Metabolism and Nutrition Disorder, Obesity
Conditions
Brief summary
This trial is conducted globally. The aim of this trial is to investigate effect and safety of liraglutide 3.0 mg in subjects with overweight or obesity and type 2 diabetes mellitus treated with basal insulin.
Interventions
Injected subcutaneously (s.c., under the skin) once daily
DRUGPlacebo
Injected subcutaneously (s.c., under the skin) once daily
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Diagnosed with type 2 diabetes mellitus - Treatment with up to 2 OADs (oral anti-diabetic) (metformin, glitazone, SGLT-2 inhibitor (sodium-glucose cotransporter-2 inhibitors) or sulphonylurea) - Stable treatment with basal insulin according to its label (no requirement of minimum or maximum dose) for at least 90 days prior to screening, as judged by the investigator - HbA1c (glycosylated haemoglobin) 6.0-10.0% (both inclusive) - BMI (body mass index) equal to or above 27 kg/m\^2 - Age at least 18 years at the time of signing informed consent
Exclusion criteria
- Diagnosis of type 1 diabetes - Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8 (see Section 8.2.3) - Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator - Unable or unwilling to perform self-monitoring of plasma glucose according to the protocol and to keep a diabetes diary - Treatment with any hypoglycaemic medications other than OADs and basal insulin within the past 90 days prior to screening - Treatment with a DPP-IV (dipeptidyl peptidase-4) inhibitor within the past 90 days prior to screening - Recent history of cardiovascular disease (myocardial infarction or stroke within the past 6 months), severe congestive heart failure (NYHA class III, IV), or second degree or greater heart block - Personal or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasia type 2 (MEN2) - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice) - For Germany: Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner - Use in past 90 days of medications known to induce significant weight loss (e.g., prescription weight loss medications) or weight gain (e.g., chronic use of oral steroids, second generation antipsychotics) - History of pancreatitis (acute or chronic) - History of major depressive disorder within the past 2 years - Any lifetime history of a suicide attempt - Inadequately treated blood pressure defined as Grade 3 hypertension or higher (Systolic above or equal to 180 mmHg or diastolic above or equal to110 mmHg). - History of malignancy (except for non-melanoma skin cancer) within the past 5 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight (%) | Week 0, week 56 | Change in body weight from baseline (week 0) to week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for adverse events \[AEs\]) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs). |
| Participants Losing at Least 5% of Baseline Body Weight | Week 56 | The estimated percentage of participants losing at least 5% of baseline (week 0) body weight at week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for adverse events \[AEs\]) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | Week 0, week 56 | Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs). |
| Change in FPG | Week 0, week 56 | Change in fasting plasma glucose (FPG) from baseline (week 0) to week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs). |
| Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score | Week 0, week 56 | SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline (week 0) in SF-36 physical functioning score was presented based on in-trial data and on-drug data. A positive change score indicates an improvement since baseline. |
| Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT), Physical Function Domain (5-items) Score | Week 0, week 56 | Change in IWQoL-Lite for CT physical function domain (5-items) score. IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. The endpoint was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs). |
| Change in Total Daily Insulin Dose (U) | Week 0, week 56 | Change in total daily insulin dose from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Change in Total Daily Basal Insulin Dose (% of Pre-trial Dose in U) | Week 0, week 56 | Change in total daily basal insulin dose from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Change in Total Daily Basal Insulin Dose (U/kg) | Week 0, week 56 | Change in total daily basal insulin dose from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Change in Total Daily Insulin Dose (U/kg) | Week 0, week 56 | Change in total daily insulin dose from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Change in 7-point SMPG Profile Mean Daytime Glucose Value | Week 0, week 56 | Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner and at bedtime. Change from baseline (week 0) to week 56 in 7-point self-measured plasma glucose (SMPG) profile mean daytime glucose value was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Change in sBP and dBP | Week 0, week 56 | Change in systolic blood pressure (sBP) and diastolic blood pressure (dBP) from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Change in Lipids -Total Cholesterol, HDL, LDL, VLDL, Triglycerides and FFA | Week 0, week 56 | Change in total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, very low density lipoprotein (VLDL) cholesterol, triglycerides and free fatty acids (FFA) from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Change in SF-36: Sub-domains | Week 0, week 56 | SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in the sub-domain scores was presented based on in-trial data. A positive change score indicates an improvement since baseline. Results are presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Change in SF-36: Physical Component Summary (PCS) | Week 0, week 56 | Change in short form 36 v2.0 acute domain physical component summary (PCS) from baseline (week 0) to week 56 was presented based on in-trial data. SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. It consists of 2 component summary measures that further summarize 8 health domain scales. The physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. |
| Change in SF-36: Mental Component Summary (MCS) | Week 0, week 56 | Change in short form 36 v2.0 acute domain mental component summary (MCS) from baseline (week 0) to week 56 was presented based on in-trial data. SF- 36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. |
| Change in IWQoL-Lite for CT: Pain/Discomfort Domain Score | Week 0, week 56 | Change in IWQoL-Lite for CT pain and discomfort domain from baseline (week 0) to week 56 was presented based on in-trial data. IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Change in IWQoL-Lite for CT: Psychosocial Domain Score | Week 0, week 56 | Change in IWQoL-Lite for CT psychosocial domain from baseline (week 0) to week 56 was presented based on in-trial data. IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Change in IWQoL-Lite for CT: Total Score | Week 0, week 56 | Change in IWQoL-Lite for CT total score from baseline (week 0) to week 56 was presented based on in-trial data. IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0, week 56 | The WRSS measure is a questionnaire under development. The version applied in this study has 10 items that measure the presence and bothersomeness of 10 weight-related symptoms. Each item has a categorical part with answers on the following 5 possible levels: 'Never/Almost never', 'Rarely', 'Sometimes', 'Often' and 'Almost always/Always'. Number of participants in each category at baseline (week 0) and week 56 was presented. Scoring algorithm was not available prior to database lock and therefore it was decided and documented in the statistical analysis plan that WRSS total score was not to be calculated and analyzed. |
| Participants Who Achieved (Yes/no): HbA1c <7% and Weight Loss ≥5% | Week 56 | Percentage of participants who achieved HbA1c \<7% and weight loss ≥5% from baseline at week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Participants Who Achieved (Yes/no): HbA1c <7%, Weight Loss ≥5% and no Documented Symptomatic Hypoglycaemia | Week 56 | Percentage of participants who achieved HbA1c \<7%, weight loss ≥5% from baseline and no documented symptomatic hypoglycaemia at week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Participants Who Achieved (Yes/no): ≥4.3 T-score Points Increase From Baseline in SF-36 Acute Physical Functioning Score | Week 56 | Percentage of participants who achieved ≥4.3 T-score points increase from baseline in SF-36 acute physical functioning score at week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Participants Who Achieved (Yes/no): ≥3.8 T-score Points Increase From Baseline in SF-36 Acute PCS | Week 56 | Percentage of participants who achieved ≥3.8 T-score points increase from baseline in SF-36 acute PCS at week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Participants Who Achieved (Yes/no): ≥4.6 T-score Points Increase From Baseline in SF-36 Acute MCS | Week 56 | Percentage of participants who achieved ≥4.6 T-score points increase from baseline in SF-36 acute MCS at week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Responder Definition Value for IWQoL-Lite for CT Physical Function Domain Score | Week 56 | Percentage of participants who achieve responder definition value for IWQoL-Lite for CT physical function domain score was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Adverse Events (AEs) | Week 0 to week 56 + 30 days | An AE was defined as any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily have a causal relationship with this treatment. Number of AEs from randomisation to until the end of the post-treatment follow-up period (30 days). Results based on in-trial data was presented. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Number of Hypoglycaemic Episodes | Week 0 to week 56 + 30 days | Number of hypoglycaemic episodes was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Change in Physical Examination | Week -1, week 56 | Physical examination parameters are categorised as abdomen; gastrointestinal system; cardiovascular system; central and peripheral nervous system; general appearance; head, eyes, ears, nose, throat (ENT) and neck; lymph node palpation; musculoskeletal system; respiratory system; skin and thyroid gland. The number of participants assessed as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) at baseline (week -1) and week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Change in Resting Pulse | Week -1, week 56 | Change from baseline (week -1) to week 56 in resting pulse was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Change in Electrocardiogram (ECG) | Week -1, week 56 | The ECGs were interpreted by the investigator at baseline (week -1) and week 56 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 56 were presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Change in Laboratory Measurements (Haematology) - Haemoglobin | Week 0, week 56 | Change from baseline (week 0) to week 56 in haemoglobin was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Change in Laboratory Measurements (Haematology) - Haematocrit | Week 0, week 56 | Change from baseline (week 0) to week 56 in Haematocrit was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Change in Laboratory Measurements (Haematology) - Erythrocytes | Week 0, week 56 | Change from baseline (week 0) to week 56 in erythrocytes was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Change in Laboratory Measurements (Haematology) - Thrombocytes, Leukocytes | Week 0, week 56 | Change from baseline (week 0) to week 56 in thrombocytes and leukocytes was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Change in Laboratory Parameters (Biochemistry) - Albumin | Week 0, week 56 | Change from baseline (week 0) to week 56 in albumin was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Change in Laboratory Parameters (Biochemistry) - Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase | Week 0, week 56 | Change from baseline (week 0) to week 56 in alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase and lipase was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Change in Laboratory Parameters (Biochemistry) - Bicarbonate, Total Calcium, Potassium, Sodium and Urea | Week 0, week 56 | Change from baseline (week 0) to week 56 in bicarbonate, total calcium, potassium, sodium and urea was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Change in Laboratory Parameters (Biochemistry) - Total Bilirubin and Creatinine | Week 0, week 56 | Change from baseline (week 0) to week 56 in total bilirubin and creatinine was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Change in Laboratory Parameters (Biochemistry) - High Sensitive C-reactive Protein | Week 0, week 56 | Change from baseline (week 0) to week 56 in high sensitive C-reactive protein was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Participants Losing More Than 10% of Baseline Body Weight at Week 56 | Week 56 | The estimated percentage of participants losing more than 10% of baseline (week 0) body weight at week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for adverse events \[AEs\]) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs). |
| Change in Laboratory Parameters (Biochemistry) - Uric Acid | Week 0, week 56 | Change from baseline (week 0) to week 56 in uric acid was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Change in Laboratory Parameters (Biochemistry) - Calcitonin | Week 0, week 56 | Change from baseline (week 0) to week 56 in calcitonin was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Change in Laboratory Parameters (Biochemistry) - Thyroid Stimulating Hormone | Week 0, week 56 | Change from baseline (week 0) to week 56 in thyroid stimulating hormone was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Change in Laboratory Parameters (Biochemistry) - eGFR | Week 0, week 56 | Change from baseline (week 0) to week 56 in estimated GFR serum using Modification of Diet in Renal Disease (MDRD) formula was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Change in Waist Circumference | Week 0, week 56 | Change in waist circumference from baseline (week 0) to week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs). |
Countries
Canada, Germany, Israel, Italy, Mexico, Turkey (Türkiye), United States
Participant flow
Recruitment details
The trial was conducted at 53 sites in Canada (7), Germany (7), Israel (6), Italy (4), Mexico (2), Turkey (7) and United States (20).
Pre-assignment details
Participants were randomised in a 1:1 manner to receive either liraglutide or placebo as an adjunct to a reduced-calorie diet and increased physical activity as part of a comprehensive lifestyle intervention program.
Participants by arm
| Arm | Count |
|---|---|
| Liraglutide 3.0 mg Participants received liraglutide once daily by subcutaneous injection irrespective of the timing of meals. Participants received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the maintenance dose of 3.0 mg was reached after 4 weeks. The treatment period was 56 weeks. | 198 |
| Placebo Participants received matching placebo once daily by subcutaneous injection irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. The treatment period was 56 weeks. | 198 |
| Total | 396 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 15 | 6 |
| Overall Study | Lack of Efficacy | 1 | 1 |
| Overall Study | Lost to Follow-up | 2 | 3 |
| Overall Study | Other | 8 | 14 |
| Overall Study | Protocol deviation | 6 | 6 |
Baseline characteristics
| Characteristic | Liraglutide 3.0 mg | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 55.9 years STANDARD_DEVIATION 11.3 | 57.6 years STANDARD_DEVIATION 10.4 | 56.8 years STANDARD_DEVIATION 10.9 |
| Body weight | 100.6 Kilograms (kg) STANDARD_DEVIATION 20.8 | 98.9 Kilograms (kg) STANDARD_DEVIATION 19.9 | 99.7 Kilograms (kg) STANDARD_DEVIATION 20.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 43 Participants | 29 Participants | 72 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 155 Participants | 169 Participants | 324 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 5 Participants | 8 Participants |
| Race/Ethnicity, Customized Black or African American | 17 Participants | 11 Participants | 28 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 174 Participants | 180 Participants | 354 Participants |
| Sex: Female, Male Female | 108 Participants | 99 Participants | 207 Participants |
| Sex: Female, Male Male | 90 Participants | 99 Participants | 189 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 195 | 0 / 197 |
| other Total, other adverse events | 162 / 195 | 141 / 197 |
| serious Total, serious adverse events | 16 / 195 | 19 / 197 |
Outcome results
Primary
Change in Body Weight (%)
Change in body weight from baseline (week 0) to week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for adverse events \[AEs\]) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).
Time frame: Week 0, week 56
Population: Full analysis set included all randomised participants. Number analyzed=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Body Weight (%) | In-trial observation period | -6.0 Percentage change | Standard Deviation 6 |
| Liraglutide 3.0 mg | Change in Body Weight (%) | On-drug observation period | -6.5 Percentage change | Standard Deviation 5.8 |
| Placebo | Change in Body Weight (%) | In-trial observation period | -1.5 Percentage change | Standard Deviation 5.4 |
| Placebo | Change in Body Weight (%) | On-drug observation period | -1.7 Percentage change | Standard Deviation 5.2 |
Comparison: Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, body mass index (BMI) groups and sex as factors and baseline body weight as covariate.p-value: <0.000195% CI: [-5.48, -3.16]ANCOVA
Comparison: Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups and sex as factors and baseline body weight as covariate, all nested within visit.p-value: <0.000195% CI: [-6.3, -3.91]MMRM
Primary
Participants Losing at Least 5% of Baseline Body Weight
The estimated percentage of participants losing at least 5% of baseline (week 0) body weight at week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for adverse events \[AEs\]) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).
Time frame: Week 56
Population: Full analysis set included all randomised participants. Number analyzed=participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Liraglutide 3.0 mg | Participants Losing at Least 5% of Baseline Body Weight | In-trial observation period | 51.80 Percentage of participants |
| Liraglutide 3.0 mg | Participants Losing at Least 5% of Baseline Body Weight | On-drug observation period | 56.92 Percentage of participants |
| Placebo | Participants Losing at Least 5% of Baseline Body Weight | In-trial observation period | 23.98 Percentage of participants |
| Placebo | Participants Losing at Least 5% of Baseline Body Weight | On-drug observation period | 21.83 Percentage of participants |
Comparison: Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using a logistic regression model with treatment, BMI groups and sex as factors and baseline body weight as covariate.p-value: <0.000195% CI: [2.19, 5.31]Regression, Logistic
Comparison: Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups and sex as factors and baseline body weight as covariate, all nested within visit. The MMRM was used to classify responders and analysed with a logistic regression with treatment as the only factor.p-value: <0.000195% CI: [3.04, 7.36]Mixed model for repeated measurements
Secondary
Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily have a causal relationship with this treatment. Number of AEs from randomisation to until the end of the post-treatment follow-up period (30 days). Results based on in-trial data was presented. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 0 to week 56 + 30 days
Population: Safety analysis set (SAS) included all randomised participants exposed to at least one dose of trial drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liraglutide 3.0 mg | Adverse Events (AEs) | 1223 Adverse events |
| Placebo | Adverse Events (AEs) | 1148 Adverse events |
Secondary
Change in 7-point SMPG Profile Mean Daytime Glucose Value
Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner and at bedtime. Change from baseline (week 0) to week 56 in 7-point self-measured plasma glucose (SMPG) profile mean daytime glucose value was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 0, week 56
Population: Full analysis set included all randomised participants. Number analyzed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 3.0 mg | Change in 7-point SMPG Profile Mean Daytime Glucose Value | -2.2 mmol/L | Standard Deviation 2.6 |
| Placebo | Change in 7-point SMPG Profile Mean Daytime Glucose Value | -1.6 mmol/L | Standard Deviation 2.8 |
Secondary
Change in Electrocardiogram (ECG)
The ECGs were interpreted by the investigator at baseline (week -1) and week 56 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 56 were presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week -1, week 56
Population: SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide 3.0 mg | Change in Electrocardiogram (ECG) | Normal (week -1) | 113 Participants |
| Liraglutide 3.0 mg | Change in Electrocardiogram (ECG) | Abnormal NCS (week -1) | 78 Participants |
| Liraglutide 3.0 mg | Change in Electrocardiogram (ECG) | Abnormal CS (week -1) | 4 Participants |
| Liraglutide 3.0 mg | Change in Electrocardiogram (ECG) | Normal (week 56) | 118 Participants |
| Liraglutide 3.0 mg | Change in Electrocardiogram (ECG) | Abnormal NCS (week 56) | 62 Participants |
| Liraglutide 3.0 mg | Change in Electrocardiogram (ECG) | Abnormal CS (week 56) | 5 Participants |
| Placebo | Change in Electrocardiogram (ECG) | Abnormal NCS (week 56) | 57 Participants |
| Placebo | Change in Electrocardiogram (ECG) | Normal (week -1) | 133 Participants |
| Placebo | Change in Electrocardiogram (ECG) | Normal (week 56) | 126 Participants |
| Placebo | Change in Electrocardiogram (ECG) | Abnormal NCS (week -1) | 60 Participants |
| Placebo | Change in Electrocardiogram (ECG) | Abnormal CS (week 56) | 3 Participants |
| Placebo | Change in Electrocardiogram (ECG) | Abnormal CS (week -1) | 4 Participants |
Secondary
Change in FPG
Change in fasting plasma glucose (FPG) from baseline (week 0) to week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).
Time frame: Week 0, week 56
Population: Full analysis set included all randomised participants. Number analyzed=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in FPG | In-trial observation period | -0.91 Millimoles per liter (mmol/L) | Standard Deviation 3.13 |
| Liraglutide 3.0 mg | Change in FPG | On-drug observation period | -1.05 Millimoles per liter (mmol/L) | Standard Deviation 3.08 |
| Placebo | Change in FPG | In-trial observation period | -0.68 Millimoles per liter (mmol/L) | Standard Deviation 3.04 |
| Placebo | Change in FPG | On-drug observation period | -0.96 Millimoles per liter (mmol/L) | Standard Deviation 2.68 |
Secondary
Change in HbA1c
Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).
Time frame: Week 0, week 56
Population: Full analysis set included all randomised participants. Number analyzed=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in HbA1c | In-trial observation period | -1.1 Percentage of HbA1c | Standard Deviation 1.2 |
| Liraglutide 3.0 mg | Change in HbA1c | On-drug observation period | -1.2 Percentage of HbA1c | Standard Deviation 1.1 |
| Placebo | Change in HbA1c | In-trial observation period | -0.5 Percentage of HbA1c | Standard Deviation 1.2 |
| Placebo | Change in HbA1c | On-drug observation period | -0.7 Percentage of HbA1c | Standard Deviation 1 |
Secondary
Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT), Physical Function Domain (5-items) Score
Change in IWQoL-Lite for CT physical function domain (5-items) score. IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. The endpoint was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).
Time frame: Week 0, week 56
Population: Full analysis set included all randomised participants. Number analyzed=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT), Physical Function Domain (5-items) Score | In-trial observation period | 7.3 Score on a scale | Standard Deviation 22.5 |
| Liraglutide 3.0 mg | Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT), Physical Function Domain (5-items) Score | On-drug observation period | 8.2 Score on a scale | Standard Deviation 20.9 |
| Placebo | Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT), Physical Function Domain (5-items) Score | In-trial observation period | 6.8 Score on a scale | Standard Deviation 21.5 |
| Placebo | Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT), Physical Function Domain (5-items) Score | On-drug observation period | 6.5 Score on a scale | Standard Deviation 21.8 |
Secondary
Change in IWQoL-Lite for CT: Pain/Discomfort Domain Score
Change in IWQoL-Lite for CT pain and discomfort domain from baseline (week 0) to week 56 was presented based on in-trial data. IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 0, week 56
Population: Full analysis set included all randomised participants. Number analyzed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 3.0 mg | Change in IWQoL-Lite for CT: Pain/Discomfort Domain Score | 4.0 Score on a scale | Standard Deviation 22.1 |
| Placebo | Change in IWQoL-Lite for CT: Pain/Discomfort Domain Score | 4.6 Score on a scale | Standard Deviation 23.1 |
Secondary
Change in IWQoL-Lite for CT: Psychosocial Domain Score
Change in IWQoL-Lite for CT psychosocial domain from baseline (week 0) to week 56 was presented based on in-trial data. IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 0, week 56
Population: Full analysis set included all randomised participants. Number analyzed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 3.0 mg | Change in IWQoL-Lite for CT: Psychosocial Domain Score | 5.4 Score on a scale | Standard Deviation 18.4 |
| Placebo | Change in IWQoL-Lite for CT: Psychosocial Domain Score | 4.0 Score on a scale | Standard Deviation 16.7 |
Secondary
Change in IWQoL-Lite for CT: Total Score
Change in IWQoL-Lite for CT total score from baseline (week 0) to week 56 was presented based on in-trial data. IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 0, week 56
Population: Full analysis set included all randomised participants. Number analyzed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 3.0 mg | Change in IWQoL-Lite for CT: Total Score | 5.7 Score on a scale | Standard Deviation 17.6 |
| Placebo | Change in IWQoL-Lite for CT: Total Score | 4.8 Score on a scale | Standard Deviation 16.6 |
Secondary
Change in Laboratory Measurements (Haematology) - Erythrocytes
Change from baseline (week 0) to week 56 in erythrocytes was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 0, week 56
Population: SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 3.0 mg | Change in Laboratory Measurements (Haematology) - Erythrocytes | -0.07 10^12 cells per liter (10^12 cells/L) | Standard Deviation 0.27 |
| Placebo | Change in Laboratory Measurements (Haematology) - Erythrocytes | -0.04 10^12 cells per liter (10^12 cells/L) | Standard Deviation 0.28 |
Secondary
Change in Laboratory Measurements (Haematology) - Haematocrit
Change from baseline (week 0) to week 56 in Haematocrit was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 0, week 56
Population: SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 3.0 mg | Change in Laboratory Measurements (Haematology) - Haematocrit | -0.4 Percentage of red blood cells | Standard Deviation 2.8 |
| Placebo | Change in Laboratory Measurements (Haematology) - Haematocrit | -0.2 Percentage of red blood cells | Standard Deviation 3 |
Secondary
Change in Laboratory Measurements (Haematology) - Haemoglobin
Change from baseline (week 0) to week 56 in haemoglobin was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 0, week 56
Population: SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 3.0 mg | Change in Laboratory Measurements (Haematology) - Haemoglobin | -0.1 mmol/L | Standard Deviation 0.5 |
| Placebo | Change in Laboratory Measurements (Haematology) - Haemoglobin | -0.1 mmol/L | Standard Deviation 0.6 |
Secondary
Change in Laboratory Measurements (Haematology) - Thrombocytes, Leukocytes
Change from baseline (week 0) to week 56 in thrombocytes and leukocytes was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 0, week 56
Population: SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Laboratory Measurements (Haematology) - Thrombocytes, Leukocytes | Thrombocytes | 7 10^9 cells/L | Standard Deviation 45 |
| Liraglutide 3.0 mg | Change in Laboratory Measurements (Haematology) - Thrombocytes, Leukocytes | Leukocytes | -0.22 10^9 cells/L | Standard Deviation 1.41 |
| Placebo | Change in Laboratory Measurements (Haematology) - Thrombocytes, Leukocytes | Thrombocytes | 7 10^9 cells/L | Standard Deviation 46 |
| Placebo | Change in Laboratory Measurements (Haematology) - Thrombocytes, Leukocytes | Leukocytes | -0.24 10^9 cells/L | Standard Deviation 1.28 |
Secondary
Change in Laboratory Parameters (Biochemistry) - Albumin
Change from baseline (week 0) to week 56 in albumin was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 0, week 56
Population: SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 3.0 mg | Change in Laboratory Parameters (Biochemistry) - Albumin | -0.1 Grams per deciliter (g/dL) | Standard Deviation 0.2 |
| Placebo | Change in Laboratory Parameters (Biochemistry) - Albumin | -0.1 Grams per deciliter (g/dL) | Standard Deviation 0.2 |
Secondary
Change in Laboratory Parameters (Biochemistry) - Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase
Change from baseline (week 0) to week 56 in alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase and lipase was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 0, week 56
Population: SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Laboratory Parameters (Biochemistry) - Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase | Aspartate aminotransferase | -3 Units per liter (U/L) | Standard Deviation 11 |
| Liraglutide 3.0 mg | Change in Laboratory Parameters (Biochemistry) - Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase | Alkaline Phosphatase | -1 Units per liter (U/L) | Standard Deviation 16 |
| Liraglutide 3.0 mg | Change in Laboratory Parameters (Biochemistry) - Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase | Alanine Aminotransferase | -5 Units per liter (U/L) | Standard Deviation 15 |
| Liraglutide 3.0 mg | Change in Laboratory Parameters (Biochemistry) - Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase | Amylase | 13 Units per liter (U/L) | Standard Deviation 73 |
| Liraglutide 3.0 mg | Change in Laboratory Parameters (Biochemistry) - Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase | Lipase | 30 Units per liter (U/L) | Standard Deviation 143 |
| Placebo | Change in Laboratory Parameters (Biochemistry) - Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase | Lipase | -8 Units per liter (U/L) | Standard Deviation 47 |
| Placebo | Change in Laboratory Parameters (Biochemistry) - Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase | Amylase | -1 Units per liter (U/L) | Standard Deviation 22 |
| Placebo | Change in Laboratory Parameters (Biochemistry) - Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase | Alkaline Phosphatase | -0 Units per liter (U/L) | Standard Deviation 15 |
| Placebo | Change in Laboratory Parameters (Biochemistry) - Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase | Aspartate aminotransferase | -3 Units per liter (U/L) | Standard Deviation 14 |
| Placebo | Change in Laboratory Parameters (Biochemistry) - Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase | Alanine Aminotransferase | -6 Units per liter (U/L) | Standard Deviation 18 |
Secondary
Change in Laboratory Parameters (Biochemistry) - Bicarbonate, Total Calcium, Potassium, Sodium and Urea
Change from baseline (week 0) to week 56 in bicarbonate, total calcium, potassium, sodium and urea was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 0, week 56
Population: SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Laboratory Parameters (Biochemistry) - Bicarbonate, Total Calcium, Potassium, Sodium and Urea | Total Calcium | -0.00 mmol/L | Standard Deviation 0.11 |
| Liraglutide 3.0 mg | Change in Laboratory Parameters (Biochemistry) - Bicarbonate, Total Calcium, Potassium, Sodium and Urea | Sodium | -1 mmol/L | Standard Deviation 2 |
| Liraglutide 3.0 mg | Change in Laboratory Parameters (Biochemistry) - Bicarbonate, Total Calcium, Potassium, Sodium and Urea | Potassium | -0.0 mmol/L | Standard Deviation 0.5 |
| Liraglutide 3.0 mg | Change in Laboratory Parameters (Biochemistry) - Bicarbonate, Total Calcium, Potassium, Sodium and Urea | Urea | 0.1 mmol/L | Standard Deviation 1.5 |
| Liraglutide 3.0 mg | Change in Laboratory Parameters (Biochemistry) - Bicarbonate, Total Calcium, Potassium, Sodium and Urea | Bicarbonate serum | 0 mmol/L | Standard Deviation 2 |
| Placebo | Change in Laboratory Parameters (Biochemistry) - Bicarbonate, Total Calcium, Potassium, Sodium and Urea | Urea | 0.1 mmol/L | Standard Deviation 1.4 |
| Placebo | Change in Laboratory Parameters (Biochemistry) - Bicarbonate, Total Calcium, Potassium, Sodium and Urea | Bicarbonate serum | -0 mmol/L | Standard Deviation 2 |
| Placebo | Change in Laboratory Parameters (Biochemistry) - Bicarbonate, Total Calcium, Potassium, Sodium and Urea | Total Calcium | -0.02 mmol/L | Standard Deviation 0.14 |
| Placebo | Change in Laboratory Parameters (Biochemistry) - Bicarbonate, Total Calcium, Potassium, Sodium and Urea | Potassium | -0.0 mmol/L | Standard Deviation 0.5 |
| Placebo | Change in Laboratory Parameters (Biochemistry) - Bicarbonate, Total Calcium, Potassium, Sodium and Urea | Sodium | -0 mmol/L | Standard Deviation 3 |
Secondary
Change in Laboratory Parameters (Biochemistry) - Calcitonin
Change from baseline (week 0) to week 56 in calcitonin was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 0, week 56
Population: SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 3.0 mg | Change in Laboratory Parameters (Biochemistry) - Calcitonin | 0.0 Nanograms per liter (ng/L) | Standard Deviation 1.5 |
| Placebo | Change in Laboratory Parameters (Biochemistry) - Calcitonin | 0.0 Nanograms per liter (ng/L) | Standard Deviation 1.4 |
Secondary
Change in Laboratory Parameters (Biochemistry) - eGFR
Change from baseline (week 0) to week 56 in estimated GFR serum using Modification of Diet in Renal Disease (MDRD) formula was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 0, week 56
Population: SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 3.0 mg | Change in Laboratory Parameters (Biochemistry) - eGFR | 0 Milliliters per minute per 1.73m^2 | Standard Deviation 13 |
| Placebo | Change in Laboratory Parameters (Biochemistry) - eGFR | 1 Milliliters per minute per 1.73m^2 | Standard Deviation 13 |
Secondary
Change in Laboratory Parameters (Biochemistry) - High Sensitive C-reactive Protein
Change from baseline (week 0) to week 56 in high sensitive C-reactive protein was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 0, week 56
Population: SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 3.0 mg | Change in Laboratory Parameters (Biochemistry) - High Sensitive C-reactive Protein | -1.40 Milligrams per liter (mg/L) | Standard Deviation 8.02 |
| Placebo | Change in Laboratory Parameters (Biochemistry) - High Sensitive C-reactive Protein | -1.29 Milligrams per liter (mg/L) | Standard Deviation 10.07 |
Secondary
Change in Laboratory Parameters (Biochemistry) - Thyroid Stimulating Hormone
Change from baseline (week 0) to week 56 in thyroid stimulating hormone was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 0, week 56
Population: SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 3.0 mg | Change in Laboratory Parameters (Biochemistry) - Thyroid Stimulating Hormone | -0.0842 Milli-international units per liter | Standard Deviation 1.2233 |
| Placebo | Change in Laboratory Parameters (Biochemistry) - Thyroid Stimulating Hormone | 0.1002 Milli-international units per liter | Standard Deviation 0.9493 |
Secondary
Change in Laboratory Parameters (Biochemistry) - Total Bilirubin and Creatinine
Change from baseline (week 0) to week 56 in total bilirubin and creatinine was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 0, week 56
Population: SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Laboratory Parameters (Biochemistry) - Total Bilirubin and Creatinine | Total Bilirubin | 1.0 Micromoles per liter (umol/L) | Standard Deviation 3.9 |
| Liraglutide 3.0 mg | Change in Laboratory Parameters (Biochemistry) - Total Bilirubin and Creatinine | Creatinine | -0.1 Micromoles per liter (umol/L) | Standard Deviation 8.7 |
| Placebo | Change in Laboratory Parameters (Biochemistry) - Total Bilirubin and Creatinine | Total Bilirubin | 0.6 Micromoles per liter (umol/L) | Standard Deviation 3.6 |
| Placebo | Change in Laboratory Parameters (Biochemistry) - Total Bilirubin and Creatinine | Creatinine | -0.2 Micromoles per liter (umol/L) | Standard Deviation 8.4 |
Secondary
Change in Laboratory Parameters (Biochemistry) - Uric Acid
Change from baseline (week 0) to week 56 in uric acid was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 0, week 56
Population: SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 3.0 mg | Change in Laboratory Parameters (Biochemistry) - Uric Acid | -0.2 mg/dL | Standard Deviation 1 |
| Placebo | Change in Laboratory Parameters (Biochemistry) - Uric Acid | -0.0 mg/dL | Standard Deviation 0.9 |
Secondary
Change in Lipids -Total Cholesterol, HDL, LDL, VLDL, Triglycerides and FFA
Change in total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, very low density lipoprotein (VLDL) cholesterol, triglycerides and free fatty acids (FFA) from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 0, week 56
Population: Full analysis set included all randomised participants. Number analyzed=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Lipids -Total Cholesterol, HDL, LDL, VLDL, Triglycerides and FFA | VLDL cholesterol | -0.09 mmol/L | Standard Deviation 0.35 |
| Liraglutide 3.0 mg | Change in Lipids -Total Cholesterol, HDL, LDL, VLDL, Triglycerides and FFA | HDL cholesterol | 0.05 mmol/L | Standard Deviation 0.17 |
| Liraglutide 3.0 mg | Change in Lipids -Total Cholesterol, HDL, LDL, VLDL, Triglycerides and FFA | Triglycerides | -0.21 mmol/L | Standard Deviation 0.89 |
| Liraglutide 3.0 mg | Change in Lipids -Total Cholesterol, HDL, LDL, VLDL, Triglycerides and FFA | Total cholesterol | -0.12 mmol/L | Standard Deviation 0.82 |
| Liraglutide 3.0 mg | Change in Lipids -Total Cholesterol, HDL, LDL, VLDL, Triglycerides and FFA | Free fatty acids | -0.10 mmol/L | Standard Deviation 0.27 |
| Liraglutide 3.0 mg | Change in Lipids -Total Cholesterol, HDL, LDL, VLDL, Triglycerides and FFA | LDL cholesterol | -0.08 mmol/L | Standard Deviation 0.72 |
| Placebo | Change in Lipids -Total Cholesterol, HDL, LDL, VLDL, Triglycerides and FFA | Free fatty acids | -0.06 mmol/L | Standard Deviation 0.34 |
| Placebo | Change in Lipids -Total Cholesterol, HDL, LDL, VLDL, Triglycerides and FFA | Total cholesterol | 0.04 mmol/L | Standard Deviation 0.69 |
| Placebo | Change in Lipids -Total Cholesterol, HDL, LDL, VLDL, Triglycerides and FFA | HDL cholesterol | 0.03 mmol/L | Standard Deviation 0.17 |
| Placebo | Change in Lipids -Total Cholesterol, HDL, LDL, VLDL, Triglycerides and FFA | VLDL cholesterol | -0.04 mmol/L | Standard Deviation 0.33 |
| Placebo | Change in Lipids -Total Cholesterol, HDL, LDL, VLDL, Triglycerides and FFA | Triglycerides | -0.08 mmol/L | Standard Deviation 0.8 |
| Placebo | Change in Lipids -Total Cholesterol, HDL, LDL, VLDL, Triglycerides and FFA | LDL cholesterol | 0.05 mmol/L | Standard Deviation 0.57 |
Secondary
Change in Physical Examination
Physical examination parameters are categorised as abdomen; gastrointestinal system; cardiovascular system; central and peripheral nervous system; general appearance; head, eyes, ears, nose, throat (ENT) and neck; lymph node palpation; musculoskeletal system; respiratory system; skin and thyroid gland. The number of participants assessed as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) at baseline (week -1) and week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week -1, week 56
Population: SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide 3.0 mg | Change in Physical Examination | Musculoskeletal System (week 56) Abnormal NCS | 13 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Abdomen (week 56) Abnormal, CS | 3 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | General Appearance (week -1) Normal | 150 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Gastrointestinal System (week -1) Abnormal NCS | 10 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Musculoskeletal System (week 56) Abnormal CS | 1 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Gastrointestinal System (week -1) Abnormal CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Head, eyes, ENTand Neck (week -1) Normal | 176 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Gastrointestinal System (week 56) Normal | 175 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Respiratory System (week -1) Normal | 192 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Gastrointestinal System (week 56) Abnormal NCS | 10 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Cardiovascular System (week 56) Abnormal NCS | 6 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Gastrointestinal System (week 56) Abnormal CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Lymph Node Palpation (week -1) Abnormal NCS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Respiratory System (week -1) Abnormal NCS | 3 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Cardiovascular System (week-1) Normal | 183 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Cardiovascular System (week-1) Abnormal CS | 2 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Respiratory System (week -1) Abnormal CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Cardiovascular System (week 56) Abnormal CS | 1 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Lymph Node Palpation (week -1) Abnormal CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Nervous System (week -1) Normal | 158 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Respiratory System (week 56) Normal | 183 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Nervous System (week -1) Abnormal NCS | 26 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Nervous System (week -1) Abnormal CS | 11 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Respiratory System (week 56) Abnormal CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Nervous System (week 56) Abnormal NCS | 22 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Lymph Node Palpation (week 56) Normal | 185 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Nervous System (week 56) Abnormal CS | 13 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Skin (week -1) Normal | 155 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | General Appearance (week -1) Abnormal NCS | 39 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Lymph Node Palpation (week 56) Abnormal NCS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | General Appearance (week -1) Abnormal CS | 6 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Skin (week -1) Abnormal NCS | 36 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | General Appearance (week 56) Normal | 156 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Lymph Node Palpation (week 56) Abnormal CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | General Appearance (week 56) Abnormal NCS | 23 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Skin (week -1) Abnormal CS | 4 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | General Appearance (week 56) Abnormal CS | 6 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Cardiovascular System (week-1) Abnormal NCS | 10 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Skin (week 56) Normal | 150 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Head, eyes, ENTand Neck (week -1) Abnormal NCS | 17 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Musculoskeletal System (week -1) Normal | 180 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Head, eyes, ENTand Neck (week -1) Abnormal CS | 2 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Skin (week 56) Abnormal NCS | 28 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Head, eyes, ENTand Neck (week 56) Normal | 168 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Head, eyes, ENTand Neck (week 56) Abnormal NCS | 15 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Cardiovascular System (week 56) Normal | 178 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Head, eyes, ENTand Neck (week 56) Abnormal CS | 2 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Lymph Node Palpation (week -1) Normal | 195 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Skin (week 56) Abnormal CS | 7 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Musculoskeletal System (week -1) Abnormal CS | 2 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Nervous System (week 56) Normal | 150 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Musculoskeletal System (week -1) Abnormal NCS | 13 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Abdomen (week -1) Abnormal, NCS | 25 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Respiratory System (week 56) Abnormal NCS | 2 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Thyroid Gland (week -1) Normal | 183 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Abdomen (week -1) Abnormal CS | 5 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Thyroid Gland (week -1) Abnormal NCS | 10 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Musculoskeletal System (week 56) Normal | 171 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Thyroid Gland (week -1) Abnormal CS | 2 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Abdomen (week 56) Normal | 167 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Thyroid Gland (week 56) Normal | 180 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Gastrointestinal System (week -1) Normal | 185 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Thyroid Gland (week 56) Abnormal NCS | 5 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Abdomen (week 56) Abnormal, NCS | 15 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Thyroid Gland (week 56) Abnormal CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Abdomen (week -1) Normal | 165 Participants |
| Placebo | Change in Physical Examination | Thyroid Gland (week 56) Abnormal CS | 3 Participants |
| Placebo | Change in Physical Examination | Abdomen (week -1) Abnormal, NCS | 25 Participants |
| Placebo | Change in Physical Examination | Abdomen (week 56) Abnormal, CS | 3 Participants |
| Placebo | Change in Physical Examination | Cardiovascular System (week 56) Normal | 175 Participants |
| Placebo | Change in Physical Examination | Cardiovascular System (week 56) Abnormal NCS | 12 Participants |
| Placebo | Change in Physical Examination | Head, eyes, ENTand Neck (week 56) Normal | 173 Participants |
| Placebo | Change in Physical Examination | Nervous System (week -1) Abnormal CS | 13 Participants |
| Placebo | Change in Physical Examination | Nervous System (week 56) Abnormal CS | 14 Participants |
| Placebo | Change in Physical Examination | Head, eyes, ENTand Neck (week 56) Abnormal CS | 2 Participants |
| Placebo | Change in Physical Examination | Lymph Node Palpation (week -1) Abnormal NCS | 0 Participants |
| Placebo | Change in Physical Examination | Lymph Node Palpation (week -1) Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | Lymph Node Palpation (week 56) Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | Musculoskeletal System (week -1) Normal | 180 Participants |
| Placebo | Change in Physical Examination | Musculoskeletal System (week -1) Abnormal CS | 1 Participants |
| Placebo | Change in Physical Examination | Musculoskeletal System (week 56) Normal | 171 Participants |
| Placebo | Change in Physical Examination | Musculoskeletal System (week 56) Abnormal NCS | 14 Participants |
| Placebo | Change in Physical Examination | Musculoskeletal System (week 56) Abnormal CS | 2 Participants |
| Placebo | Change in Physical Examination | Respiratory System (week -1) Normal | 192 Participants |
| Placebo | Change in Physical Examination | Respiratory System (week 56) Normal | 185 Participants |
| Placebo | Change in Physical Examination | Respiratory System (week -1) Abnormal NCS | 3 Participants |
| Placebo | Change in Physical Examination | Respiratory System (week -1) Abnormal CS | 2 Participants |
| Placebo | Change in Physical Examination | Respiratory System (week 56) Abnormal NCS | 0 Participants |
| Placebo | Change in Physical Examination | Respiratory System (week 56) Abnormal CS | 2 Participants |
| Placebo | Change in Physical Examination | Skin (week -1) Normal | 156 Participants |
| Placebo | Change in Physical Examination | Skin (week -1) Abnormal NCS | 33 Participants |
| Placebo | Change in Physical Examination | Skin (week -1) Abnormal CS | 8 Participants |
| Placebo | Change in Physical Examination | Skin (week 56) Normal | 149 Participants |
| Placebo | Change in Physical Examination | Skin (week 56) Abnormal NCS | 29 Participants |
| Placebo | Change in Physical Examination | Skin (week 56) Abnormal CS | 9 Participants |
| Placebo | Change in Physical Examination | Abdomen (week -1) Normal | 169 Participants |
| Placebo | Change in Physical Examination | Abdomen (week -1) Abnormal CS | 3 Participants |
| Placebo | Change in Physical Examination | Abdomen (week 56) Normal | 160 Participants |
| Placebo | Change in Physical Examination | Abdomen (week 56) Abnormal, NCS | 24 Participants |
| Placebo | Change in Physical Examination | Gastrointestinal System (week -1) Normal | 187 Participants |
| Placebo | Change in Physical Examination | Gastrointestinal System (week -1) Abnormal NCS | 10 Participants |
| Placebo | Change in Physical Examination | Gastrointestinal System (week -1) Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | Gastrointestinal System (week 56) Normal | 177 Participants |
| Placebo | Change in Physical Examination | Gastrointestinal System (week 56) Abnormal NCS | 8 Participants |
| Placebo | Change in Physical Examination | Gastrointestinal System (week 56) Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | Cardiovascular System (week-1) Normal | 182 Participants |
| Placebo | Change in Physical Examination | Cardiovascular System (week-1) Abnormal NCS | 15 Participants |
| Placebo | Change in Physical Examination | Cardiovascular System (week-1) Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | Cardiovascular System (week 56) Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | Nervous System (week -1) Normal | 159 Participants |
| Placebo | Change in Physical Examination | Nervous System (week -1) Abnormal NCS | 25 Participants |
| Placebo | Change in Physical Examination | Nervous System (week 56) Normal | 149 Participants |
| Placebo | Change in Physical Examination | Nervous System (week 56) Abnormal NCS | 24 Participants |
| Placebo | Change in Physical Examination | General Appearance (week -1) Normal | 150 Participants |
| Placebo | Change in Physical Examination | General Appearance (week -1) Abnormal NCS | 36 Participants |
| Placebo | Change in Physical Examination | General Appearance (week -1) Abnormal CS | 11 Participants |
| Placebo | Change in Physical Examination | General Appearance (week 56) Normal | 151 Participants |
| Placebo | Change in Physical Examination | General Appearance (week 56) Abnormal NCS | 27 Participants |
| Placebo | Change in Physical Examination | General Appearance (week 56) Abnormal CS | 9 Participants |
| Placebo | Change in Physical Examination | Head, eyes, ENTand Neck (week -1) Normal | 182 Participants |
| Placebo | Change in Physical Examination | Head, eyes, ENTand Neck (week -1) Abnormal NCS | 13 Participants |
| Placebo | Change in Physical Examination | Head, eyes, ENTand Neck (week -1) Abnormal CS | 2 Participants |
| Placebo | Change in Physical Examination | Head, eyes, ENTand Neck (week 56) Abnormal NCS | 12 Participants |
| Placebo | Change in Physical Examination | Lymph Node Palpation (week -1) Normal | 197 Participants |
| Placebo | Change in Physical Examination | Lymph Node Palpation (week 56) Normal | 186 Participants |
| Placebo | Change in Physical Examination | Lymph Node Palpation (week 56) Abnormal NCS | 0 Participants |
| Placebo | Change in Physical Examination | Musculoskeletal System (week -1) Abnormal NCS | 16 Participants |
| Placebo | Change in Physical Examination | Thyroid Gland (week -1) Normal | 187 Participants |
| Placebo | Change in Physical Examination | Thyroid Gland (week -1) Abnormal NCS | 7 Participants |
| Placebo | Change in Physical Examination | Thyroid Gland (week -1) Abnormal CS | 3 Participants |
| Placebo | Change in Physical Examination | Thyroid Gland (week 56) Normal | 178 Participants |
| Placebo | Change in Physical Examination | Thyroid Gland (week 56) Abnormal NCS | 6 Participants |
Secondary
Change in Resting Pulse
Change from baseline (week -1) to week 56 in resting pulse was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week -1, week 56
Population: SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 3.0 mg | Change in Resting Pulse | 2 Beats/minute | Standard Deviation 9 |
| Placebo | Change in Resting Pulse | -0 Beats/minute | Standard Deviation 9 |
Secondary
Change in sBP and dBP
Change in systolic blood pressure (sBP) and diastolic blood pressure (dBP) from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 0, week 56
Population: Full analysis set included all randomised participants. Number analyzed=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in sBP and dBP | sBP | -6 Millimeters of mercury (mmHg) | Standard Deviation 14 |
| Liraglutide 3.0 mg | Change in sBP and dBP | dBP | -3 Millimeters of mercury (mmHg) | Standard Deviation 9 |
| Placebo | Change in sBP and dBP | sBP | -2 Millimeters of mercury (mmHg) | Standard Deviation 15 |
| Placebo | Change in sBP and dBP | dBP | -1 Millimeters of mercury (mmHg) | Standard Deviation 9 |
Secondary
Change in SF-36: Mental Component Summary (MCS)
Change in short form 36 v2.0 acute domain mental component summary (MCS) from baseline (week 0) to week 56 was presented based on in-trial data. SF- 36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline.
Time frame: Week 0, week 56
Population: Full analysis set included all randomised participants. Number analyzed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 3.0 mg | Change in SF-36: Mental Component Summary (MCS) | -1.9 Score on a scale | Standard Deviation 7.9 |
| Placebo | Change in SF-36: Mental Component Summary (MCS) | -1.7 Score on a scale | Standard Deviation 6.8 |
Secondary
Change in SF-36: Physical Component Summary (PCS)
Change in short form 36 v2.0 acute domain physical component summary (PCS) from baseline (week 0) to week 56 was presented based on in-trial data. SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. It consists of 2 component summary measures that further summarize 8 health domain scales. The physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline.
Time frame: Week 0, week 56
Population: Full analysis set included all randomised participants. Number analyzed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 3.0 mg | Change in SF-36: Physical Component Summary (PCS) | 2.7 Score on a scale | Standard Deviation 7.5 |
| Placebo | Change in SF-36: Physical Component Summary (PCS) | 2.2 Score on a scale | Standard Deviation 7.2 |
Secondary
Change in SF-36: Sub-domains
SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in the sub-domain scores was presented based on in-trial data. A positive change score indicates an improvement since baseline. Results are presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 0, week 56
Population: Full analysis set included all randomised participants. Number analyzed=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in SF-36: Sub-domains | Bodily Pain | 1.2 Score on a scale | Standard Deviation 8.3 |
| Liraglutide 3.0 mg | Change in SF-36: Sub-domains | Role-physical | 0.8 Score on a scale | Standard Deviation 7.7 |
| Liraglutide 3.0 mg | Change in SF-36: Sub-domains | Mental Health | -1.1 Score on a scale | Standard Deviation 8.6 |
| Liraglutide 3.0 mg | Change in SF-36: Sub-domains | Role Lim Emotion Prob | -1.2 Score on a scale | Standard Deviation 8.1 |
| Liraglutide 3.0 mg | Change in SF-36: Sub-domains | General Health | 1.9 Score on a scale | Standard Deviation 7.8 |
| Liraglutide 3.0 mg | Change in SF-36: Sub-domains | Social Functioning | -0.7 Score on a scale | Standard Deviation 7.7 |
| Liraglutide 3.0 mg | Change in SF-36: Sub-domains | Vitality | 1.0 Score on a scale | Standard Deviation 8 |
| Liraglutide 3.0 mg | Change in SF-36: Sub-domains | Physical Functioning | 2.5 Score on a scale | Standard Deviation 7.9 |
| Placebo | Change in SF-36: Sub-domains | Vitality | -0.0 Score on a scale | Standard Deviation 7.7 |
| Placebo | Change in SF-36: Sub-domains | Bodily Pain | 1.2 Score on a scale | Standard Deviation 9.1 |
| Placebo | Change in SF-36: Sub-domains | General Health | 0.3 Score on a scale | Standard Deviation 7.7 |
| Placebo | Change in SF-36: Sub-domains | Physical Functioning | 2.6 Score on a scale | Standard Deviation 7.3 |
| Placebo | Change in SF-36: Sub-domains | Role-physical | 0.9 Score on a scale | Standard Deviation 8 |
| Placebo | Change in SF-36: Sub-domains | Mental Health | -1.1 Score on a scale | Standard Deviation 7.5 |
| Placebo | Change in SF-36: Sub-domains | Social Functioning | -0.6 Score on a scale | Standard Deviation 6.3 |
| Placebo | Change in SF-36: Sub-domains | Role Lim Emotion Prob | -0.3 Score on a scale | Standard Deviation 8.2 |
Secondary
Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score
SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline (week 0) in SF-36 physical functioning score was presented based on in-trial data and on-drug data. A positive change score indicates an improvement since baseline.
Time frame: Week 0, week 56
Population: Full analysis set included all randomised participants. Number analyzed=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score | In-trial observation period | 2.5 Score on a scale | Standard Deviation 7.9 |
| Liraglutide 3.0 mg | Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score | On-drug observation period | 2.9 Score on a scale | Standard Deviation 7.8 |
| Placebo | Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score | In-trial observation period | 2.6 Score on a scale | Standard Deviation 7.3 |
| Placebo | Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score | On-drug observation period | 2.5 Score on a scale | Standard Deviation 7.1 |
Secondary
Change in Total Daily Basal Insulin Dose (% of Pre-trial Dose in U)
Change in total daily basal insulin dose from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 0, week 56
Population: Full analysis set included all randomised participants. Number analyzed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 3.0 mg | Change in Total Daily Basal Insulin Dose (% of Pre-trial Dose in U) | 19 Percentage change | Standard Deviation 121 |
| Placebo | Change in Total Daily Basal Insulin Dose (% of Pre-trial Dose in U) | 64 Percentage change | Standard Deviation 139 |
Secondary
Change in Total Daily Basal Insulin Dose (U/kg)
Change in total daily basal insulin dose from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 0, week 56
Population: Full analysis set included all randomised participants. Number analyzed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 3.0 mg | Change in Total Daily Basal Insulin Dose (U/kg) | 0.05 Units of insulin dose per kilogram(U/kg) | Standard Deviation 0.33 |
| Placebo | Change in Total Daily Basal Insulin Dose (U/kg) | 0.15 Units of insulin dose per kilogram(U/kg) | Standard Deviation 0.3 |
Secondary
Change in Total Daily Insulin Dose (U)
Change in total daily insulin dose from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 0, week 56
Population: Full analysis set included all randomised participants. Number analyzed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 3.0 mg | Change in Total Daily Insulin Dose (U) | 3 Units of insulin dose (U) | Standard Deviation 30 |
| Placebo | Change in Total Daily Insulin Dose (U) | 18 Units of insulin dose (U) | Standard Deviation 38 |
Secondary
Change in Total Daily Insulin Dose (U/kg)
Change in total daily insulin dose from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 0, week 56
Population: Full analysis set included all randomised participants. Number analyzed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 3.0 mg | Change in Total Daily Insulin Dose (U/kg) | 0.05 U/kg | Standard Deviation 0.33 |
| Placebo | Change in Total Daily Insulin Dose (U/kg) | 0.18 U/kg | Standard Deviation 0.37 |
Secondary
Change in Waist Circumference
Change in waist circumference from baseline (week 0) to week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).
Time frame: Week 0, week 56
Population: Full analysis set included all randomised participants. Number analyzed=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Waist Circumference | In-trial observation period | -5.40 Centimeters (cm) | Standard Deviation 6.06 |
| Liraglutide 3.0 mg | Change in Waist Circumference | On-drug observation period | -5.71 Centimeters (cm) | Standard Deviation 6.05 |
| Placebo | Change in Waist Circumference | In-trial observation period | -2.60 Centimeters (cm) | Standard Deviation 5.72 |
| Placebo | Change in Waist Circumference | On-drug observation period | -2.78 Centimeters (cm) | Standard Deviation 5.63 |
Secondary
Number of Hypoglycaemic Episodes
Number of hypoglycaemic episodes was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 0 to week 56 + 30 days
Population: SAS included all randomised participants exposed to at least one dose of trial drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liraglutide 3.0 mg | Number of Hypoglycaemic Episodes | 1538 Hypoglycaemic episodes |
| Placebo | Number of Hypoglycaemic Episodes | 1973 Hypoglycaemic episodes |
Secondary
Participants Losing More Than 10% of Baseline Body Weight at Week 56
The estimated percentage of participants losing more than 10% of baseline (week 0) body weight at week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for adverse events \[AEs\]) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).
Time frame: Week 56
Population: Full analysis set included all randomised participants. Number analyzed=participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Liraglutide 3.0 mg | Participants Losing More Than 10% of Baseline Body Weight at Week 56 | In-trial observation period | 22.77 Percentage of participants |
| Liraglutide 3.0 mg | Participants Losing More Than 10% of Baseline Body Weight at Week 56 | On-drug observation period | 22.56 Percentage of participants |
| Placebo | Participants Losing More Than 10% of Baseline Body Weight at Week 56 | In-trial observation period | 6.55 Percentage of participants |
| Placebo | Participants Losing More Than 10% of Baseline Body Weight at Week 56 | On-drug observation period | 5.58 Percentage of participants |
Secondary
Participants Who Achieved (Yes/no): ≥3.8 T-score Points Increase From Baseline in SF-36 Acute PCS
Percentage of participants who achieved ≥3.8 T-score points increase from baseline in SF-36 acute PCS at week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 56
Population: Full analysis set included all randomised participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liraglutide 3.0 mg | Participants Who Achieved (Yes/no): ≥3.8 T-score Points Increase From Baseline in SF-36 Acute PCS | 37.9 Percentage of participants |
| Placebo | Participants Who Achieved (Yes/no): ≥3.8 T-score Points Increase From Baseline in SF-36 Acute PCS | 31.3 Percentage of participants |
Secondary
Participants Who Achieved (Yes/no): ≥4.3 T-score Points Increase From Baseline in SF-36 Acute Physical Functioning Score
Percentage of participants who achieved ≥4.3 T-score points increase from baseline in SF-36 acute physical functioning score at week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 56
Population: Full analysis set included all randomised participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liraglutide 3.0 mg | Participants Who Achieved (Yes/no): ≥4.3 T-score Points Increase From Baseline in SF-36 Acute Physical Functioning Score | 28.8 Percentage of participants |
| Placebo | Participants Who Achieved (Yes/no): ≥4.3 T-score Points Increase From Baseline in SF-36 Acute Physical Functioning Score | 26.3 Percentage of participants |
Secondary
Participants Who Achieved (Yes/no): ≥4.6 T-score Points Increase From Baseline in SF-36 Acute MCS
Percentage of participants who achieved ≥4.6 T-score points increase from baseline in SF-36 acute MCS at week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 56
Population: Full analysis set included all randomised participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liraglutide 3.0 mg | Participants Who Achieved (Yes/no): ≥4.6 T-score Points Increase From Baseline in SF-36 Acute MCS | 14.6 Percentage of participants |
| Placebo | Participants Who Achieved (Yes/no): ≥4.6 T-score Points Increase From Baseline in SF-36 Acute MCS | 11.6 Percentage of participants |
Secondary
Participants Who Achieved (Yes/no): HbA1c <7% and Weight Loss ≥5%
Percentage of participants who achieved HbA1c \<7% and weight loss ≥5% from baseline at week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 56
Population: Full analysis set included all randomised participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liraglutide 3.0 mg | Participants Who Achieved (Yes/no): HbA1c <7% and Weight Loss ≥5% | 39.9 Percentage of participants |
| Placebo | Participants Who Achieved (Yes/no): HbA1c <7% and Weight Loss ≥5% | 13.6 Percentage of participants |
Secondary
Participants Who Achieved (Yes/no): HbA1c <7%, Weight Loss ≥5% and no Documented Symptomatic Hypoglycaemia
Percentage of participants who achieved HbA1c \<7%, weight loss ≥5% from baseline and no documented symptomatic hypoglycaemia at week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 56
Population: Full analysis set included all randomised participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liraglutide 3.0 mg | Participants Who Achieved (Yes/no): HbA1c <7%, Weight Loss ≥5% and no Documented Symptomatic Hypoglycaemia | 10.1 Percentage of participants |
| Placebo | Participants Who Achieved (Yes/no): HbA1c <7%, Weight Loss ≥5% and no Documented Symptomatic Hypoglycaemia | 3.5 Percentage of participants |
Secondary
Responder Definition Value for IWQoL-Lite for CT Physical Function Domain Score
Percentage of participants who achieve responder definition value for IWQoL-Lite for CT physical function domain score was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.
Time frame: Week 56
Population: Full analysis set included all randomised participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liraglutide 3.0 mg | Responder Definition Value for IWQoL-Lite for CT Physical Function Domain Score | 25.3 Percentage of participants |
| Placebo | Responder Definition Value for IWQoL-Lite for CT Physical Function Domain Score | 24.2 Percentage of participants |
Secondary
Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses
The WRSS measure is a questionnaire under development. The version applied in this study has 10 items that measure the presence and bothersomeness of 10 weight-related symptoms. Each item has a categorical part with answers on the following 5 possible levels: 'Never/Almost never', 'Rarely', 'Sometimes', 'Often' and 'Almost always/Always'. Number of participants in each category at baseline (week 0) and week 56 was presented. Scoring algorithm was not available prior to database lock and therefore it was decided and documented in the statistical analysis plan that WRSS total score was not to be calculated and analyzed.
Time frame: Week 0, week 56
Population: Full analysis set included all randomised participants. Number analyzed=participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Sexual desire | Often | 13 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Joint pain | Rarely | 47 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Sexual desire | Rarely | 35 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Trouble sleeping | Almost always/Always | 6 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Sexual desire | Sometimes | 23 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Joint pain | Sometimes | 49 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Sexual desire | Almost always/Always | 6 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Trouble sleeping | Never/Almost never | 119 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Sexual desire | Never/Almost never | 105 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Joint pain | Almost always/Always | 6 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Sexual desire | Often | 18 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Shortness of breath | Often | 3 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Sexual desire | Rarely | 34 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Joint pain | Never/Almost never | 95 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Sexual desire | Sometimes | 24 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Sexual desire | Never/Almost never | 119 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Heavy sweating | Never/Almost never | 101 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Joint pain | Often | 12 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Heavy sweating | Often | 15 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Trouble sleeping | Sometimes | 32 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Heavy sweating | Sometimes | 40 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Joint pain | Rarely | 35 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Heavy sweating | Almost always/Always | 1 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Trouble sleeping | Never/Almost never | 104 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Heavy sweating | Never/Almost never | 98 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Joint pain | Sometimes | 39 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Heavy sweating | Rarely | 51 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Heavy sweating | Sometimes | 30 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Low physical stamina | Almost always/Always | 2 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Low physical stamina | Rarely | 56 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Shortness of breath | Almost always/Always | 0 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Low physical stamina | Sometimes | 45 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Shortness of breath | Never/Almost never | 131 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Low physical stamina | Almost always/Always | 3 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Shortness of breath | Rarely | 28 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Low physical stamina | Never/Almost never | 77 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Low physical stamina | Often | 15 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Back pain | Rarely | 47 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Shortness of breath | Sometimes | 19 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Shortness of breath | Almost always/Always | 1 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Low physical stamina | Sometimes | 35 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Low physical stamina | Never/Almost never | 73 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Foot pain | Almost always/Always | 5 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Shortness of breath | Never/Almost never | 137 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Heavy sweating | Almost always/Always | 2 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Foot pain | Often | 17 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Shortness of breath | Often | 5 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Foot pain | Rarely | 34 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Low energy | Often | 19 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Foot pain | Sometimes | 28 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Low physical stamina | Often | 22 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Foot pain | Almost always/Always | 2 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Foot pain | Never/Almost never | 106 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Shortness of breath | Sometimes | 16 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Heat sensitivity | Almost always/Always | 8 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Foot pain | Rarely | 29 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Heavy sweating | Rarely | 40 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Foot pain | Sometimes | 35 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Heat sensitivity | Never/Almost never | 106 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Trouble sleeping | Often | 11 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Trouble sleeping | Rarely | 30 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Low energy | Often | 16 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Heat sensitivity | Sometimes | 37 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Trouble sleeping | Almost always/Always | 6 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Heat sensitivity | Often | 13 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Trouble sleeping | Often | 15 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Heat sensitivity | Rarely | 34 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Trouble sleeping | Rarely | 38 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Shortness of breath | Rarely | 45 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Trouble sleeping | Sometimes | 24 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Low energy | Rarely | 49 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Back pain | Almost always/Always | 8 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Heat sensitivity | Almost always/Always | 2 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Back pain | Never/Almost never | 96 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Low physical stamina | Rarely | 57 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Back pain | Often | 13 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Back pain | Rarely | 49 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Heat sensitivity | Never/Almost never | 92 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Back pain | Sometimes | 32 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Joint pain | Almost always/Always | 11 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Back pain | Almost always/Always | 5 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Heat sensitivity | Often | 12 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Back pain | Never/Almost never | 93 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Foot pain | Never/Almost never | 114 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Back pain | Often | 13 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Heat sensitivity | Rarely | 42 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Back pain | Sometimes | 29 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Joint pain | Never/Almost never | 74 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Low energy | Almost always/Always | 0 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Heat sensitivity | Sometimes | 39 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Low energy | Never/Almost never | 102 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Low energy | Rarely | 46 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Foot pain | Often | 15 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Low energy | Sometimes | 31 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Sexual desire | Almost always/Always | 8 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Low energy | Almost always/Always | 0 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Joint pain | Often | 17 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Low energy | Never/Almost never | 82 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Low energy | Sometimes | 40 Participants |
| Liraglutide 3.0 mg | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Heavy sweating | Often | 7 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Low energy | Sometimes | 41 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Shortness of breath | Often | 3 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Shortness of breath | Sometimes | 21 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Shortness of breath | Sometimes | 27 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Heat sensitivity | Often | 16 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Sexual desire | Sometimes | 25 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Heavy sweating | Rarely | 38 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Heavy sweating | Often | 16 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Heavy sweating | Rarely | 48 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Low physical stamina | Almost always/Always | 8 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Low physical stamina | Never/Almost never | 78 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Low physical stamina | Often | 14 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Low physical stamina | Never/Almost never | 65 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Foot pain | Sometimes | 40 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Trouble sleeping | Never/Almost never | 111 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Trouble sleeping | Often | 10 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Trouble sleeping | Never/Almost never | 98 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Back pain | Often | 8 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Back pain | Rarely | 45 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Low energy | Never/Almost never | 90 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Low energy | Often | 12 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Low energy | Never/Almost never | 77 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Low energy | Often | 16 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Low energy | Rarely | 50 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Joint pain | Almost always/Always | 5 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Joint pain | Never/Almost never | 85 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Joint pain | Often | 18 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Joint pain | Rarely | 42 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Joint pain | Sometimes | 46 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Joint pain | Almost always/Always | 5 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Joint pain | Never/Almost never | 75 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Joint pain | Often | 17 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Joint pain | Rarely | 39 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Joint pain | Sometimes | 52 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Shortness of breath | Never/Almost never | 140 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Shortness of breath | Rarely | 32 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Shortness of breath | Almost always/Always | 1 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Shortness of breath | Never/Almost never | 111 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Shortness of breath | Often | 3 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Shortness of breath | Rarely | 46 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Heat sensitivity | Almost always/Always | 9 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Heat sensitivity | Never/Almost never | 109 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Heat sensitivity | Rarely | 31 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Heat sensitivity | Sometimes | 31 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Heat sensitivity | Almost always/Always | 8 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Heat sensitivity | Never/Almost never | 87 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Heat sensitivity | Often | 13 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Heat sensitivity | Rarely | 47 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Heat sensitivity | Sometimes | 33 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Sexual desire | Almost always/Always | 8 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Sexual desire | Never/Almost never | 121 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Sexual desire | Often | 13 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Sexual desire | Rarely | 32 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Sexual desire | Sometimes | 22 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Sexual desire | Almost always/Always | 11 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Sexual desire | Never/Almost never | 109 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Sexual desire | Often | 11 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Sexual desire | Rarely | 32 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Heavy sweating | Almost always/Always | 5 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Heavy sweating | Never/Almost never | 104 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Heavy sweating | Often | 14 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Heavy sweating | Sometimes | 35 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Heavy sweating | Almost always/Always | 5 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Heavy sweating | Never/Almost never | 92 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Heavy sweating | Sometimes | 27 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Low physical stamina | Rarely | 47 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Low physical stamina | Sometimes | 49 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Low physical stamina | Almost always/Always | 4 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Low physical stamina | Often | 19 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Foot pain | Almost always/Always | 7 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Low physical stamina | Rarely | 56 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Low physical stamina | Sometimes | 44 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Foot pain | Almost always/Always | 7 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Foot pain | Never/Almost never | 108 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Foot pain | Often | 12 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Foot pain | Rarely | 31 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Foot pain | Sometimes | 38 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Foot pain | Never/Almost never | 88 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Foot pain | Often | 14 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Foot pain | Rarely | 39 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Trouble sleeping | Almost always/Always | 4 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Trouble sleeping | Rarely | 42 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Trouble sleeping | Sometimes | 29 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Trouble sleeping | Almost always/Always | 3 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Trouble sleeping | Often | 14 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Trouble sleeping | Rarely | 33 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Trouble sleeping | Sometimes | 40 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Back pain | Almost always/Always | 6 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Back pain | Never/Almost never | 98 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Back pain | Rarely | 40 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Back pain | Sometimes | 44 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Back pain | Almost always/Always | 4 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Back pain | Never/Almost never | 86 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Back pain | Often | 11 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Back pain | Sometimes | 42 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Low energy | Almost always/Always | 2 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Low energy | Rarely | 42 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Low energy | Sometimes | 50 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 56: Low energy | Almost always/Always | 4 Participants |
| Placebo | Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses | Week 0: Shortness of breath | Almost always/Always | 0 Participants |