic hair development- Week 52 | Stage II | 1 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Male- Pubic hair development- Week 52 | Stage III | 2 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Male- Pubic hair development- Week 52 | Stage IV | 6 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Male- Pubic hair development- Week 52 | Stage V | 14 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Male- Pubic hair development- Week 156 | Stage I | 0 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Male- Pubic hair development- Week 156 | Stage II | 0 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Male- Pubic hair development- Week 156 | Stage III | 1 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Male- Pubic hair development- Week 156 | Stage IV | 3 Participants |
| Liraglutide 1.8 mg | Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 | Male- Pubic hair development- Week 156 | Stage V | 10 Participants |
Secondary
Growth (Height Velocity)
Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days.
Time frame: Week 0, week 26
Population: Safety analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Growth (Height Velocity) | 1.633 cm/year | Standard Deviation 2.016 |
| Placebo | Growth (Height Velocity) | 2.486 cm/year | Standard Deviation 2.834 |
Secondary
Growth (Height Velocity)
Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days.
Time frame: Week 0, week 52
Population: Safety analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Growth (Height Velocity) | 1.345 cm/year | Standard Deviation 1.73 |
| Placebo | Growth (Height Velocity) | 1.817 cm/year | Standard Deviation 2.043 |
Secondary
Growth (Height Velocity)- Week 104
Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.
Time frame: Week 0, week 104
Population: Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-104. Overall number of participants analyzed= subjects with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Growth (Height Velocity)- Week 104 | 1.149 cm/year | Standard Deviation 1.776 |
Secondary
Growth (Height Velocity)- Week 156
Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.
Time frame: Week 0, week 156
Population: Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-156. Overall number of participants analyzed= subjects with available data at week 156.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Growth (Height Velocity)- Week 156 | 1.100 cm/year | Standard Deviation 1.504 |
Secondary
Height Velocity SDS
Height velocity SDS scores at week 26. Height velocity is change in height per year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 26
Population: Safety analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Height Velocity SDS | -1.24 SDS score | Standard Deviation 1.695 |
| Placebo | Height Velocity SDS | -0.557 SDS score | Standard Deviation 2.058 |
Secondary
Height Velocity SDS
Height velocity SDS scores at week 52. Height velocity is change in height per year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 52
Population: Safety analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Height Velocity SDS | -0.887 SDS score | Standard Deviation 1.46 |
| Placebo | Height Velocity SDS | -0.551 SDS score | Standard Deviation 1.711 |
Secondary
Height Velocity SDS- Week 104
The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.
Time frame: Week 0, week 104
Population: Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-104. Overall number of participants analyzed= subjects with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Height Velocity SDS- Week 104 | -0.523 SDS score | Standard Deviation 1.466 |
Secondary
Height Velocity SDS- Week 156
The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.
Time frame: Week 0, week 156
Population: Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-156. Overall number of participants analyzed= subjects with available data at week 156.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Height Velocity SDS- Week 156 | 0.142 SDS score | Standard Deviation 1.156 |
Secondary
Number of Adverse Events (Week 0-26)
Total number of adverse events during 26 weeks.
Time frame: 0-26 weeks
Population: Safety analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liraglutide 1.8 mg | Number of Adverse Events (Week 0-26) | 310 events |
| Placebo | Number of Adverse Events (Week 0-26) | 230 events |
Secondary
Number of Adverse Events (Week 0-52)
Total number of adverse events during entire treatment period.
Time frame: 0-52 weeks
Population: Safety analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liraglutide 1.8 mg | Number of Adverse Events (Week 0-52) | 426 events |
| Placebo | Number of Adverse Events (Week 0-52) | 321 events |
Secondary
Number of Adverse Events (Week 53-104)
This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. Number of adverse events reported during follow-up 1 (week 53 to 104).
Time frame: Week 53-104
Population: Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-104.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liraglutide 1.8 mg | Number of Adverse Events (Week 53-104) | 30 events |
Secondary
Number of Adverse Events (Week 53-156)
This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. Number of adverse events reported during the follow-up period (weeks 53 to 156).
Time frame: Week 53-156
Population: Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during weeks 53-156.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liraglutide 1.8 mg | Number of Adverse Events (Week 53-156) | 47 events |
Secondary
Number of Hypoglycaemic Episodes
Total number of hypoglycaemic episodes according to American Diabetes Association (ADA) classification from baseline (week 0) to week 26.
Time frame: 0-26 weeks
Population: Safety analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liraglutide 1.8 mg | Number of Hypoglycaemic Episodes | 92 hypoglycaemic episodes |
| Placebo | Number of Hypoglycaemic Episodes | 43 hypoglycaemic episodes |
Secondary
Number of Hypoglycaemic Episodes
Total number of hypoglycaemic episodes according to American Diabetes Association (ADA) classification from baseline (week 0) to week 52.
Time frame: 0-52 weeks
Population: Safety analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liraglutide 1.8 mg | Number of Hypoglycaemic Episodes | 160 hypoglycaemic episodes |
| Placebo | Number of Hypoglycaemic Episodes | 63 hypoglycaemic episodes |
Secondary
Number of Serious Adverse Events (Week 0-26)
Total number of serious adverse events during 26 weeks.
Time frame: 0-26 weeks
Population: Safety analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liraglutide 1.8 mg | Number of Serious Adverse Events (Week 0-26) | 7 events |
| Placebo | Number of Serious Adverse Events (Week 0-26) | 4 events |
Secondary
Number of Serious Adverse Events (Week 0-52)
Total number of serious adverse events during entire treatment period.
Time frame: 0-52 weeks
Population: Safety analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liraglutide 1.8 mg | Number of Serious Adverse Events (Week 0-52) | 10 events |
| Placebo | Number of Serious Adverse Events (Week 0-52) | 5 events |
Secondary
Number of Serious Adverse Events (Week 53-104)
This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. Number of serious adverse events reported during follow up 1 (week 53 to 104).
Time frame: Weeks 53-104
Population: Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-104.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liraglutide 1.8 mg | Number of Serious Adverse Events (Week 53-104) | 7 events |
Secondary
Number of Serious Adverse Events (Week 53-156)
This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. Number of serious adverse events reported during the follow up period (week 53 to 156).
Time frame: Weeks 53-156
Population: Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during weeks 53-156.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liraglutide 1.8 mg | Number of Serious Adverse Events (Week 53-156) | 9 events |
Secondary
Number of Subjects Having HbA1c Below 7.0%
Number of subjects achieving HbA1c \<7.0% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 52
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide 1.8 mg | Number of Subjects Having HbA1c Below 7.0% | Yes | 27 Participants |
| Liraglutide 1.8 mg | Number of Subjects Having HbA1c Below 7.0% | No | 29 Participants |
| Placebo | Number of Subjects Having HbA1c Below 7.0% | Yes | 16 Participants |
| Placebo | Number of Subjects Having HbA1c Below 7.0% | No | 36 Participants |
Secondary
Number of Subjects Having HbA1c Below 7.0%
Percentage of subjects having HbA1c \<7.0%. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 26
Population: Full analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liraglutide 1.8 mg | Number of Subjects Having HbA1c Below 7.0% | 63.7 Percentage of subjects |
| Placebo | Number of Subjects Having HbA1c Below 7.0% | 36.5 Percentage of subjects |
Comparison: Missing data was imputed using pattern mixture model. For each imputed data set the binary response was analysed in a logistic regression model using a logit link with treatment and stratification group (gender\*age group) as fixed factors and baseline HbA1c as covariate.The estimated treatment effects and confidence intervals were combined using Rubin´s formula.p-value: <0.00195% CI: [2.105, 13.615]logistic regression model
Secondary
Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes
Number of subjects achieving HbA1c \<7.0% without severe or minor hypoglycaemic episodes after 52 weeks. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemia was defined as meeting either of the below criteria: 1. an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose \<2.8 mmol/L (50 mg/dL) or plasma glucose \<3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself 2. any asymptomatic blood glucose value \<2.8 mmol/L (50 mg/dL) or plasma glucose value \<3.1 mmol/L (56 mg/dL) All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 52
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide 1.8 mg | Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes | Yes | 22 Participants |
| Liraglutide 1.8 mg | Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes | No | 34 Participants |
| Placebo | Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes | Yes | 16 Participants |
| Placebo | Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes | No | 36 Participants |
Secondary
Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes
Number of subjects achieving HbA1c \<7.0% without severe or minor hypoglycaemic episodes after 26 weeks. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemia was defined as meeting either of the below criteria: 1. an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose \<2.8 mmol/L (50 mg/dL) or plasma glucose \<3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself 2. any asymptomatic blood glucose value \<2.8 mmol/L (50 mg/dL) or plasma glucose value \<3.1 mmol/L (56 mg/dL) All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 26
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide 1.8 mg | Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes | Yes | 31 Participants |
| Liraglutide 1.8 mg | Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes | No | 28 Participants |
| Placebo | Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes | Yes | 21 Participants |
| Placebo | Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes | No | 37 Participants |
Secondary
Number of Subjects Having HbA1c Below 7.5%
Number of subjects achieving HbA1c \<7.5% after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 26
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide 1.8 mg | Number of Subjects Having HbA1c Below 7.5% | Yes | 43 Participants |
| Liraglutide 1.8 mg | Number of Subjects Having HbA1c Below 7.5% | No | 16 Participants |
| Placebo | Number of Subjects Having HbA1c Below 7.5% | Yes | 29 Participants |
| Placebo | Number of Subjects Having HbA1c Below 7.5% | No | 29 Participants |
Secondary
Number of Subjects Having HbA1c Below 7.5%
Number of subjects achieving HbA1c \<7.5% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 52
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide 1.8 mg | Number of Subjects Having HbA1c Below 7.5% | Yes | 36 Participants |
| Liraglutide 1.8 mg | Number of Subjects Having HbA1c Below 7.5% | No | 20 Participants |
| Placebo | Number of Subjects Having HbA1c Below 7.5% | Yes | 23 Participants |
| Placebo | Number of Subjects Having HbA1c Below 7.5% | No | 29 Participants |
Secondary
Number of Subjects Having HbA1c Maximum 6.5%
Number of subjects achieving HbA1c \<=6.5% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 52
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide 1.8 mg | Number of Subjects Having HbA1c Maximum 6.5% | Yes | 25 Participants |
| Liraglutide 1.8 mg | Number of Subjects Having HbA1c Maximum 6.5% | No | 31 Participants |
| Placebo | Number of Subjects Having HbA1c Maximum 6.5% | Yes | 13 Participants |
| Placebo | Number of Subjects Having HbA1c Maximum 6.5% | No | 39 Participants |
Secondary
Number of Subjects Having HbA1c Maximum 6.5%
Number of subjects achieving HbA1c \<=6.5% after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 26
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide 1.8 mg | Number of Subjects Having HbA1c Maximum 6.5% | Yes | 28 Participants |
| Liraglutide 1.8 mg | Number of Subjects Having HbA1c Maximum 6.5% | No | 31 Participants |
| Placebo | Number of Subjects Having HbA1c Maximum 6.5% | Yes | 19 Participants |
| Placebo | Number of Subjects Having HbA1c Maximum 6.5% | No | 39 Participants |
Secondary
Pubertal Assessment/Progression (Tanner Staging)
Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V. The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of participants at different Tanner stages at week 0, week 26 and week 52.
Time frame: Week 0, week 26, week 52
Population: Safety analysis set. Number of participants analysed=participants with available data
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 26 | Stage III | 2 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 52 | Stage II | 0 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 26 | Stage IV | 7 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 0 | Stage II | 2 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 26 | Stage V | 13 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 52 | Stage III | 1 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 52 | Stage I | 1 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 26 | Stage II | 1 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 52 | Stage II | 2 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 52 | Stage IV | 5 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 52 | Stage III | 0 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 0 | Stage IV | 8 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 52 | Stage IV | 7 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 52 | Stage V | 27 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 52 | Stage V | 15 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 26 | Stage III | 2 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 0 | Stage I | 3 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 0 | Stage I | 2 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 0 | Stage II | 3 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 0 | Stage I | 1 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 0 | Stage III | 8 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 0 | Stage II | 1 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 0 | Stage IV | 14 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 26 | Stage IV | 5 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 0 | Stage V | 38 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 0 | Stage III | 2 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 26 | Stage I | 3 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 0 | Stage V | 26 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 26 | Stage II | 0 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 0 | Stage IV | 9 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 26 | Stage III | 5 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 26 | Stage V | 29 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 26 | Stage IV | 11 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 0 | Stage V | 11 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 26 | Stage V | 43 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 0 | Stage III | 4 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 52 | Stage I | 1 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 26 | Stage I | 2 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 52 | Stage II | 1 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 52 | Stage I | 0 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 52 | Stage III | 4 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 52 | Stage IV | 8 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 26 | Stage II | 1 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 52 | Stage V | 43 Participants |
| Liraglutide 1.8 mg | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 26 | Stage I | 0 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 52 | Stage V | 34 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 0 | Stage I | 0 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 0 | Stage II | 0 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 0 | Stage III | 10 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 0 | Stage IV | 9 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 0 | Stage V | 23 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 26 | Stage I | 0 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 26 | Stage II | 0 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 26 | Stage III | 4 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 26 | Stage IV | 10 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 26 | Stage V | 22 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 52 | Stage I | 0 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 52 | Stage II | 0 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 52 | Stage III | 2 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 52 | Stage IV | 9 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Female - Breast development - Week 52 | Stage V | 22 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 0 | Stage I | 0 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 0 | Stage II | 3 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 0 | Stage III | 6 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 0 | Stage IV | 11 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 0 | Stage V | 6 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 26 | Stage I | 0 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 26 | Stage II | 1 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 26 | Stage III | 4 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 26 | Stage IV | 8 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 26 | Stage V | 10 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 52 | Stage I | 0 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 52 | Stage II | 0 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 52 | Stage III | 2 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 52 | Stage IV | 6 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Male - Penis Development - Week 52 | Stage V | 13 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 0 | Stage I | 3 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 0 | Stage II | 0 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 0 | Stage III | 10 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 0 | Stage IV | 25 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 0 | Stage V | 29 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 26 | Stage I | 0 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 26 | Stage II | 2 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 26 | Stage III | 4 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 26 | Stage IV | 18 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 26 | Stage V | 34 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 52 | Stage I | 0 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 52 | Stage II | 0 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 52 | Stage IV | 17 Participants |
| Placebo | Pubertal Assessment/Progression (Tanner Staging) | Pubic Hair Development - Week 52 | Stage III | 2 Participants |
Secondary
Ratio to Baseline: Fasting C-peptide
Ratio to baseline (fasting C-peptide) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 52
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Ratio to Baseline: Fasting C-peptide | 0.94 ratio | Geometric Coefficient of Variation 40.8 |
| Placebo | Ratio to Baseline: Fasting C-peptide | 0.83 ratio | Geometric Coefficient of Variation 56.5 |
Secondary
Ratio to Baseline: Fasting C-peptide
Ratio to baseline (fasting C-peptide) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 26
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Ratio to Baseline: Fasting C-peptide | 0.93 ratio | Geometric Coefficient of Variation 39.7 |
| Placebo | Ratio to Baseline: Fasting C-peptide | 0.84 ratio | Geometric Coefficient of Variation 82.3 |
Secondary
Ratio to Baseline: Fasting Glucagon
Ratio to baseline (fasting glucagon) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 52
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Ratio to Baseline: Fasting Glucagon | 1.01 ratio | Geometric Coefficient of Variation 35 |
| Placebo | Ratio to Baseline: Fasting Glucagon | 1.05 ratio | Geometric Coefficient of Variation 32.7 |
Secondary
Ratio to Baseline: Fasting Glucagon
Ratio to baseline (fasting glucagon) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 26
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Ratio to Baseline: Fasting Glucagon | 0.98 ratio | Geometric Coefficient of Variation 29.3 |
| Placebo | Ratio to Baseline: Fasting Glucagon | 1.03 ratio | Geometric Coefficient of Variation 32.4 |
Secondary
Ratio to Baseline: Fasting Insulin
Ratio to baseline (fasting insulin) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 26
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Ratio to Baseline: Fasting Insulin | 0.9 ratio | Geometric Coefficient of Variation 76.4 |
| Placebo | Ratio to Baseline: Fasting Insulin | 1.0 ratio | Geometric Coefficient of Variation 77.9 |
Secondary
Ratio to Baseline: Fasting Insulin
Ratio to baseline (fasting insulin) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 52
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Ratio to Baseline: Fasting Insulin | 1.0 ratio | Geometric Coefficient of Variation 80.6 |
| Placebo | Ratio to Baseline: Fasting Insulin | 1.1 ratio | Geometric Coefficient of Variation 142.8 |
Secondary
Ratio to Baseline: Fasting Pro-insulin
Ratio to baseline (fasting pro-insulin) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 52
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Ratio to Baseline: Fasting Pro-insulin | 0.62 ratio | Geometric Coefficient of Variation 118 |
| Placebo | Ratio to Baseline: Fasting Pro-insulin | 0.79 ratio | Geometric Coefficient of Variation 121 |
Secondary
Ratio to Baseline: Fasting Pro-insulin
Ratio to baseline (fasting pro-insulin) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 26
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Ratio to Baseline: Fasting Pro-insulin | 0.62 ratio | Geometric Coefficient of Variation 110.3 |
| Placebo | Ratio to Baseline: Fasting Pro-insulin | 0.88 ratio | Geometric Coefficient of Variation 131.6 |
Secondary
Ratio to Baseline: Free Fatty Acids
Ratio to baseline (free fatty acids) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 26
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Ratio to Baseline: Free Fatty Acids | 1.023 ratio | Geometric Coefficient of Variation 67.4 |
| Placebo | Ratio to Baseline: Free Fatty Acids | 0.985 ratio | Geometric Coefficient of Variation 47.5 |
Secondary
Ratio to Baseline: Free Fatty Acids
Ratio to baseline (free fatty acids) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 52
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Ratio to Baseline: Free Fatty Acids | 0.928 ratio | Geometric Coefficient of Variation 58.2 |
| Placebo | Ratio to Baseline: Free Fatty Acids | 0.868 ratio | Geometric Coefficient of Variation 54.8 |
Secondary
Ratio to Baseline: HDL Cholesterol
Ratio to baseline (HDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 52
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Ratio to Baseline: HDL Cholesterol | 1.028 ratio | Geometric Coefficient of Variation 16 |
| Placebo | Ratio to Baseline: HDL Cholesterol | 1.000 ratio | Geometric Coefficient of Variation 18.8 |
Secondary
Ratio to Baseline: High-density Lipoprotein (HDL) Cholesterol
Ratio to baseline (HDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 26
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Ratio to Baseline: High-density Lipoprotein (HDL) Cholesterol | 0.997 ratio | Geometric Coefficient of Variation 18.7 |
| Placebo | Ratio to Baseline: High-density Lipoprotein (HDL) Cholesterol | 0.981 ratio | Geometric Coefficient of Variation 16.3 |
Secondary
Ratio to Baseline: HOMA-B
Ratio to baseline (HOMA-B) after 52 weeks. HOMA-B is an index of beta-cell function and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 52
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Ratio to Baseline: HOMA-B | 1.48 ratio | Geometric Coefficient of Variation 105 |
| Placebo | Ratio to Baseline: HOMA-B | 0.93 ratio | Geometric Coefficient of Variation 166.8 |
Secondary
Ratio to Baseline: HOMA-IR
Ratio to baseline (HOMA-IR) after 52 weeks. HOMA-IR is an index of insulin resistance and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 52
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Ratio to Baseline: HOMA-IR | 0.82 ratio | Geometric Coefficient of Variation 86.4 |
| Placebo | Ratio to Baseline: HOMA-IR | 1.08 ratio | Geometric Coefficient of Variation 140.3 |
Secondary
Ratio to Baseline: Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)
Ratio to baseline (HOMA-IR) after 26 weeks. HOMA-IR is an index of insulin resistance and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 26
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Ratio to Baseline: Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR) | 0.73 ratio | Geometric Coefficient of Variation 80.5 |
| Placebo | Ratio to Baseline: Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR) | 0.98 ratio | Geometric Coefficient of Variation 80.8 |
Secondary
Ratio to Baseline: Homeostasis Model Assessment of Beta-cell Function (HOMA-B)
Ratio to baseline (HOMA-B) after 26 weeks. HOMA-B is an index of beta-cell function and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 26
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Ratio to Baseline: Homeostasis Model Assessment of Beta-cell Function (HOMA-B) | 1.24 ratio | Geometric Coefficient of Variation 96.9 |
| Placebo | Ratio to Baseline: Homeostasis Model Assessment of Beta-cell Function (HOMA-B) | 1.01 ratio | Geometric Coefficient of Variation 119 |
Secondary
Ratio to Baseline: LDL Cholesterol
Ratio to baseline (LDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 52
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Ratio to Baseline: LDL Cholesterol | 1.042 ratio | Geometric Coefficient of Variation 46.3 |
| Placebo | Ratio to Baseline: LDL Cholesterol | 1.035 ratio | Geometric Coefficient of Variation 21.5 |
Secondary
Ratio to Baseline: Low Density Lipoprotein (LDL) Cholesterol
Ratio to baseline (LDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 26
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Ratio to Baseline: Low Density Lipoprotein (LDL) Cholesterol | 0.998 ratio | Geometric Coefficient of Variation 24.8 |
| Placebo | Ratio to Baseline: Low Density Lipoprotein (LDL) Cholesterol | 0.993 ratio | Geometric Coefficient of Variation 20.4 |
Secondary
Ratio to Baseline: Pro-insulin/Insulin Ratio
Ratio to baseline (Pro-insulin/insulin ratio) after week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 52
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Ratio to Baseline: Pro-insulin/Insulin Ratio | 0.689 ratio | Geometric Coefficient of Variation 106.6 |
| Placebo | Ratio to Baseline: Pro-insulin/Insulin Ratio | 0.770 ratio | Geometric Coefficient of Variation 225.1 |
Secondary
Ratio to Baseline: Pro-insulin/Insulin Ratio
Ratio to baseline (Pro-insulin/insulin ratio) after week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 26
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Ratio to Baseline: Pro-insulin/Insulin Ratio | 0.690 ratio | Geometric Coefficient of Variation 102.4 |
| Placebo | Ratio to Baseline: Pro-insulin/Insulin Ratio | 0.923 ratio | Geometric Coefficient of Variation 197.6 |
Secondary
Ratio to Baseline: Total Cholesterol
Ratio to baseline (total cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 52
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Ratio to Baseline: Total Cholesterol | 1.013 ratio | Geometric Coefficient of Variation 21 |
| Placebo | Ratio to Baseline: Total Cholesterol | 1.026 ratio | Geometric Coefficient of Variation 13.5 |
Secondary
Ratio to Baseline: Total Cholesterol
Ratio to baseline (total cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 26
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Ratio to Baseline: Total Cholesterol | 0.975 ratio | Geometric Coefficient of Variation 17.7 |
| Placebo | Ratio to Baseline: Total Cholesterol | 1.008 ratio | Geometric Coefficient of Variation 13.3 |
Secondary
Ratio to Baseline: Triglycerides
Ratio to baseline (triglycerides) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 26
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Ratio to Baseline: Triglycerides | 0.894 ratio | Geometric Coefficient of Variation 50.6 |
| Placebo | Ratio to Baseline: Triglycerides | 1.038 ratio | Geometric Coefficient of Variation 36 |
Secondary
Ratio to Baseline: Triglycerides
Ratio to baseline (triglycerides) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 52
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Ratio to Baseline: Triglycerides | 0.964 ratio | Geometric Coefficient of Variation 50.5 |
| Placebo | Ratio to Baseline: Triglycerides | 1.036 ratio | Geometric Coefficient of Variation 48.4 |
Secondary
Ratio to Baseline: Very Low-density Lipoprotein (VLDL) Cholesterol
Ratio to baseline (VLDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 26
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Ratio to Baseline: Very Low-density Lipoprotein (VLDL) Cholesterol | 0.890 ratio | Geometric Coefficient of Variation 51.6 |
| Placebo | Ratio to Baseline: Very Low-density Lipoprotein (VLDL) Cholesterol | 1.035 ratio | Geometric Coefficient of Variation 35.3 |
Secondary
Ratio to Baseline: VLDL Cholesterol
Ratio to baseline (VLDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Time frame: Week 0, week 52
Population: Full analysis set. Number of participants analysed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 1.8 mg | Ratio to Baseline: VLDL Cholesterol | 0.983 ratio | Geometric Coefficient of Variation 48.4 |
| Placebo | Ratio to Baseline: VLDL Cholesterol | 1.003 ratio | Geometric Coefficient of Variation 45.5 |