| Primary | Change in Body Weight (%) | Observed mean change in body weight from baseline (week 0) to week 56 was evaluated for two different observation periods. 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 subjects 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). The test of superiority of liraglutide to placebo for the treatment policy estimand was tested in a hierarchical manner for the two primary and the consequent 7 confirmatory secondary endpoints presented. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | percent change | | Week 0, week 56 | | | | ID | Title | Description |
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| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
| | | Title | Denominators | Categories |
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| In-trial observation period | - ParticipantsOG000141
- ParticipantsOG001130
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Treatrment policy estimand. The hypothesis and the alternative are: H: μliraglutide ≥ μplacebo against the alternative HA: μliraglutide < μplacebo. μliraglutide and μplacebo denote the true mean of % weight change for liraglutide 3.0 mg and placebo group, respectively. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline body weight as covariate. | ANCOVA | Missing observations were imputed from the placebo arm based on a jump to reference (x100) multiple imputation approach. | 0.0003 | | Treatment difference | -3.45 | | | 2-Sided | 95 | -5.31 | -1.59 | | | Liraglutide 3.0 mg - placebo | |
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| Primary | Proportion of Subjects Losing at Least 5% of Baseline Body Weight at Week 56 | The estimated mean percentage of subjects losing at least 5% of baseline body weight at week 56 is presented. The endpoint was evaluated based on in-trial data and on-drug data. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Number | | percentage of participants | | Week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Proportion of Subjects Losing More Than 10% of Baseline Body Weight at Week 56 | The estimated mean percentage of subjects losing more than 10% of baseline body weight at week 56 is presented. The endpoint was evaluated based on in-trial data and on-drug data. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Number | | percentage of participants | | Week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Proportion of Subjects Losing More Than 15% of Baseline Body Weight at Week 56 | The estimated mean percentage of subjects losing more than 15% of baseline body weight at week 56 is presented. The endpoint was evaluated based on in-trial data and on-drug data. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Number | | percentage of participants | | Week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Proportion of Subjects Losing 4% or More of Baseline Body Weight | The estimated mean percentage of subjects losing 4% or more of baseline body weight at week 16 is presented. The endpoint was evaluated for treatment policy estimand (in-trial data). | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Number | | percentage of participants | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Change in Waist Circumference (cm) | Observed mean change from baseline in waist circumference. The endpoint was evaluated based on in-trial data and on-drug data. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | cm | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
| |
| 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 subject'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 SF-36 physical functioning score is presented. A positive change score indicates an improvement since baseline. The endpoint was evaluated based on in-trial data and on-drug data. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | Scores on a scale | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | |
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| Secondary | Change in IWQoL-Lite for CT, Physical Function Domain (5-items) Score | Observed mean change in Impact of Weight on Quality of Life-Lite for Clinical Trials Version (IWQoL-Lite for CT ) score. IWQoL-Lite for CT (Weight on Quality of Life-Lite for Clinical Trial Version) 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. The endpoint was evaluated based on in-trial data and on-drug data. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | Scores on a scale | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Change in Six Minutes Walking Distance Test (6MWT) | Observed mean change from baseline in 6 minutes walking distance test. The 6MWT is a common test of functional exercise capacity that assesses the distance a subject can walk in 6 minutes. The endpoint was evaluated based on in-trial data and on-drug data. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | meter | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Change From Baseline in HbA1c (%) | Observed mean change from baseline to week 56 in glycosylated haemoglobin (HbA1c). Results based on FAS in-trial data is presented. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | percentage | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Change From Baseline in FPG (mg/dL) | Observed mean change from baseline (week 0) in fasting plasma glucose (FPG). Results based on FAS in-trial data is presented. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | mg/dL | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Change From Baseline sBP (mmHg) | Observed mean change in systolic blood pressure from baseline to week 56. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | mmHg | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Change From Baseline dBP (mmHg) | Observed mean change from baseline (week 0) to week 56 in diastolic blood pressure (dBP). Results based on FAS in-trial data is presented. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | mmHg | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Change From Baseline in Lipids -Total Cholesterol | Observed mean change from baseline (week 0) to week 56 in total cholesterol (TC). Results based on FAS in-trial data is presented. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Change From Baseline in Lipids - LDL Cholesterol | Observed mean change from baseline in low density cholesterol (LDL) from baseline (week 0) to week 56. Results based on FAS in-trial data is presented. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Change From Baseline in Lipids - HDL Cholesterol | Observed mean change from baseline in high density (HDL) cholesterol from baseline (week 0) to week 56. Results based on FAS in-trial data is presented. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Change From Baseline in Lipids - VLDL Cholesterol | Observed mean change from baseline in very low density cholesterol (VLDL) from baseline (week 0) to week 56. Results based on FAS in-trial data is presented. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Change From Baseline in Lipids - TG | Observed mean change from baseline in triglyceride (TG) from baseline (week 0) to week 56. Results based on FAS in-trial data is presented. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Change From Baseline in Lipids - FFA | Observed mean change from baseline in free fatty acids (FFA) from baseline (week 0) to week 56. Results based on FAS in-trial data is presented. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Change in Short Form-36 v2.0 Acute (SF-36) (Subdomains) | SF-36 is a 36-item patient-reported survey of patient health that measures the subject'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 in the sub-domain scores is presented. A positive change score indicates an improvement since baseline. Results are evaluated based on in-trial data. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | scores on a scale | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | |
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| Secondary | Change in Short Form-36 v2.0 Acute (SF-36) (Physical Component Summary (PCS)) | Observed mean change from baseline (week 0) to week 56 in short form 36 v2.0 acute domain physical component summary (PCS). 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 SF-36 physical component summary (PCS) score is presented. A positive change score indicates an improvement since baseline. The endpoint was evaluated based on in-trial data and on-drug data. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | scores on a scale | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | |
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| Secondary | Change in Short Form-36 v2.0 Acute (SF-36) (Mental Component Summary (MCS) | Observed mean change from baseline (week 0) to week 56 in short form 36 v2.0 acute domain mental component summary (MCS). 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 SF-36 mental component summary is presented. A positive change score indicates an improvement since baseline. The endpoint was evaluated based on in-trial data and on-drug data. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | scores on a scale | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | |
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| Secondary | Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Pain/Discomfort Domain Score | Observed mean change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT) domain pain and discomfort. IWQoL-Lite for CT (Weight on Quality of Life-Lite for Clinical Trial Version) 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. Results based on FAS in-trial data is presented. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | scores on a scale | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
|
| Secondary | Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Psychosocial Domain Score | Observed mean change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT) psychosocial domain. IWQoL-Lite for CT (Weight on Quality of Life-Lite for Clinical Trial Version) 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. Results based on FAS in-trial data is presented. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | score | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
|
| Secondary | Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Total Score | Observed mean change from baseline (week 0) to week 56 in IWQoL-Lite for CT total score. IWQoL-Lite for CT (Weight on Quality of Life-Lite for Clinical Trial Version) 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. Results based on FAS in-trial data is presented. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | scores on a scale | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Change in Weight Related Sign and Symptom (WRSS) Measure, Total Score | Observed mean change from baseline (week 0) to week 56 in WRSS measure, total score. The WRSS measures the presence and bothersome associated with weight-related symptoms. The WRSS questionnaire was not validated until after database lock. Therefore the total score couldn't be calculated and the supportive secondary endpoint "Weight related sign and symptom (WRSS) measure, total score" couldn't be analysed. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | Score on a scale | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 4.3 T-score Points Increase From Baseline in SF-36 Physical Functioning Score | Percentage of subjects who achieved ≥ 4.3 T-score points increase from baseline in SF-36 physical functioning score at week 56 is presented. Results based on FAS in-trial data is presented. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Number | | percentage of participants | | Week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 3.8 T-score Points Increase From Baseline in SF-36 Physical Component Score | Percentage of subjects who achieved ≥ 3.8 T-score points increase from baseline in SF-36 physical component score at week 56 is presented. Results based on FAS in-trial data is presented. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Number | | Percentage of participants | | Week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 4.6 T-score Points Increase From Baseline in SF-36 Mental Component Score | Percentage of subjects who achieved ≥ 4.6 T-score points increase from baseline in SF-36 mental component score at week 56 is presented. Results based on FAS in-trial data is presented. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Number | | Percentage of participants | | Week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
| |
| Secondary | Responder Definition Value for IWQoL-Lite for CT Physical Function Domain (5-items) Score | Responder definition value for IWQoL-Lite for CT physical function domain (5-items) score' was defined as '≥ 20 responder definition value for IWQoL-Lite for CT physical function domain (5-items) score. Percentage of subjects considered IWQoL-Lite for CT physical function domain score responders (increase of ≥20 points) at week 56 is presented. Results based on FAS in-trial data is presented. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Number | | Percentage of participants | | Week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Trial Product | Adherence to trial product is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to trial product is presented. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | weeks | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
| |
| Secondary | Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet | Adherence to caloric diet is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to caloric diet is presented. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | weeks | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
| |
| Secondary | Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Physical Activity | Adherence to physical activity is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to physical activity is presented. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | weeks | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet and Physical Activity | Adherence to caloric diet and physical activity is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to caloric diet and physical activity is presented. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | weeks | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet, Physical Activity and Trial Product | Adherence to caloric diet, physical activity and trial product is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to caloric diet, physical activity and trial product is presented. | Full analysis set included all randomised subjects. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | weeks | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | AEs From Randomisation Until and Including the Follow-up Period | Number of adverse events from randomisation to until the end of the post-treatment follow-up period (30 days). Results based on SAS on-drug data is presented. | Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data. | Posted | | Number | | events | | Week 0 to week 56+30 days | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Change in Physical Examination | Observed change from baseline to week 56 in physical examination are categorised under parameters namely abdomen, gastrointestinal system, cardiovascular system, central and peripheral nervous system, general appearence, head, ears, eyes, nose, throat and neck, lymph node palpation, musculoskeletal system, respiratory system, skin and thyroid gland. The percentage of subjects assessed as normal, abnormal not clinically significant and abnormal clinically significant at baseline and week 56 is presented. | Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data. | Posted | | Number | | participants | | Week 1, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Change in Resting Pulse | Observed mean change in pulse rate measured at resting position is presented. | Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | beats/min | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Change in 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 subjects in each ECG category at baseline and week 56 are presented. | Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data. | Posted | | Number | | participants | | Week -1, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Change in Laboratory Measurements: Haematology (Haemoglobin Blood) | Observed mean change from baseline in haematological parameter blood haemoglobin. | Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Change in Laboratory Measurements: Haematology (Haematocrit Blood) | Observed mean change from baseline in haematological parameter blood haematocrit. Haematocrit is presented as the percentage of red blood cells in total blood. Results based on SAS on-drug data is presented. | Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | percentage of red blood cells | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Change in Laboratory Measurements: Haematology (Erythrocytes) | Observed mean change from baseline in haematological parameter - erythrocytes. | Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | 10^12 cells/L | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Change in Laboratory Measurements: Haematology (Thrombocytes and Leukocytes) | Observed mean change from baseline in haematological parameters - thrombocytss and leukocytes. | Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
| |
| Secondary | Change in Laboratory Measurements: Biochemistry (Albumin) | Observed mean change from baseline in biochemical parameter - albumin. Results based on SAS on-drug data is presented. | Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | g/L | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Change in Laboratory Measurements: Biochemistry (Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase) | Observed mean change from baseline in biochemical parameters - alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase and lipase. Results based on SAS on-drug data is presented. | Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | U/L | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Change in Laboratory Measurements: Biochemistry (Bilirubin and Creatinine) | Observed mean change from baseline in biochemical parameters - bilirubin and creatinine. Results based on SAS on-drug data is presented. | Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | umol/L | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Change in Laboratory Measurements: Biochemistry (Total Calcium, Pottassium, Sodium and Urea) | Observed mean change from baseline in biochemical parameters - total calcium, pottassium, sodium and urea. Results based on SAS on-drug data is presented. | Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
| |
| Secondary | Change in Laboratory Measurements: Biochemistry (C-reactive Protein and Uric Acid) | Observed mean change from baseline in biochemical parameters - high sensitive c-reactive protein and uric acid. Results based on SAS on-drug data is presented. | Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | mg/dL | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
| |
| Secondary | Change in Laboratory Measurements: Biochemistry (Glomerular Filtration Rate, Serum) | Observed mean change from baseline in biochemical parameters - estimated glomerular filtration rate. Serum GFR is estimated using MDRD formula . Results based on SAS on-drug data is presented. | Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | mL/min/1.73m^2 | | Week 0, week 56 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Change in Laboratory Measurements: Biochemistry (Calcitonin) | Observed mean change from baseline in biochemical parameter - calcitonin. Results based on SAS on-drug data is presented. | Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | ng/L | | Week 0, week 56 | | | | ID | Title | Description |
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| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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| Secondary | Change in Laboratory Measurements: Biochemistry (Thyroid Stimulating Hormone) | Observed mean change from baseline in biochemical parameters - thyroid stimulating hormone. Results based on SAS on-drug data is presented. | Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data. | Posted | | Mean | Standard Deviation | mIU/L | | Week 0, week 56 | | | | ID | Title | Description |
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| OG000 | Liraglutide 3.0 mg | Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. | | OG001 | Placebo | Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. |
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