| Primary | Change in Glycosylated Haemoglobin (HbA1c) From Baseline | Change from baseline in HbA1c after 26 weeks of treatment. | The full analysis set (FAS) included all randomised subjects. Missing values were imputed using predicted values from the mixed model for repeated measurements (MMRM) model. Due to missing HbA1c post baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the HbA1c analysis. | Posted | | Mean | Standard Deviation | Percent (%) glycosylated haemoglobin | | Week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide | Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached. | | OG001 | Lixisenatide | Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-1.809± 0.9159
- OG001-1.238± 1.0085
|
|
| |
| Secondary | Change in Fasting Plasma Glucose (FPG) From Baseline | Change from baseline in FPG after 26 weeks of treatment. | The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing FPG post baseline data, 194 and 189 subjects in liraglutide and lixisenatide treatment group, respectively were included in the FPG analysis. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide | Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached. | | OG001 | Lixisenatide | Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation. |
| |
| Secondary | Change in Body Weight From Baseline | Change from baseline in body weight after 26 weeks of treatment. | The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing body weight post baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the body weight analysis. | Posted | | Mean | Standard Deviation | kg | | Week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide | Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached. | | OG001 | Lixisenatide | Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation. |
| |
| Secondary | Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no) | Subjects who achieved HbA1c below 7.0% (53 mmol/mol) after 26 weeks of treatment (yes/no). | The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing HbA1c post baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the HbA1c analysis. | Posted | | Number | | percentage (%) of subjects | | After 26 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide | Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached. | | OG001 | Lixisenatide | Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation. |
|
| Secondary | Subjects Who Achieve HbA1c Equal to or Below 6.5% (48 mmol/Mol) (American Association of Clinical Endocrinologists [AACE] Target) (Yes/no) | Subjects who achieved HbA1c below equal to or below 6.5% (48 mmol/mol) after 26 weeks of treatment (yes/no). | The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing HbA1c post baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the HbA1c analysis. | Posted | | Number | | percentage (%) of subjects | | After 26 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide | Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached. | | OG001 | Lixisenatide | Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation. |
|
| Secondary | Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) and no Weight Gain (Yes/no) | Subjects who achieved HbA1c below 7.0% (53 mmol/mol) and no weight gain after 26 weeks of treatment (yes/no). | The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing HbA1c post-baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the HbA1c analysis. | Posted | | Number | | percentage (%) of subjects | | After 26 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide | Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached. | | OG001 | Lixisenatide | Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation. |
|
| Secondary | Number of Treatment Emergent Adverse Events (TEAEs) | A Treatment Emergent Adverse Event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator. | The safety analysis set (SAS) included all subjects who received at least one dose of any of the trial products. | Posted | | Number | | events | | Weeks 0-26 | | | | ID | Title | Description |
|---|
| OG000 | Liraglutide | Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached. | | OG001 | Lixisenatide | Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation. |
| |