| Primary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit relative to baseline. | Per Protocol Set (PPS) is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation. | Posted | | Least Squares Mean | Standard Error | percentage of glycated hemoglobin | | Baseline, Week 12 | | | | ID | Title | Description |
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| OG000 | Metformin + Voglibose 0.2 mg | Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to voglibose 0.2 mg, tablets, orally, three times daily, for Weeks 1 and 2, followed by voglibose 0.3 mg, tablets, orally, three times daily, Weeks 3 through 12. | | OG001 | Metformin + Acarbose 50 mg | Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to acarbose 50 mg, tablets, orally, three times daily, Weeks 1 and 2, then acarbose 100 mg, tablets, orally, three times daily, Weeks 3 through 12. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-0.6982± 0.0742
- OG001-0.9335± 0.0764
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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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| | Paired t-test | | 0.0001 | | | | | | | | | | | | | | Non-Inferiority or Equivalence | If the upper limit of 95% CI of Least Square Mean (LS mean) of HbA1C Changes was less than 0.4%, it was considered that the non-inferiority was established. | |
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| Secondary | Change From Baseline in HbA1c at Week 6 | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 6 relative to baseline. | PPS is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation. | Posted | | Least Squares Mean | Standard Error | percentage of glycated hemoglobin | | Baseline and Week 6 | | | | ID | Title | Description |
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| OG000 | Metformin + Voglibose 0.2 mg | Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to voglibose 0.2 mg, tablets, orally, three times daily, for Weeks 1 and 2, followed by voglibose 0.3 mg, tablets, orally, three times daily, Weeks 3 through 12. | | OG001 | Metformin + Acarbose 50 mg | Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to acarbose 50 mg, tablets, orally, three times daily, Weeks 1 and 2, then acarbose 100 mg, tablets, orally, three times daily, Weeks 3 through 12. |
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| Secondary | Change From Baseline in Fasting Blood Glucose Over Time | The change between the fasting blood glucose value collected at weeks 6 and 12 or final visit relative to baseline. | PPS is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation. | Posted | | Least Squares Mean | Standard Error | mmol/L | | Baseline, Weeks 6 and 12 | | | | ID | Title | Description |
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| OG000 | Metformin + Voglibose 0.2 mg | Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to voglibose 0.2 mg, tablets, orally, three times daily, for Weeks 1 and 2, followed by voglibose 0.3 mg, tablets, orally, three times daily, Weeks 3 through 12. | | OG001 | Metformin + Acarbose 50 mg | Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to acarbose 50 mg, tablets, orally, three times daily, Weeks 1 and 2, then acarbose 100 mg, tablets, orally, three times daily, Weeks 3 through 12. |
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| Secondary | Change From Baseline in Postprandial Plasma Glucose (PPG) Over Time | The change between the value of glucose after 1 and 2 hours of meal, measured by the meal tolerance test collected at Weeks 6 and 12 or relative to baseline. | PPS is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation. | Posted | | Least Squares Mean | Standard Error | mmol/L | | 1 and 2 hours after meal at Baseline, Weeks 6 and 12 | | | | ID | Title | Description |
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| OG000 | Metformin + Voglibose 0.2 mg | Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to voglibose 0.2 mg, tablets, orally, three times daily, for Weeks 1 and 2, followed by voglibose 0.3 mg, tablets, orally, three times daily, Weeks 3 through 12. | | OG001 | Metformin + Acarbose 50 mg | Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to acarbose 50 mg, tablets, orally, three times daily, Weeks 1 and 2, then acarbose 100 mg, tablets, orally, three times daily, Weeks 3 through 12. |
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| Secondary | Change From Baseline in Fasting Insulin at Week 12 | The change between the fasting insulin value collected at week 12 or final visit relative to baseline. | PPS is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation. | Posted | | Least Squares Mean | Standard Error | μU/dL | | Baseline, Week 12 | | | | ID | Title | Description |
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| OG000 | Metformin + Voglibose 0.2 mg | Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to voglibose 0.2 mg, tablets, orally, three times daily, for Weeks 1 and 2, followed by voglibose 0.3 mg, tablets, orally, three times daily, Weeks 3 through 12. | | OG001 | Metformin + Acarbose 50 mg | Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to acarbose 50 mg, tablets, orally, three times daily, Weeks 1 and 2, then acarbose 100 mg, tablets, orally, three times daily, Weeks 3 through 12. |
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| Secondary | Change From Baseline in Postprandial Serum Insulin at Week 12 | The change from Baseline in postprandial serum insulin, after 1 and 2 hours of meal collected at Week 12 relative to baseline. | PPS is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation. | Posted | | Least Squares Mean | Standard Error | μU/dL | | 1 and 2 hours after meal at Baseline and Week 12 | | | | ID | Title | Description |
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| OG000 | Metformin + Voglibose 0.2 mg | Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to voglibose 0.2 mg, tablets, orally, three times daily, for Weeks 1 and 2, followed by voglibose 0.3 mg, tablets, orally, three times daily, Weeks 3 through 12. | | OG001 | Metformin + Acarbose 50 mg | Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to acarbose 50 mg, tablets, orally, three times daily, Weeks 1 and 2, then acarbose 100 mg, tablets, orally, three times daily, Weeks 3 through 12. |
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| Secondary | Change From Baseline in Fasting Glucagon at Week 12 | The change between the fasting glucagon value collected at week 12 or final visit relative to baseline. | PPS is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation. | Posted | | Least Squares Mean | Standard Error | pg/mL | | Baseline, Week 12 | | | | ID | Title | Description |
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| OG000 | Metformin + Voglibose 0.2 mg | Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to voglibose 0.2 mg, tablets, orally, three times daily, for Weeks 1 and 2, followed by voglibose 0.3 mg, tablets, orally, three times daily, Weeks 3 through 12. | | OG001 | Metformin + Acarbose 50 mg | Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to acarbose 50 mg, tablets, orally, three times daily, Weeks 1 and 2, then acarbose 100 mg, tablets, orally, three times daily, Weeks 3 through 12. |
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| Secondary | Change From Baseline in Postprandial Serum Glucagon at Week 12 | The change from Baseline in postprandial serum glucagon, after 1 and 2 hours of meal collected at Week 12 relative to baseline. | PPS is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation. | Posted | | Least Squares Mean | Standard Error | pg/mL | | 1 and 2 hours after meal at Baseline and Week 12 | | | | ID | Title | Description |
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| OG000 | Metformin + Voglibose 0.2 mg | Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to voglibose 0.2 mg, tablets, orally, three times daily, for Weeks 1 and 2, followed by voglibose 0.3 mg, tablets, orally, three times daily, Weeks 3 through 12. | | OG001 | Metformin + Acarbose 50 mg | Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to acarbose 50 mg, tablets, orally, three times daily, Weeks 1 and 2, then acarbose 100 mg, tablets, orally, three times daily, Weeks 3 through 12. |
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| Secondary | Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance (HOMA IR) at Week 12 | The change between the value of HOMA-IR collected at Week 12 and HOMA-IR collected at Baseline. HOMA IR measures insulin resistance based on fasting glucose and insulin measurements: HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5. A higher number indicates a greater insulin resistance. | PPS is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation. | Posted | | Least Squares Mean | Standard Error | Insulin resistance | | Baseline, Week 12 | | | | ID | Title | Description |
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| OG000 | Metformin + Voglibose 0.2 mg | Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to voglibose 0.2 mg, tablets, orally, three times daily, for Weeks 1 and 2, followed by voglibose 0.3 mg, tablets, orally, three times daily, Weeks 3 through 12. | | OG001 | Metformin + Acarbose 50 mg | Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to acarbose 50 mg, tablets, orally, three times daily, Weeks 1 and 2, then acarbose 100 mg, tablets, orally, three times daily, Weeks 3 through 12. |
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| Secondary | Change From Baseline in Insulin Homeostatic Model Assessment Beta Cell Function (HOMA β) at Week 12 | The change between the value of HOMA-beta cell function collected at Week 12 and HOMA-beta cell function collected at Baseline. The homeostatic model assessment estimates steady state beta cell function as a percentage of a normal reference population (%B). HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5. | PPS is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation. | Posted | | Least Squares Mean | Standard Error | Percentage beta cell function | | Baseline, Week 12 | | | | ID | Title | Description |
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| OG000 | Metformin + Voglibose 0.2 mg | Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to voglibose 0.2 mg, tablets, orally, three times daily, for Weeks 1 and 2, followed by voglibose 0.3 mg, tablets, orally, three times daily, Weeks 3 through 12. | | OG001 | Metformin + Acarbose 50 mg | Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to acarbose 50 mg, tablets, orally, three times daily, Weeks 1 and 2, then acarbose 100 mg, tablets, orally, three times daily, Weeks 3 through 12. |
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| Secondary | Change From Baseline in Body Weight Over Time | The change between body weight at weeks 2, 6 and 12 or relative to baseline. | PPS is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation. | Posted | | Least Squares Mean | Standard Error | kg | | Baseline, Weeks 2, 6 and 12 | | | | ID | Title | Description |
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| OG000 | Metformin + Voglibose 0.2 mg | Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to voglibose 0.2 mg, tablets, orally, three times daily, for Weeks 1 and 2, followed by voglibose 0.3 mg, tablets, orally, three times daily, Weeks 3 through 12. | | OG001 | Metformin + Acarbose 50 mg | Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to acarbose 50 mg, tablets, orally, three times daily, Weeks 1 and 2, then acarbose 100 mg, tablets, orally, three times daily, Weeks 3 through 12. |
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