| Primary | Change From Baseline in A1C (%) at Week 26 (Excluding Rescue Approach) | A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 26 A1C minus the Week 0 A1C (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. | The analysis population included all randomized participants who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post baseline up to Week 26. | Posted | | Least Squares Mean | 95% Confidence Interval | Percentage A1C | | Baseline and Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG002 | Placebo | Placebo matching ertugliflozin administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-1.00(-1.12 to -0.88)
- OG001-0.89(-1.01 to -0.77)
- OG002-0.20(-0.33 to -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 |
|---|
| The primary hypothesis of the study was the mean change from baseline in HbA1c for 15 mg ertugliflozin is greater than that for placebo. | cLDA | Least squares means = LSM | <0.001 | cLDA model with fixed effects for treatment, time, anti-AHA status at Screening (metformin alone, metformin + another AHA), country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. | Difference in the LSM vs. placebo | -0.69 | | | 2-Sided | 95 | -0.85 | -0.52 | | | | | Superiority | |
|
| Primary | Change From Baseline in A1C (%) at Week 26 (Excluding Rescue Approach) (China Subpopulation) | A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 26 A1C minus the Week 0 A1C (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. | The analysis population included all randomized participants in China who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post baseline up to Week 26. | Posted | | Least Squares Mean | 95% Confidence Interval | Percentage A1C | | Baseline and Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | |
|
| Primary | Percentage of Participants Experiencing An Adverse Event (AE) (Including Rescue Approach) | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. | The analysis population included all randomized participants who received at least one dose of investigational product. | Posted | | Number | | Percentage of participants | | Up to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG002 | Placebo | |
|
| Primary | Percentage of Participants Experiencing An Adverse Event (AE) (Including Rescue Approach) (China Subpopulation) | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. | The analysis population included all randomized participants in China who received at least one dose of investigational product . | Posted | | Number | | Percentage of participants | | Up to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG002 | Placebo |
|
| Primary | Percentage of Participants Discontinuing Study Treatment Due to an AE (Including Rescue Approach) | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. | The analysis population included all randomized participants who received at least one dose of investigational product. | Posted | | Number | | Percentage of Participants | | Up to 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG002 | Placebo | |
|
| Primary | Percentage of Participants Discontinuing Study Treatment Due to an AE (Including Rescue Approach) (China Subpopulation) | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. | The analysis population included all randomized participants in China who received at least one dose of investigational product. | Posted | | Number | | Percentage of Participants | | Up to 26 weeks | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG002 | Placebo |
|
| Secondary | Change From Baseline in Fasting Plasma Glucose at Week 26 (Excluding Rescue Approach) | Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at Week 0) which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. | The analysis population included all randomized participants who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post-baseline up to Week 26. | Posted | | Least Squares Mean | 95% Confidence Interval | mg/dL | | Baseline and Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. |
|
| Secondary | Change From Baseline in Fasting Plasma Glucose at Week 26 (Excluding Rescue Approach) (China Subpopulation) | Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at Week 0) which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. | The analysis population included all randomized participants in China who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post-baseline up to Week 26. | Posted | | Least Squares Mean | 95% Confidence Interval | mg/dL | | Baseline and Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | |
|
| Secondary | Change From Baseline in Body Weight at Week 26 (Excluding Rescue Approach) | The change in body weight from baseline reflects the Week 26 body weight minus the Week 0 body weight (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. | The analysis population included all randomized participants and who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post-baseline up to Week 26. | Posted | | Least Squares Mean | 95% Confidence Interval | Kilograms | | Baseline and Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. |
|
| Secondary | Change From Baseline in Body Weight at Week 26 (Excluding Rescue Approach) (China Subpopulation) | The change in body weight from baseline reflects the Week 26 body weight minus the Week 0 body weight (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. | The analysis population included all randomized participants in China who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post-baseline up to Week 26. | Posted | | Least Squares Mean | 95% Confidence Interval | Kilograms | | Baseline and Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. |
|
| Secondary | Percentage of Participants With HbA1c of <7.0% (53 mmol/Mol) (Logistic Regression Using Multiple Imputation Based on cLDA Model: Excluding Rescue Approach) | A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. | The analysis population included all randomized participants who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post baseline up to Week 26. | Posted | | Number | | Percentage of participants | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. |
|
| Secondary | Percentage of Participants With HbA1c of <7.0% (53 mmol/Mol) (Logistic Regression Using Multiple Imputation Based on cLDA Model: Excluding Rescue Approach) (China Subpopulation) | A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. | The analysis population included all randomized participants in China who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post baseline up to Week 26. | Posted | | Number | | Percentage of participants | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. |
|
| Secondary | Change From Baseline in Sitting Systolic Blood Pressure at Week 26 (Excluding Rescue Approach) | This change from baseline reflects the Week 26 sitting systolic blood pressure (SBP) minus the Week 0 sitting SBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. | The analysis population included all randomized participants who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post baseline up to Week 26. | Posted | | Least Squares Mean | 95% Confidence Interval | mmHg | | Baseline and Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. |
|
| Secondary | Change From Baseline in Sitting Systolic Blood Pressure at Week 26 (Excluding Rescue Approach) (China Subpopulation) | This change from baseline reflects the Week 26 sitting systolic blood pressure (SBP) minus the Week 0 sitting SBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. | The analysis population included all randomized participants in China who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post baseline up to Week 26. | Posted | | Least Squares Mean | 95% Confidence Interval | mmHg | | Baseline and Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. |
|
| Secondary | Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 (Excluding Rescue Approach) | This change from baseline reflects the Week 26 sitting diastolic blood pressure (DBP) minus the Week 0 sitting DBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. | The analysis population included all randomized participants who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post baseline up to Week 26. | Posted | | Least Squares Mean | 95% Confidence Interval | mmHg | | Baseline and Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. |
|
| Secondary | Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 (Excluding Rescue Approach) (China Subpopulation) | This change from baseline reflects the Week 26 sitting diastolic blood pressure (DBP) minus the Week 0 sitting DBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. | The analysis population included all randomized participants in China who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post baseline up to Week 26. | Posted | | Least Squares Mean | 95% Confidence Interval | mmHg | | Baseline and Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. |
|
| Secondary | Percentage of Participants With HbA1c of <6.5% (48 mmol/Mol) at Week 26 (Logistic Regression Using Multiple Imputation: Excluding Rescue Approach) | A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. | The analysis population included all randomized participants who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post baseline up to Week 26. | Posted | | Number | | Percentage of participants | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. |
|
| Secondary | Percentage of Participants With HbA1c of <6.5% (48 mmol/Mol) at Week 26 (Logistic Regression Using Multiple Imputation: Excluding Rescue Approach) (China Subpopulation) | A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. | The analysis population included all randomized participants in China who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post baseline up to Week 26. | Posted | | Number | | Percentage of participants | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. |
|
| Secondary | Percentage of Participants Requiring Glycemic Rescue Therapy Through Week 26. | Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. | The analysis population included all randomized participants who received at least one dose of investigational product. | Posted | | Number | | Percentage of Participants | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG002 | Placebo | Placebo matching ertugliflozin administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. |
|
| Secondary | Percentage of Participants Requiring Glycemic Rescue Therapy Through Week 26 (China Subpopulation) | Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. | The analysis population included all randomized participants in China who received at least one dose of investigational product. | Posted | | Number | | Percentage of Participants | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG002 | Placebo | Placebo matching ertugliflozin administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. |
|
| Secondary | Time to Glycemic Rescue Therapy | Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. | The analysis population included all randomized participants who received at least one dose of investigational product who received glycemic rescue through Week 26. | Posted | | Median | Full Range | Days | | Up to 183 days | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG002 | Placebo | Placebo matching ertugliflozin administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. |
|
| Secondary | Time to Glycemic Rescue Therapy (China Subpopulation) | Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. | The analysis population included all randomized participants in China who received at least one dose of investigational product and who received glycemic rescue through Week 26. No participants in the Ertugliflozin 5 mg group were rescued. | Posted | | Median | Full Range | Days | | Up to 149 days | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG002 | Placebo | Placebo matching ertugliflozin administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. |
|
| Secondary | Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach | No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. | The analysis population included all randomized participants who received at least one dose of investigational product and who had at least one plasma concentration value above the lower limit of quantification. No ertugliflozin plasma concentrations were determined for participants receiving placebo. | Posted | | Mean | Standard Deviation | ng/mL | | Week 6: Pre-Dose | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG002 | Placebo |
|
| Secondary | Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach | No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. | The analysis population included all randomized participants who received at least one dose of investigational product and who had at least one plasma concentration value above the lower limit of quantification. No ertugliflozin plasma concentrations were determined for participants receiving placebo. | Posted | | Mean | Standard Deviation | ng/mL | | Week 12: Pre-Dose | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG002 | Placebo |
|
| Secondary | Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach | No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. | The analysis population included all randomized participants who received at least one dose of investigational product and who had at least one plasma concentration value above the lower limit of quantification. No ertugliflozin plasma concentrations were determined for participants receiving placebo. | Posted | | Mean | Standard Deviation | ng/mL | | Week 12: 60 min. Post-Dose | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG002 | Placebo |
|
| Secondary | Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach | No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. | The analysis population included all randomized participants who received at least one dose of investigational product and who had at least one plasma concentration value above the lower limit of quantification. No ertugliflozin plasma concentrations were determined for participants receiving placebo. | Posted | | Mean | Standard Deviation | ng/mL | | Week 18: Pre-Dose | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG002 | Placebo |
|
| Secondary | Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach | No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. | The analysis population included all randomized participants who received at least one dose of investigational product and who had at least one plasma concentration value above the lower limit of quantification. No ertugliflozin plasma concentrations were determined for participants receiving placebo. | Posted | | Mean | Standard Deviation | ng/mL | | Week 18: 60 min. Post-Dose | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG002 | Placebo |
|
| Secondary | Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach | No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. | The analysis population included all randomized participants who received at least one dose of investigational product and who had at least one plasma concentration value above the lower limit of quantification. No ertugliflozin plasma concentrations were determined for participants receiving placebo. | Posted | | Mean | Standard Deviation | ng/mL | | Week 26: Pre-Dose | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG002 | Placebo |
|
| Secondary | Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation) | No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. | The analysis population included all randomized participants in China who received at least one dose of investigational product and who had at least one plasma concentration value above the lower limit of quantification. No ertugliflozin plasma concentrations were determined for participants receiving placebo. | Posted | | Mean | Standard Deviation | ng/mL | | Week 6: Pre-Dose | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG002 | Placebo |
|
| Secondary | Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation) | No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. | The analysis population included all randomized participants in China who received at least one dose of investigational product and who had at least one plasma concentration value above the lower limit of quantification. No ertugliflozin plasma concentrations were determined for participants receiving placebo. | Posted | | Mean | Standard Deviation | ng/mL | | Week 12: Pre-Dose | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG002 | Placebo |
|
| Secondary | Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation) | No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. | The analysis population included all randomized participants in China who received at least one dose of investigational product and who had at least one plasma concentration value above the lower limit of quantification. No ertugliflozin plasma concentrations were determined for participants receiving placebo. | Posted | | Mean | Standard Deviation | ng/mL | | Week 12: 60 min. Post-Dose | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG002 | Placebo |
|
| Secondary | Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation) | No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. | The analysis population included all randomized participants in China who received at least one dose of investigational product and who had at least one plasma concentration value above the lower limit of quantification. No ertugliflozin plasma concentrations were determined for participants receiving placebo. | Posted | | Mean | Standard Deviation | ng/mL | | Week 18: Pre-Dose | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG002 | Placebo |
|
| Secondary | Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation) | No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. | The analysis population included all randomized participants in China who received at least one dose of investigational product and who had at least one plasma concentration value above the lower limit of quantification. No ertugliflozin plasma concentrations were determined for participants receiving placebo. | Posted | | Mean | Standard Deviation | ng/mL | | Week 18: 60 min. Post-Dose | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG002 | Placebo |
|
| Secondary | Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation) | No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. | The analysis population included all randomized participants in China who received at least one dose of investigational product and who had at least one plasma concentration value above the lower limit of quantification. No ertugliflozin plasma concentrations were determined for participants receiving placebo. | Posted | | Mean | Standard Deviation | ng/mL | | Week 26: Pre-Dose | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 5 mg | Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG001 | Ertugliflozin 15 mg | Ertugliflozin 15 mg administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. | | OG002 | Placebo |
|