| Primary | Area Under the Plasma Concentration-Time Profile for Ertugliflozin From Time 0 Extrapolated to Infinite Time (AUCinf) | Area under the plasma concentration-time profile from Time 0 extrapolated to infinite time. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. Geometric Coefficient of Variation was reported as a percent. | The analysis population was defined as all treated participants who had at least one concentration measurement for AUCinf. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng•hr/mL | | Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment | | OG003 | Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment | | OG004 | Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0001199± 42
- OG0011908± 28
- OG0022075± 19
- OG003
|
|
| | 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 |
|---|
| | | | | | Ratio (Heathy Normal/T2DM Normal) | 103.07 | | | 2-Sided | 90 | 80.32 | 132.27 | | | The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages. | | Superiority or Other | | | | | |
|
| Primary | Area Under the Plasma Concentration-Time Profile for Ertugliflozin From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) | Area under the plasma concentration-time profile from Time 0 to the time of the last quantifiable concentration (Clast). Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. Geometric Coefficient of Variation was reported as a percent. | The analysis population was defined as all treated participants who had at least one concentration measurement for AUClast. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng•hr/mL | | Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment |
|
| Primary | Apparent Clearance (CL/F) for Plasma Ertugliflozin | CL/F is a calculation of the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes). Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. Geometric Coefficient of Variation was reported as a percent. | The analysis population was defined as all treated participants who had at least one concentration measurement for CL/F. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mL/min | | Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment |
|
| Primary | Maximum Observed Plasma Concentration (Cmax) for Ertugliflozin | Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. Geometric Coefficient of Variation was reported as a percent. | The analysis population was defined as all treated participants who had at least one concentration measurement for Cmax. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment |
|
| Primary | Time for Cmax (Tmax) for Plasma Ertugliflozin | Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose and is observed directly from data as time of first occurrence. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. | The analysis population was defined as all treated participants who had at least one concentration measurement for Tmax. | Posted | | Median | Full Range | Hours | | Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment | |
|
| Primary | Terminal Half-Life (t1/2) for Plasma Ertugliflozin | T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%. T1/2 = Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. | The analysis population was defined as all treated participants who had at least one concentration measurement for t1/2. | Posted | | Mean | Standard Deviation | Hours | | Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment |
|
| Primary | Apparent Volume of Distribution Following Oral Administration (Vz/F) for Plasma Ertugliflozin | VzF is the apparent volume of distribution during terminal phase after oral / extravascular administration. VzF = Dose/(AUCinf × kel) where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. Geometric Coefficient of Variation was reported as a percent. | The analysis population was defined as all treated participants who had at least one concentration measurement for Vz/F. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters | | Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | |
|
| Primary | Unbound Fraction (Fu) for Plasma Ertugliflozin | Fraction of unbound (not protein-bound) drug in plasma. Fu is determined using in vitro equilibrium dialysis method: concentration in buffer at equilibrium/concentration in plasma at equilibrium. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. | The analysis population was defined as all treated participants who had at least one concentration measurement for Fu. | Posted | | Mean | Standard Deviation | Percent of Unbound Drug | | Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment |
|
| Primary | Cumulative Amount of Drug Recovered Unchanged in Urine to 96 Hours Post Dose (Ae96) | Urine samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. Ae96 = Sum of [urine concentration × sample volume] for each collection interval from 0 to 96 hours post dose. Geometric Coefficient of Variation was reported as a percent. | The analysis population was defined as all treated participants who had at least one concentration measurement for Ae96. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Milligrams | | 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, and 72-96 hours after dosing on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment |
|
| Primary | Percent of Dose Recovered Unchanged in Urine From 0 to 96 Hours Postdose (for Ertugliflozin Only) (Ae96%) | Urine samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. Ae96% = Ae96 / Dose × 100 Ae96 = Sum of [urine concentration × sample volume] for each collection interval from 0 to 96 hours post dose. Geometric Coefficient of Variation was reported as a percent. | The analysis population was defined as all treated participants who had at least one concentration measurement for Ae96. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Percent | | 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, and 72-96 hours after dosing on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment |
|
| Primary | Renal Clearance (CLr) for Urinary Ertugliflozin | Urine samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. CLr is Renal Clearance (Ae96 / AUC96), where Ae96 is the cumulative amount of drug recovered unchanged in urine to 96 hours post dose and AUC96 was the area under the concentration-time profile form time 0 to 96 hours. Geometric Coefficient of Variation was reported as a percent. | The analysis population was defined as all treated participants who had at least one concentration measurement for CLr. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mL/min | | 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, and 72-96 hours after dosing on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment |
|
| Primary | Number of Participants Who Experienced an Adverse Event (AE) | An adverse event (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 was defined as all treated participants. | Posted | | Number | | Participants | | Up to 19 days | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment | | OG003 | Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment) |
|
| Primary | Number of Participants Who Discontinued Study Due to an AE | An adverse event (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 was defined as all treated participants. | Posted | | Number | | Participants | | Up to 5 days | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment | | OG003 | Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment) |
|
| Primary | Area Under the Plasma Concentration-Time Profile for Glucuronide Metabolite PF-06481944 From Time 0 Extrapolated to Infinite Time (AUCinf) | Area under the plasma concentration-time profile from Time 0 extrapolated to infinite time. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF 06481944 was determined. Geometric Coefficient of Variation was reported as a percent. | The analysis population was defined as all treated participants who had at least one concentration measurement for AUCinf. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng•hr/mL | | Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment |
|
| Primary | Area Under the Plasma Concentration-Time Profile for Glucuronide Metabolite PF-06481944 From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) | Area under the plasma concentration-time profile from Time 0 to the time of the last quantifiable concentration (Clast). Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF 06481944 was determined. Geometric Coefficient of Variation was reported as a percent. | The analysis population was defined as all treated participants who had at least one concentration measurement for AUClast. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng•hr/mL | | Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | |
|
| Primary | Maximum Observed Plasma Concentration (Cmax) for Glucuronide Metabolite PF-06481944 | Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF 06481944 was determined. Geometric Coefficient of Variation was reported as a percent. | The analysis population was defined as all treated participants who had at least one concentration measurement for Cmax. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment |
|
| Primary | Time for Cmax (Tmax) for Plasma Glucuronide Metabolite PF-06481944 | Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose and is observed directly from data as time of first occurrence. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF 06481944 was determined. | The analysis population was defined as all treated participants who had at least one concentration measurement for Tmax. | Posted | | Median | Full Range | Hours | | Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment |
|
| Primary | Terminal Half-life (t1/2) for Plasma Glucuronide Metabolite PF-06481944 | T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%. T1/2 = Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF 06481944 was determined. | The analysis population was defined as all treated participants who had at least one concentration measurement for t1/2. | Posted | | Mean | Standard Deviation | Hours | | Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment |
|
| Primary | Cumulative Amount of Drug Recovered Unchanged in Urine to 96 Hours Post Dose (Ae96) for Glucuronide Metabolite PF-06481944 | Urine samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. Ae96 = Sum of [urine concentration × sample volume] for each collection interval from 0 to 96 hours post dose. Geometric Coefficient of Variation was reported as a percent. | The analysis population was defined as all treated participants who had at least one concentration measurement for Ae96. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Milligrams | | 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, and 72-96 hours after dosing on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment |
|
| Primary | CLr for Urinary Glucuronide Metabolite PF-06481944 | Urine samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. CLr is Renal Clearance (Ae96 / AUC96), where Ae96 is the cumulative amount of drug recovered unchanged in urine to 96 hours post dose and AUC96 was the area under the concentration-time profile form time 0 to 96 hours. Geometric Coefficient of Variation was reported as a percent. | The analysis population was defined as all treated participants who had at least one concentration measurement for CLr. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mL/min. | | 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, and 72-96 hours after dosing on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment |
|
| Primary | Area Under the Plasma Concentration-Time Profile for Glucuronide Metabolite PF-06685948 From Time 0 Extrapolated to Infinite Time (AUCinf) | Area under the plasma concentration-time profile from Time 0 extrapolated to infinite time. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF-06685948 was determined. Geometric Coefficient of Variation was reported as a percent. | The analysis population was defined as all treated participants who had at least one concentration measurement for AUCinf. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng•hr/mL | | Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment |
|
| Primary | Area Under the Plasma Concentration-Time Profile for Glucuronide Metabolite PF-06685948 From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) | Area under the plasma concentration-time profile from Time 0 to the time of the last quantifiable concentration (Clast). Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF-06685948 was determined. Geometric Coefficient of Variation was reported as a percent. | The analysis population was defined as all treated participants who had at least one concentration measurement for AUClast. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng•hr/mL | | Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | |
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| Primary | Maximum Observed Plasma Concentration (Cmax) for Glucuronide Metabolite PF-06685948 | Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF-06685948 was determined. Geometric Coefficient of Variation was reported as a percent. | The analysis population was defined as all treated participants who had at least one concentration measurement for Cmax. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose | | | | ID | Title | Description |
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| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment |
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| Primary | Time for Cmax (Tmax) for Plasma Glucuronide Metabolite PF-06685948 | Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose and is observed directly from data as time of first occurrence. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF-06685948 was determined. | The analysis population was defined as all treated participants who had at least one concentration measurement for Tmax. | Posted | | Median | Full Range | Hours | | Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose | | | | ID | Title | Description |
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| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment |
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| Primary | Terminal Half-life (t1/2) for Plasma Glucuronide Metabolite PF-06685948 | T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%. T1/2 = Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF-06685948 was determined. | The analysis population was defined as all treated participants who had at least one concentration measurement for t1/2. | Posted | | Mean | Standard Deviation | Hours | | Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose | | | | ID | Title | Description |
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| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment |
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| Primary | Cumulative Amount of Drug Recovered Unchanged in Urine to 96 Hours Post Dose (Ae96) for Glucuronide Metabolite PF-06685948 | Urine samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. Ae96 = Sum of [urine concentration × sample volume] for each collection interval from 0 to 96 hours post dose. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF-06685948 was determined. Geometric Coefficient of Variation was reported as a percent. | The analysis population was defined as all treated participants who had at least one concentration measurement for Ae96. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Milligrams | | 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, and 72-96 hours after dosing on Day 1 | | | | ID | Title | Description |
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| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) |
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| Primary | Renal Clearance (CLr) for Urinary Glucuronide Metabolite PF-06685948 | Urine samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. CLr is Renal Clearance (Ae96 / AUC96), where Ae96 is the cumulative amount of drug recovered unchanged in urine to 96 hours post dose and AUC96 was the area under the concentration-time profile form time 0 to 96 hours. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF-06685948 was determined. Geometric Coefficient of Variation was reported as a percent. | The analysis population was defined as all treated participants who had at least one concentration measurement for CLr. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mL/min | | 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, and 72-96 hours after dosing on Day 1 | | | | ID | Title | Description |
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| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) |
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| Primary | Change From Baseline in 24 Hour Inhibition of Glucose Reabsorption | Inhibition of Glucose Reabsorption = 100 * urinary glucose excretion / (eGFR(ML/MIN) * Weighted Mean Plasma Glucose * 0.0144). 0.0144 is a unit conversion factor used to make the ratio unitless. Geometric Coefficient of Variation was reported as a percent. | The analysis population was defined as all treated participants who had at least one concentration measurement for plasma glucose concentration. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Percentage | | Baseline and 24 Hours | | | | ID | Title | Description |
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| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment | |
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| Primary | Change From Baseline in 24 Hour Fluid Balance | Fluid balance = fluid intake - urine output. | The analysis population was defined as all treated participants who had at least one measurement for fluid balance. | Posted | | Mean | Standard Deviation | Milliliters | | For 24 hours before Baseline (-48 to -24 hours) and up to 24 hours after dosing on Day 1 (Up to 24 hours) | | | | ID | Title | Description |
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| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment | | OG003 | Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment) | |
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| Secondary | Urinary Glucose Excretion Over 24 Hours (UGE0-24hr) for Ertugliflozin | Participants were asked to void at the end of each prescribed interval with forced voids prior to start and at the end of each interval. | The analysis population was defined as all treated participants who had at least one concentration measurement for UGE0-24hr. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Grams | | 0-4, 4-8, 8-12, 12-24 hours after dosing on Day 1 | | | | ID | Title | Description |
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| OG000 | Ertugliflozin 15 mg (T2DM With Normal Renal Function) | Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function | | OG001 | Ertugliflozin 15 mg (T2DM With Mild Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment | | OG002 | Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment) | Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment | | OG003 | Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment) |
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