| Primary | Change in Glycosylated Haemoglobin A1c (HbA1c) | Calculated as an estimate of the mean change in HbA1c after 16 weeks of treatment. | Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. | Posted | | Least Squares Mean | Standard Error | percentage (%) of total haemoglobin | | week -2 (screening), week 16 | | | | ID | Title | Description |
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| OG000 | Repaglinide + Metformin | Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily. | | OG001 | Repaglinide | Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-4.450± 0.070
- OG001-4.148± 0.071
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| The non-inferiority margin for HbA1c was set to 0.4%. The null hypothesis (H0) was: H0: HbA1c of repaglinide + metformin therapy after 16 weeks of treatment - HbA1c of repaglinide monotherapy after 16 weeks of treatment ≥0.4% Against the alternative hypothesis (H1): H1: HbA1c of repaglinide + metformin therapy after 16 weeks of treatment - HbA1c of repaglinide monotherapy after 16 weeks of treatment <0.4% | ANCOVA | | | | Estimated treatment difference, LS Mean | -0.302 | Standard Error of the Mean | 0.0096 | | 95 | -0.491 | -0.114 | | | | Yes | Non-Inferiority or Equivalence | |
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| Secondary | Change in Fasting Plasma Glucose | Calculated as an estimate of the mean change in fasting plasma glucose after 16 weeks of treatment. | Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. | Posted | | Least Squares Mean | Standard Error | mmol/L | | week 0, week 16 | | | | ID | Title | Description |
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| OG000 | Repaglinide + Metformin | Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily. | | OG001 | Repaglinide | Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily. |
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| Secondary | Change in 2-hour Postprandial Plasma Glucose | Calculated as an estimate of the mean change in 2-hour postprandial plasma glucose following a standard test meal after 16 weeks of treatment | Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. | Posted | | Least Squares Mean | Standard Error | mmol/L | | Week 0, week 16 | | | | ID | Title | Description |
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| OG000 | Repaglinide + Metformin | Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily. | | OG001 | Repaglinide | Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily. |
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| Secondary | Change in 7-point Plasma Glucose Profile | Calculated as an estimate of the mean change in 7-point (before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, bedtime) plasma glucose profile after 16 weeks of treatment. | Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. | Posted | | Least Squares Mean | Standard Error | mmol/L | | Week 0, week 16 | | | | ID | Title | Description |
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| OG000 | Repaglinide + Metformin | Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily. | | OG001 | Repaglinide | Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily. |
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| Secondary | Change in Fasting Serum Insulin | Calculated as an estimate of the mean change in fasting serum insulin after 16 weeks of treatment. | Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study. | Posted | | Least Squares Mean | Standard Error | mU/L | | Week 0, week 16 | | | | ID | Title | Description |
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| OG000 | Repaglinide + Metformin | Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily. | | OG001 | Repaglinide | Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily. |
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| Secondary | Change in 2-hour Postprandial Serum Insulin | Calculated as an estimate of the mean change in 2-hour postprandial serum insulin after 16 weeks of treatment. | Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study. | Posted | | Least Squares Mean | Standard Error | mU/L | | Week 0, week 16 | | | | ID | Title | Description |
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| OG000 | Repaglinide + Metformin | Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily. | | OG001 | Repaglinide | Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily. |
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| Secondary | Change in Fasting Serum C-peptide | Calculated as an estimate of the mean change in fasting serum C-peptide after 16 weeks of treatment | Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study. | Posted | | Least Squares Mean | Standard Error | ng/ml | | Week 0, week 16 | | | | ID | Title | Description |
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| OG000 | Repaglinide + Metformin | Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily. | | OG001 | Repaglinide | Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily. |
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| Secondary | Change in 2-hour Postprandial Serum C-peptide | Calculated as an estimate of the mean change in 2-hour postprandial serum C-peptide after 16 weeks of treatment | Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study. | Posted | | Least Squares Mean | Standard Error | ng/ml | | Week 0, week 16 | | | | ID | Title | Description |
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| OG000 | Repaglinide + Metformin | Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily. | | OG001 | Repaglinide | Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily. |
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| Secondary | Hypoglycaemic Episodes | Number of hypoglycaemic episodes from Week 0 to Week 16, 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. | Safety analysis set was defined as all randomised and exposed subjects. | Posted | | Number | | episodes | | Weeks 0-16 | | | | ID | Title | Description |
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| OG000 | Repaglinide + Metformin | Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily. | | OG001 | Repaglinide | Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily. |
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| Secondary | Change in Blood Pressure | Calculated as the mean change in diastolic and systolic blood pressure after 16 weeks of treatment | Safety analysis set was defined as all randomised and exposed subjects. | Posted | | Mean | Standard Deviation | mmHg | | Week 0, week 16 | | | | ID | Title | Description |
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| OG000 | Repaglinide + Metformin | Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily. | | OG001 | Repaglinide | Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily. |
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| Secondary | Physical Examinations | The number of subjects having a physical examination event that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. Physical examination included cardiovascular system, respiratory system, musculoskeletal system, nervous system and abdomen. | Safety analysis set was defined as all randomised and exposed subjects. | Posted | | Number | | Subjects | | Week -2, week 16 | | | | ID | Title | Description |
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| OG000 | Repaglinide + Metformin | Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily. | | OG001 | Repaglinide | Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily. |
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| Secondary | ECG (ElectroCardioGram) | The number of subjects having a electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management. | Safety analysis set was defined as all randomised and exposed subjects. | Posted | | Number | | Subjects | | Week -2, week 16 | | | | ID | Title | Description |
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| OG000 | Repaglinide + Metformin | Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily. | | OG001 | Repaglinide | Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily. |
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| Secondary | Biochemistry: Alanine Aminotransferase (ALAT) | The number of subjects having a change in Alanine Aminotransferase (ALAT) from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management. | Safety analysis set was defined as all randomised and exposed subjects. | Posted | | Number | | Subjects | | Week -2, week 16 | | | | ID | Title | Description |
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| OG000 | Repaglinide + Metformin | Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily. | | OG001 | Repaglinide | Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily. |
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| Secondary | Biochemistry: Alanine Aminotransferase (ASAT) | The number of subjects having a change in Aspartate Aminotransferase (ASAT) from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management. | Safety analysis set was defined as all randomised and exposed subjects. | Posted | | Number | | Subjects | | Week -2, week 16 | | | | ID | Title | Description |
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| OG000 | Repaglinide + Metformin | Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily. | | OG001 | Repaglinide | Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily. |
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| Secondary | Haematology: Haemoglobin | Haemoglobin was measured. The number of subjects having a change in Haemoglobin measurement from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant' 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management. | Safety analysis set was defined as all randomised and exposed subjects. | Posted | | Number | | Subjects | | Week -2, week 16 | | | | ID | Title | Description |
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| OG000 | Repaglinide + Metformin | Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily. | | OG001 | Repaglinide | Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily. |
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