| Primary | Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26 | Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | Percentage point of total HbA1c | | Week 0, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). | | OG003 | Sita -> Sita -> Lira 1.2 mg | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. | | OG004 | Sita -> Sita -> Lira 1.8 mg | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin. |
| | Units | Counts |
|---|
| Participants | - OG000211
- OG001214
- OG002210
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-1.24± 0.07
- OG001-1.5± 0.06
- OG002-0.9± 0.07
|
|
| | 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 |
|---|
| ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate. Hieracheal testing of non-inferiority followed by superiority. | ANCOVA | Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate). | 0.0001 | Multiple comparisons not applicable due to the hieracheal testing. | Estimated treatment difference, LS Mean | -0.6 | | | | 95 | -0.77 | -0.43 | | | | | Non-Inferiority or Equivalence | Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%. |
|
| Primary | Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 | Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | Percentage point of total HbA1c | | Week 0, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | |
|
| Primary | Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78 | Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | Percentage point of total HbA1c | | Week 0, Week 78 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | |
|
| Primary | Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78 | Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78 | Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78) | Posted | | Mean | Standard Deviation | Percentage point of total HbA1c | | Week 52, Week 78 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | |
|
| Secondary | Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26 | Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26 | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Number | | percentage of subjects | | Week 0, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52 | Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 52 | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Number | | percentage of subjects | | Week 0, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78 | Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the FAS. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Number | | percentage of subjects | | Week 0, Week 78 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78 | Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the extension 2 FAS. | Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78) | Posted | | Number | | percentage of subjects | | Week 0, Week 78 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | |
|
| Secondary | Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26 | Calculated as the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 26 | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Number | | percentage of subjects | | Week 0, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52 | Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 52 | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Number | | percentage of subjects | | Week 0, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78 | Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the FAS. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Number | | percentage of subjects | | Week 0, Week 78 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78 | Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the extension 2 FAS. | Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78) | Posted | | Number | | percentage of subjects | | Week 0, Week 78 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | |
|
| Secondary | Mean Change From Baseline in Body Weight at Week 26 | Calculated as an estimate of the mean change from baseline in body weight at Week 26. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | kg | | Week 0, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change From Baseline in Body Weight at Week 52 | Calculated as an estimate of the mean change from baseline in body weight at Week 52. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | kg | | Week 0, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change in Body Weight From Week 52 to Week 78 | Mean change in body weight from Week 52 to Week 78. | Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78) | Posted | | Mean | Standard Deviation | kg | | Week 52, Week 78 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 | Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | mmol/L | | Week 0, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 | Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | mmol/L | | Week 0, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78 | Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | mmol/L | | Week 0, Week 78 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78 | Mean change in fasting plasma glucose (FPG) Week 52 to Week 78. | Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78) | Posted | | Mean | Standard Deviation | mmol/L | | Week 52, Week 78 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change From Baseline in Beta-cell Function at Week 26 | Calculated as an estimate of the mean change from baseline in beta-cell function at Week 26. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B). | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | percentage point | | Week 0, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | |
|
| Secondary | Mean Change From Baseline in Beta-cell Function at Week 52 | Calculated as an estimate of the mean change from baseline in beta-cell function at Week 52. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B). | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | percentage point | | Week 0, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | |
|
| Secondary | Mean Change in Beta-cell Function From Week 52 to Week 78 | Mean change in beta-cell function from Week 52 to Week 78. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B). | Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78) | Posted | | Mean | Standard Deviation | percentage point | | Week 52, Week 78 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 |
|
| Secondary | Mean Change From Baseline in Total Cholesterol at Week 26 | Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | mmol/L | | Week 0, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change From Baseline in Total Cholesterol at Week 52 | Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | mmol/L | | Week 0, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change in Total Cholesterol From Week 52 to Week 78 | Mean change in total cholesterol from Week 52 to Week 78 | Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78) | Posted | | Mean | Standard Deviation | mmol/L | | Week 52, Week 78 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26 | Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 26. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | mmol/L | | Week 0, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52 | Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 52. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | mmol/L | | Week 0, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78 | Mean change in low-density lipoprotein-cholesterol (LDL-C) from week 52 to Week 78. | Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78) | Posted | | Mean | Standard Deviation | mmol/L | | Week 52, Week 78 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26 | Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 26. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | mmol/L | | Week 0, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | |
|
| Secondary | Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52 | Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 52. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | mmol/L | | Week 0, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | |
|
| Secondary | Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78 | Mean change in high-density lipoprotein-cholesterol (HDL-C) from Week 52 to Week 78. | Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78) | Posted | | Mean | Standard Deviation | mmol/L | | Week 52, Week 78 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26 | Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 26. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | mmol/L | | Week 0, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | |
|
| Secondary | Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 | Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 52. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | mmol/L | | Week 0, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | |
|
| Secondary | Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78 | Mean change in very low-density lipoprotein-cholesterol (VLDL-C) from Week 52 to Week 78. | Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78) | Posted | | Mean | Standard Deviation | mmol/L | | Week 52, Week 78 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | |
|
| Secondary | Mean Change From Baseline in Triglycerides (TG) at Week 26 | Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 26. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | mmol/L | | Week 0, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change From Baseline in Triglycerides (TG) at Week 52 | Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 52. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | mmol/L | | Week 0, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change in Triglycerides (TG) From Week 52 to Week 78 | Mean change in triglycerides (TG) from Week 52 to Week 78. | Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78) | Posted | | Mean | Standard Deviation | mmol/L | | Week 52, Week 78 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26 | Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 26. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | mmol/L | | Week 0, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52 | Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 52. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | mmol/L | | Week 0, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78 | Mean change in free fatty acids (FFA) from Week 52 to Week 78. | Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78) | Posted | | Mean | Standard Deviation | mmol/L | | Week 52, Week 78 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change From Baseline in Apolipoprotein B at Week 26 | Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 26. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | g/L | | Week 0, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change From Baseline in Apolipoprotein B at Week 52 | Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 52. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | g/L | | Week 0, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change in Apolipoprotein B From Week 52 to Week 78 | Mean change in apolipoprotein B (ApoB) from Week 52 to Week 78. | Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78) | Posted | | Mean | Standard Deviation | mmol/L | | Week 52, Week 78 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26 | Calculated as an estimate of the mean change from baseline in highly sensitive C-reactive protein (hsCRP) at week 26. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | mg/L | | Week 0, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26. | Calculated as an estimate of the mean change from baseline in plasminogen activator inhibitor-1 (PAI-1) at Week 26. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | U/L | | Week 0, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26. | Calculated as an estimate of the mean change from baseline in interleukin-6 (IL-6) at Week 26. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | pg/mL | | Week 0, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26. | Calculated as an estimate of the mean change from baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at Week 26. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | pmol/L | | Week 0, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | |
|
| Secondary | Mean Change From Baseline in Adiponectin at Week 26. | Calculated as an estimate of the mean change from baseline in Adiponectin at Week 26. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | mcg/mL | | Week 0, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26. | Calculated as an estimate of the mean change from baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | pg/mL | | Week 0, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26. | Calculated as an estimate of the mean change from baseline in von Willebrand Factor (vWf) at Week 26. vWf is a blood glycoprotein involved in haemostasis. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | percentage point | | Week 0, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | |
|
| Secondary | Mean Change From Baseline in Waist to Hip Ratio at Week 26. | Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 26. The measure is assessed as the circumference of the waist divided by the circumference of the hip. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | cm/cm | | Week 0, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | |
|
| Secondary | Mean Change From Baseline in Waist to Hip Ratio at Week 52 | Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 52. The measure is assessed as the circumference of the waist divided by the circumference of the hip. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | cm/cm | | Week 0, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | |
|
| Secondary | Mean Change in Waist to Hip Ratio From Week 52 to Week 78 | Mean change in Waist to Hip Ratio from Week 52 to Week 78. The measure is assessed as the circumference of the waist divided by the circumference of the hip. | Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78) | Posted | | Mean | Standard Deviation | cm/cm | | Week 52, Week 78 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | |
|
| Secondary | Mean Change From Baseline in Waist Circumference at Week 26. | Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 26 | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | cm | | Week 0, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change From Baseline in Waist Circumference at Week 52 | Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 52. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | participants | | Week 0, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change in Waist Circumference From Week 52 to Week 78 | Mean change in Waist Circumference from Week 52 to Week 78. | Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78) | Posted | | Mean | Standard Deviation | kg | | Week 52, Week 78 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26 | Calculated as an estimate of the mean change from baseline in Systolic Blood Pressure (SBP) at Week 26 | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | mmHg | | Week 0, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52 | Calculated as an estimate of the mean change from baseline in systolic blood pressure (SBP) at Week 52. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | mmHg | | Week 0, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78 | Mean change in systolic blood pressure (SBP) from Week 52 to Week 78. | Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78) | Posted | | Mean | Standard Deviation | mmHg | | Week 52, Week 78 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26 | Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 26. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | mmHg | | Week 0, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52 | Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 52. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | mmHg | | Week 0, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78 | Mean change in diastolic blood pressure (DBP) from Week 52 to Week 78. | Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78) | Posted | | Mean | Standard Deviation | mmHg | | Week 52, Week 78 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change From Baseline in Pulse at Week 26 | Calculated as an estimate of the mean change from baseline in pulse at Week 26. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | beats/minute | | Week 0, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change From Baseline in Pulse at Week 52 | Calculated as an estimate of the mean change from baseline in pulse at Week 52. | FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug. | Posted | | Least Squares Mean | Standard Error | mmHg | | Week 0, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change in Pulse From Week 52 to Week 78 | Mean change in pulse from Week 52 to Week 78. | Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78) | Posted | | Mean | Standard Deviation | beats/minute | | Week 52, Week 78 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
|
| Secondary | Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26 | The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36. | Patient Reported Outcome Analysis Set consisted of all subjects in the FAS, except subjects from countries Serbia, Slovakia and Slovenia | Posted | | Least Squares Mean | Standard Error | scores on a scale | | Week 0, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 |
|
| Secondary | Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52 | The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36. | Patient Reported Outcome Analysis Set consisted of all subjects in the FAS, except subjects from countries Serbia, Slovakia and Slovenia | Posted | | Least Squares Mean | Standard Error | scores on a scale | | Week 0, Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 |
|
| Secondary | Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78 | The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36. | Extension 2 Patient Reported Outcome Analysis Set consisted of all subjects in the Extension 2 FAS, except subjects from countries Serbia, Slovakia and Slovenia | Posted | | Mean | Standard Deviation | scores on a scale | | Week 52, Week 78 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | |
|
| Secondary | Hypoglyceamic Episodes, Weeks 0-26 | Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. | The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. | Posted | | Number | | episodes | | Weeks 0-26 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita |
|
| Secondary | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 | Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. | The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 21 minor hypoglycaemic episodes was excluded from this analysis. | Posted | | Number | | episodes | | Weeks 0-26 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). |
|
| Secondary | Hypoglyceamic Episodes, Weeks 0-52 | Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. | The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. | Posted | | Number | | episodes | | Weeks 0-52 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita |
|
| Secondary | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52 | Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. | The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 23 minor hypoglycaemic episodes was excluded from this analysis. | Posted | | Number | | episodes | | Weeks 0-52 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). |
|
| Secondary | Hypoglyceamic Episodes, Weeks 0-78 | Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. | The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. | Posted | | Number | | episodes | | Weeks 0-78 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG002 | Sita -> Sita |
|
| Secondary | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78 | Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. | The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 23 minor hypoglycaemic episodes was excluded from this analysis. | Posted | | Number | | episodes | | Weeks 0-78 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). |
|
| Secondary | Hypoglycaamic Episodes, Weeks 52-78 | Number of hypoglycaemic episodes from Week 52 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. | Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78) | Posted | | Number | | episodes | | Week 52-78 | | | | ID | Title | Description |
|---|
| OG000 | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | | OG001 | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | |
|