| Primary | Change in Glycosylated A1c (HbA1c) at Week 26 | Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation) | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug. | Posted | | Least Squares Mean | Standard Error | percentage point of total HbA1c | | week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-1.12± 0.08
- OG001-0.79± 0.08
|
|
| | 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, country and previous OAD treatment as fixed effects and baseline HbA1c as covariate. 2 hypotheses were tested: H01: µliraglutide ≥ µexenatide + Δ, HA1: µliraglutide < µexenatide + Δ; Δ=0.4%. If non-inferiority was concluded, a test for superiority was established by a 1-sided test of the hypothesis H02: µliraglutide ≥ µexenatide against HA2: µliraglutide < µexenatide. Superiority was concluded if the upper limit of the 2-sided 95% CI for the difference was below 0%. | ANCOVA | | <.0001 | | Estimated treatment difference, LS Mean | -0.33 | | | | 95 | -0.47 | -0.18 | | | | | Non-Inferiority or Equivalence |
|
| Secondary | Change in Glycosylated A1c (HbA1c), Weeks 26-78 | Percentage point change in glycosylated A1c (HbA1c) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group) | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs. | Posted | | Mean | Standard Deviation | percentage point of total HbA1c | | week 26, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Glycosylated A1c (HbA1c) at Week 78 | Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group) | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs. | Posted | | Mean | Standard Deviation | percentage point of total HbA1c | | week 0, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26 | Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 26 (end of randomisation) | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug. | Posted | | Number | | percentage (%) of subjects | | week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78 | Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 78 (end of treatment) | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs. | Posted | | Number | | percentage (%) of subjects | | week 0, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Body Weight at Week 26 | Change in body weight from baseline (week 0) to 26 weeks (end of randomisation) | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug. | Posted | | Least Squares Mean | Standard Error | kg | | week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Body Weight, Weeks 26-78 | Change in body weight from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group) | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs. | Posted | | Mean | Standard Deviation | kg | | week 26, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Body Weight at Week 78 | Change in body weight from baseline (Week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group) | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs. | Posted | | Mean | Standard Deviation | kg | | week 0, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Fasting Plasma Glucose at Week 26 | Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation) | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug. | Posted | | Least Squares Mean | Standard Error | mmol/L | | week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Fasting Plasma Glucose, Weeks 26-78 | Change in fasting plasma glucose from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group) | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs. | Posted | | Mean | Standard Deviation | mmol/L | | week 26, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Fasting Plasma Glucose at Week 78 | Change in fasting plasma glucose from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group) | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs. | Posted | | Mean | Standard Deviation | mmol/L | | week 0, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26 | Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after breakfast. | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug. | Posted | | Least Squares Mean | Standard Error | mmol/L | | week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26 | Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch. | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug. | Posted | | Least Squares Mean | Standard Error | mmol/L | | week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 26 | Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner. | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug. | Posted | | Least Squares Mean | Standard Error | mmol/L | | week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78 | Change in mean prandial increment of plasma glucose after breakfast from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast. | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs. | Posted | | Mean | Standard Deviation | mmol/L | | week 26, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78 | Change in mean prandial increment of plasma glucose after lunch from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after a lunch. | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs. | Posted | | Mean | Standard Deviation | mmol/L | | week 26, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78 | Change in mean prandial increment of plasma glucose after dinner from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner. | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs. | Posted | | Mean | Standard Deviation | mmol/L | | week 26, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78 | Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast. | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs. | Posted | | Mean | Standard Deviation | mmol/L | | week 0, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78 | Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch. | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs. | Posted | | Mean | Standard Deviation | mmol/L | | week 0, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78 | Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner. | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs. | Posted | | Mean | Standard Deviation | mmol/L | | week 0, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 26 | Change in mean postprandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast. | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug. | Posted | | Least Squares Mean | Standard Error | mmol/L | | week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 26 | Change in mean postprandial increment of plasma glucose after lunch from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch. | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug. | Posted | | Least Squares Mean | Standard Error | mmol/L | | week 0. week 26 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 26 | Change in mean postprandial increment of plasma glucose after dinner from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner. | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug. | Posted | | Least Squares Mean | Standard Error | mmol/L | | week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Mean Postprandial Increment of Plasma Glucose After Breakfast, Weeks 26-78 | Change in mean postprandial increment of plasma glucose after breakfast from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast. | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs. | Posted | | Mean | Standard Deviation | mmol/L | | week 26, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Mean Postprandial Increment of Plasma Glucose After Lunch, Weeks 26-78 | Change in mean postprandial increment of plasma glucose after lunch from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch. | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs. | Posted | | Mean | Standard Deviation | mmol/L | | week 26, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Mean Postprandial Increment of Plasma Glucose After Dinner, Weeks 26-78 | Change in mean postprandial increment of plasma glucose after dinner from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner. | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs. | Posted | | Mean | Standard Deviation | mmol/L | | week 26, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 78 | Change in mean postprandial increment of plasma glucose after breakfast from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast. | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs. | Posted | | Mean | Standard Deviation | mmol/L | | week 0, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 78 | Change in mean postprandial increment of plasma glucose after lunch from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch. | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs. | Posted | | Mean | Standard Deviation | mmol/L | | week 0, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78 | Change in mean postprandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner. | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs. | Posted | | Mean | Standard Deviation | mmol/L | | week 0, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Beta-cell Function at Week 26 | Change in Beta-cell function from baseline (week 0) to 26 weeks (end of randomisation). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B). Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5). | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug. | Posted | | Least Squares Mean | Standard Error | percentage point (%point) | | week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Beta-cell Function, Weeks 26-78 | Change in Beta-cell function from Week 26 (end of randomisation) to Week 78 (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B). Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5). | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs. | Posted | | Mean | Standard Deviation | percentage point (%point) | | week 26, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Beta-cell Function at Week 78 | Change in Beta-cell function from baseline (week 0) to 78 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B). Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5). | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs. | Posted | | Mean | Standard Deviation | percentage point (%point) | | week 0, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Total Cholesterol at Week 26 | Change in total cholesterol (TC) from baseline (week 0) to 26 weeks (end of randomisation) | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug. | Posted | | Least Squares Mean | Standard Error | mmol/L | | week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Total Cholesterol, Weeks 26-78 | Change in total cholesterol (TC) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group). | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the trial products. | Posted | | Mean | Standard Deviation | mmol/L | | week 26, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Total Cholesterol at Week 78 | Change in total cholesterol (TC) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group). | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products. | Posted | | Mean | Standard Deviation | mmol/L | | week 0, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Low-density Lipoprotein-cholesterol at Week 26 | Change in Low-density Lipoprotein-cholesterol (LDL-C) from baseline (week 0) to 26 weeks (end of randomisation) | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug. | Posted | | Least Squares Mean | Standard Error | mmol/L | | week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Low-density Lipoprotein-cholesterol, Weeks 26-78 | Change in low-density lipoprotein-cholesterol (LDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group). | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products. | Posted | | Mean | Standard Deviation | mmol/L | | week 26, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Low-density Lipoprotein-cholesterol at Week 78 | Change in Low-density Lipoprotein-cholesterol (LDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group). | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products. | Posted | | Mean | Standard Deviation | mmol/L | | week 0, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Very Low-density Lipoprotein-cholesterol at Week 26 | Change in very low-density lipoprotein-cholesterol (VLDL-C) from baseline (week 0) to 26 weeks (end of randomisation) | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug. | Posted | | Least Squares Mean | Standard Error | mmol/L | | week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Very Low-density Lipoprotein-cholesterol, Weeks 26-78 | Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group). | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products. | Posted | | Mean | Standard Deviation | mmol/L | | week 26, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Very Low-density Lipoprotein-cholesterol at Week 78 | Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group). | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products. | Posted | | Mean | Standard Deviation | mmol/L | | week 0, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in High-density Lipoprotein-cholesterol at Week 26 | Change in High-density Lipoprotein-cholesterol (HDL-C) from baseline (week 0) to 26 weeks (end of randomisation) | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug. | Posted | | Least Squares Mean | Standard Error | mmol/L | | week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in High-density Lipoprotein-cholesterol, Weeks 26-78 | Change in High-density Lipoprotein-cholesterol (HDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group). | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products. | Posted | | Mean | Standard Deviation | mmol/L | | week 26, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in High-density Lipoprotein-cholesterol at Week 78 | Change in High-density Lipoprotein-cholesterol (HDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group). | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products. | Posted | | Mean | Standard Deviation | mmol/L | | week 0, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Triglyceride at Week 26 | Change in triglyceride (TG) from from baseline (week 0) to 26 weeks (end of randomisation) | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug. | Posted | | Least Squares Mean | Standard Error | mmol/L | | week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Triglyceride, Weeks 26-78 | Change in Triglyceride (TG) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group). | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products. | Posted | | Mean | Standard Deviation | mmol/L | | week 26, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Triglyceride at Week 78 | Change in triglyceride (TG) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group). | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products. | Posted | | Mean | Standard Deviation | mmol/L | | week 0, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Free Fatty Acid at Week 26 | Change in Free Fatty Acid (FFA) from baseline (week 0) to 26 weeks (end of randomisation) | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug. | Posted | | Least Squares Mean | Standard Error | mmol/L | | week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Free Fatty Acid, Weeks 26-78 | Change in Free Fatty Acid (FFA) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group). | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products. | Posted | | Mean | Standard Deviation | mmol/L | | week 26, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Free Fatty Acid at Week 78 | Change in Free Fatty Acid (FFA) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group). | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products. | Posted | | Mean | Standard Deviation | mmol/L | | week 0, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Apolipoprotein B at Week 26 | Change in apolipoprotein B (ApoB) from baseline (week 0) to 26 weeks (end of randomisation) | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug. | Posted | | Least Squares Mean | Standard Error | g/L | | week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Apolipoprotein B, Weeks 26-78 | Change in apolipoprotein B (ApoB) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group). | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products. | Posted | | Mean | Standard Deviation | g/L | | week 26, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Change in Apolipoprotein B at Week 78 | Change in apolipoprotein B (ApoB) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group). | Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products. | Posted | | Mean | Standard Deviation | g/L | | week 0, week 78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Hypoglycaemic Episodes at Week 26 | Total number of hypoglycaemic episodes occurring after baseline (week 0) and until week 26 (end of randomisation). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. | The safety analysis set is all subjects who had been exposed to at least one dose of the study products. | Posted | | Number | | episodes | | weeks 0-26 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |
| Secondary | Hypoglyceamic Episodes, Weeks 26-78 | Total number of hypoglycaemic episodes occurring after end of randomisation (week 26) and until week 78 (end of treatment). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. | The safety analysis set is all subjects who had been exposed to at least one dose of the study products. | Posted | | Number | | episodes | | weeks 26-78 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide -> Liraglutide -> Liraglutide | Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | | OG001 | Exenatide -> Liraglutide -> Liraglutide | Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) |
| |