Adult, Diabetes Mellitus, Type 2
Conditions
Brief summary
This is a Phase 1 randomized, double-blind, sponsor open, 4 arm, 2 way cross-over study using 2 cohorts. The objective of the study is to evaluate the pharmacodynamics (PD) effects and the pharmacokinetic (PK) of single day dosing of 2 mg and 4 mg doses of ertugliflozin (Ertu, PF-04971729/MK-8835) each administered once vs twice daily (morning \[AM\] and evening \[PM\]) in adults with type 2 diabetes.
Interventions
DRUGErtugliflozin 2 mg single dose
Ertugliflozin 2 mg dose (two 1 mg strength tablets), administered as a single dose
DRUGErtugliflozin 2 mg split into twice daily
Ertugliflozin 1 mg dose (1 mg strength tablet) administered twice daily x 1 day
DRUGErtugliflozin 4 mg single dose
Ertugliflozin 4 mg dose (four 1 mg strength tablets), administered as a single dose
DRUGErtugliflozin 4 mg split into twice daily
Ertugliflozin 2 mg dose (two 1 mg strength tablets) administered twice daily x 1 day
DRUGPlacebo
Placebo to ertugliflozin administered as a single dose
Sponsors
Pfizer
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participants with type 2 diabetes mellitus, either treatment-naïve or on up to 2 acceptable oral anti-diabetes drugs for at least 8-weeks prior to study.
Exclusion criteria
* Participants with type 1 diabetes mellitus, participants with stroke, unstable angina, heart attack in last 6-months, uncontrolled blood pressure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Urinary Glucose Excretion Over 0 to 24 Hours | 0 to 24 hours after the morning dose | Urine for analysis of glucose was collected at prespecified intervals. Each participant emptied his/her bladder just before dosing, and the collection started after the morning dose (collection times: 0-4 hours, 4-8 hours, 8-12 hours, and 12-24 hours after the morning dose). The average amount of urinary glucose excreted from 0 to 24 hours after the morning dose is presented in the table below. |
| Urinary Glucose Excretion by Time Period | At 0-4 hrs, 4-8 hrs, 8-12 hrs, and 12-24 hrs after the AM dose (up to 24 hours) | Urine for analysis of glucose was collected at prespecified intervals. Each participant emptied his/her bladder just before dosing, and the collection started after the morning dose (collection times: 0-4 hours, 4-8 hours, 8-12 hours, and 12-24 hours after the morning dose). The average amount of urinary glucose excreted during the pre-specified time frame is presented in the table below. |
| 24-hour Weighted Mean Plasma Glucose | Up to 24 hours | Blood was collected during each treatment period at pre-dose (fasted) on Day 1 (Hour 0) and post-dose (fed) on Day 1 at 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 12.5, 13, 14, 15, 16, 18, and 24 hours. |
| Weighted Mean Postprandial Plasma Glucose | At 0-5 hours, 5-12 hrs, and 12-18 hrs after the morning dose (up to 18 hours) | The weighted mean postprandial glucose over the specified intervals were analyzed by cohort. |
| Fasting Plasma Glucose | Up to 24 hours | Blood samples were to be collected following a fast from all food and drink (except water) for at least 8 hours. Fasting Plasma Glucose was collected as part of the assessment of weighted mean 24-hour plasma glucose. As such, it was not specified as an endpoint in the Statistical Analysis Plan and was not analyzed or summarized separately. |
| Fasting C-peptide | Up to 24 hours (0 and 24 hours) | The fasting c-peptide was analyzed by cohort using a mixed-effects model with sequence, period, and treatment as fixed effects and participant within sequence as a random effect. |
| Number of Participants Experiencing an Adverse Event | Up to 16 days | An adverse event is any untoward medical occurrence in a clinical investigation participant administered a product or medical device. The table below includes all data collected since the first dose of study drug. |
| Number of Participants Discontinuing Study Drug Due to an Adverse Event | Up to 8 days (Day 1 in each dosing period) | An adverse event is any untoward medical occurrence in a clinical investigation participant administered a product or medical device. The table below includes all data collected since the first dose of study drug. Data include participants discontinued due to adverse events, participants with dose reduced or temporary discontinuation due to adverse events. |
| Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUClast) for Ertugliflozin | 0 predose, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 18, 24 hours postdose | Pharmacokinetic (PK) parameter of AUClast for study drug. Actual sample collection times (relative to the AM dose) were used for the pharmacokinetic analysis. |
| Maximum Plasma Concentration (Cmax) of Ertugliflozin | 0 predose, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 18, 24 hours postdose | PK parameter of Cmax for study drug. Actual sample collection times (relative to the AM dose) were used for the pharmacokinetic analysis. |
| Time Taken to Reach the Maximum Observed Plasma Concentration (Tmax) of Ertugliflozin | 0 predose, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 18, 24 hours postdose | PK parameter of Tmax for study drug. Actual sample collection times (relative to the AM dose) were used for the pharmacokinetic analysis. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 Period 1: participants received a total daily dose of ertugliflozin 2 mg for 1 day; Period 2: participants received a total daily dose of ertugliflozin 2 mg for 1 day | 26 |
| Cohort 2 Period 1: participants received a total daily dose of ertugliflozin 4 mg; Period 2: participants received a total daily dose of ertugliflozin 4 mg for 1 day | 26 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Period 1 | Adverse Event | 1 | 0 | 0 | 0 |
| Period 2 | Withdrawal by Subject | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Age, Customized 18 - 44 years | 7 Participants | 7 Participants | 14 Participants |
| Age, Customized 45 - 64 years | 17 Participants | 18 Participants | 35 Participants |
| Age, Customized 65 years or older | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 22 Participants | 23 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 26 | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 5 / 25 | 8 / 26 | 3 / 26 | 5 / 26 |
| serious Total, serious adverse events | 0 / 25 | 0 / 26 | 0 / 26 | 0 / 26 |
Outcome results
Primary
24-hour Weighted Mean Plasma Glucose
Blood was collected during each treatment period at pre-dose (fasted) on Day 1 (Hour 0) and post-dose (fed) on Day 1 at 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 12.5, 13, 14, 15, 16, 18, and 24 hours.
Time frame: Up to 24 hours
Population: Analysis population included randomized participants who received study drug and had mean plasma glucose measurements during all of the specific collection time frames.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Ertugliflozin 1 mg Twice Daily | 24-hour Weighted Mean Plasma Glucose | 173.6 mg/dL | Standard Deviation 26.94 |
| Cohort 1: Ertugliflozin 2 mg Once Daily | 24-hour Weighted Mean Plasma Glucose | 175.7 mg/dL | Standard Deviation 29.88 |
| Cohort 2: Ertugliflozin 2 mg Twice Daily | 24-hour Weighted Mean Plasma Glucose | 169.1 mg/dL | Standard Deviation 35.91 |
| Cohort 2: Ertugliflozin 4 mg Once Daily | 24-hour Weighted Mean Plasma Glucose | 170.4 mg/dL | Standard Deviation 41.26 |
Primary
Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUClast) for Ertugliflozin
Pharmacokinetic (PK) parameter of AUClast for study drug. Actual sample collection times (relative to the AM dose) were used for the pharmacokinetic analysis.
Time frame: 0 predose, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 18, 24 hours postdose
Population: All participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Ertugliflozin 1 mg Twice Daily | Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUClast) for Ertugliflozin | 131.8 ng*hr/mL | Geometric Coefficient of Variation 26 |
| Cohort 1: Ertugliflozin 2 mg Once Daily | Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUClast) for Ertugliflozin | 132.7 ng*hr/mL | Geometric Coefficient of Variation 28 |
| Cohort 2: Ertugliflozin 2 mg Twice Daily | Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUClast) for Ertugliflozin | 272 ng*hr/mL | Geometric Coefficient of Variation 19 |
| Cohort 2: Ertugliflozin 4 mg Once Daily | Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUClast) for Ertugliflozin | 270.5 ng*hr/mL | Geometric Coefficient of Variation 20 |
Primary
Cumulative Urinary Glucose Excretion Over 0 to 24 Hours
Urine for analysis of glucose was collected at prespecified intervals. Each participant emptied his/her bladder just before dosing, and the collection started after the morning dose (collection times: 0-4 hours, 4-8 hours, 8-12 hours, and 12-24 hours after the morning dose). The average amount of urinary glucose excreted from 0 to 24 hours after the morning dose is presented in the table below.
Time frame: 0 to 24 hours after the morning dose
Population: Analysis population included randomized participants who received assigned dose and had urine collection during all of the collection time frames between 0 and 24 hours following the morning dose.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Ertugliflozin 1 mg Twice Daily | Cumulative Urinary Glucose Excretion Over 0 to 24 Hours | 69.45 Grams | 90% Confidence Interval 9.08 |
| Cohort 1: Ertugliflozin 2 mg Once Daily | Cumulative Urinary Glucose Excretion Over 0 to 24 Hours | 70.43 Grams | 90% Confidence Interval 9.08 |
| Cohort 2: Ertugliflozin 2 mg Twice Daily | Cumulative Urinary Glucose Excretion Over 0 to 24 Hours | 78.29 Grams | 90% Confidence Interval 9.77 |
| Cohort 2: Ertugliflozin 4 mg Once Daily | Cumulative Urinary Glucose Excretion Over 0 to 24 Hours | 80.54 Grams | 90% Confidence Interval 9.81 |
Primary
Fasting C-peptide
The fasting c-peptide was analyzed by cohort using a mixed-effects model with sequence, period, and treatment as fixed effects and participant within sequence as a random effect.
Time frame: Up to 24 hours (0 and 24 hours)
Population: Analysis population included randomized participants who received assigned dose and had fasting c-peptide measurements during the specific time frame.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Ertugliflozin 1 mg Twice Daily | Fasting C-peptide | 2.82 ng/mL | 90% Confidence Interval 1.148 |
| Cohort 1: Ertugliflozin 2 mg Once Daily | Fasting C-peptide | 2.76 ng/mL | 90% Confidence Interval 0.997 |
| Cohort 2: Ertugliflozin 2 mg Twice Daily | Fasting C-peptide | 3.00 ng/mL | 90% Confidence Interval 0.916 |
| Cohort 2: Ertugliflozin 4 mg Once Daily | Fasting C-peptide | 2.99 ng/mL | 90% Confidence Interval 0.973 |
Primary
Fasting Plasma Glucose
Blood samples were to be collected following a fast from all food and drink (except water) for at least 8 hours. Fasting Plasma Glucose was collected as part of the assessment of weighted mean 24-hour plasma glucose. As such, it was not specified as an endpoint in the Statistical Analysis Plan and was not analyzed or summarized separately.
Time frame: Up to 24 hours
Population: The protocol listed fasting plasma glucose as one of the endpoints of the study. However, given the assessment of weighted mean 24-hour plasma glucose and weighted mean postprandial glucose following the 3 meals on Day 1 of each period, analysis of fasting plasma glucose was not undertaken.
Primary
Maximum Plasma Concentration (Cmax) of Ertugliflozin
PK parameter of Cmax for study drug. Actual sample collection times (relative to the AM dose) were used for the pharmacokinetic analysis.
Time frame: 0 predose, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 18, 24 hours postdose
Population: All participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Ertugliflozin 1 mg Twice Daily | Maximum Plasma Concentration (Cmax) of Ertugliflozin | 19.51 ng/mL | Geometric Coefficient of Variation 39 |
| Cohort 1: Ertugliflozin 2 mg Once Daily | Maximum Plasma Concentration (Cmax) of Ertugliflozin | 26.98 ng/mL | Geometric Coefficient of Variation 37 |
| Cohort 2: Ertugliflozin 2 mg Twice Daily | Maximum Plasma Concentration (Cmax) of Ertugliflozin | 34.80 ng/mL | Geometric Coefficient of Variation 23 |
| Cohort 2: Ertugliflozin 4 mg Once Daily | Maximum Plasma Concentration (Cmax) of Ertugliflozin | 50.83 ng/mL | Geometric Coefficient of Variation 25 |
Primary
Number of Participants Discontinuing Study Drug Due to an Adverse Event
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a product or medical device. The table below includes all data collected since the first dose of study drug. Data include participants discontinued due to adverse events, participants with dose reduced or temporary discontinuation due to adverse events.
Time frame: Up to 8 days (Day 1 in each dosing period)
Population: Analysis population includes all treated participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Ertugliflozin 1 mg Twice Daily | Number of Participants Discontinuing Study Drug Due to an Adverse Event | 0 Participants |
| Cohort 1: Ertugliflozin 2 mg Once Daily | Number of Participants Discontinuing Study Drug Due to an Adverse Event | 1 Participants |
| Cohort 2: Ertugliflozin 2 mg Twice Daily | Number of Participants Discontinuing Study Drug Due to an Adverse Event | 0 Participants |
| Cohort 2: Ertugliflozin 4 mg Once Daily | Number of Participants Discontinuing Study Drug Due to an Adverse Event | 0 Participants |
Primary
Number of Participants Experiencing an Adverse Event
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a product or medical device. The table below includes all data collected since the first dose of study drug.
Time frame: Up to 16 days
Population: Analysis population includes all treated participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Ertugliflozin 1 mg Twice Daily | Number of Participants Experiencing an Adverse Event | 5 Participants |
| Cohort 1: Ertugliflozin 2 mg Once Daily | Number of Participants Experiencing an Adverse Event | 8 Participants |
| Cohort 2: Ertugliflozin 2 mg Twice Daily | Number of Participants Experiencing an Adverse Event | 3 Participants |
| Cohort 2: Ertugliflozin 4 mg Once Daily | Number of Participants Experiencing an Adverse Event | 5 Participants |
Primary
Time Taken to Reach the Maximum Observed Plasma Concentration (Tmax) of Ertugliflozin
PK parameter of Tmax for study drug. Actual sample collection times (relative to the AM dose) were used for the pharmacokinetic analysis.
Time frame: 0 predose, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 18, 24 hours postdose
Population: All participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Ertugliflozin 1 mg Twice Daily | Time Taken to Reach the Maximum Observed Plasma Concentration (Tmax) of Ertugliflozin | 6.00 hours |
| Cohort 1: Ertugliflozin 2 mg Once Daily | Time Taken to Reach the Maximum Observed Plasma Concentration (Tmax) of Ertugliflozin | 1.00 hours |
| Cohort 2: Ertugliflozin 2 mg Twice Daily | Time Taken to Reach the Maximum Observed Plasma Concentration (Tmax) of Ertugliflozin | 6.00 hours |
| Cohort 2: Ertugliflozin 4 mg Once Daily | Time Taken to Reach the Maximum Observed Plasma Concentration (Tmax) of Ertugliflozin | 1.00 hours |
Primary
Urinary Glucose Excretion by Time Period
Urine for analysis of glucose was collected at prespecified intervals. Each participant emptied his/her bladder just before dosing, and the collection started after the morning dose (collection times: 0-4 hours, 4-8 hours, 8-12 hours, and 12-24 hours after the morning dose). The average amount of urinary glucose excreted during the pre-specified time frame is presented in the table below.
Time frame: At 0-4 hrs, 4-8 hrs, 8-12 hrs, and 12-24 hrs after the AM dose (up to 24 hours)
Population: Analysis population included randomized participants who received assigned dose and had urine collection during the specific time frame.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Ertugliflozin 1 mg Twice Daily | Urinary Glucose Excretion by Time Period | 0 to 4 hours post dose | 12.88 Grams | Standard Deviation 14.66 |
| Cohort 1: Ertugliflozin 1 mg Twice Daily | Urinary Glucose Excretion by Time Period | 4 to 8 hours post dose | 15.42 Grams | Standard Deviation 12 |
| Cohort 1: Ertugliflozin 1 mg Twice Daily | Urinary Glucose Excretion by Time Period | 8 to 12 hours post dose | 14.47 Grams | Standard Deviation 8.84 |
| Cohort 1: Ertugliflozin 1 mg Twice Daily | Urinary Glucose Excretion by Time Period | 12 to 24 hours post dose | 26.76 Grams | Standard Deviation 20.1 |
| Cohort 1: Ertugliflozin 2 mg Once Daily | Urinary Glucose Excretion by Time Period | 4 to 8 hours post dose | 17.87 Grams | Standard Deviation 12.6 |
| Cohort 1: Ertugliflozin 2 mg Once Daily | Urinary Glucose Excretion by Time Period | 8 to 12 hours post dose | 11.99 Grams | Standard Deviation 7.7 |
| Cohort 1: Ertugliflozin 2 mg Once Daily | Urinary Glucose Excretion by Time Period | 12 to 24 hours post dose | 26.31 Grams | Standard Deviation 21.11 |
| Cohort 1: Ertugliflozin 2 mg Once Daily | Urinary Glucose Excretion by Time Period | 0 to 4 hours post dose | 14.03 Grams | Standard Deviation 11.63 |
| Cohort 2: Ertugliflozin 2 mg Twice Daily | Urinary Glucose Excretion by Time Period | 8 to 12 hours post dose | 14.30 Grams | Standard Deviation 10.52 |
| Cohort 2: Ertugliflozin 2 mg Twice Daily | Urinary Glucose Excretion by Time Period | 4 to 8 hours post dose | 16.97 Grams | Standard Deviation 11.64 |
| Cohort 2: Ertugliflozin 2 mg Twice Daily | Urinary Glucose Excretion by Time Period | 12 to 24 hours post dose | 31.47 Grams | Standard Deviation 22.71 |
| Cohort 2: Ertugliflozin 2 mg Twice Daily | Urinary Glucose Excretion by Time Period | 0 to 4 hours post dose | 14.66 Grams | Standard Deviation 11.81 |
| Cohort 2: Ertugliflozin 4 mg Once Daily | Urinary Glucose Excretion by Time Period | 12 to 24 hours post dose | 32.94 Grams | Standard Deviation 21.08 |
| Cohort 2: Ertugliflozin 4 mg Once Daily | Urinary Glucose Excretion by Time Period | 4 to 8 hours post dose | 19.78 Grams | Standard Deviation 14.02 |
| Cohort 2: Ertugliflozin 4 mg Once Daily | Urinary Glucose Excretion by Time Period | 0 to 4 hours post dose | 16.34 Grams | Standard Deviation 10.16 |
| Cohort 2: Ertugliflozin 4 mg Once Daily | Urinary Glucose Excretion by Time Period | 8 to 12 hours post dose | 12.91 Grams | Standard Deviation 6.93 |
Primary
Weighted Mean Postprandial Plasma Glucose
The weighted mean postprandial glucose over the specified intervals were analyzed by cohort.
Time frame: At 0-5 hours, 5-12 hrs, and 12-18 hrs after the morning dose (up to 18 hours)
Population: Analysis population included randomized participants who received assigned dose and had postprandial plasma glucose measurements during the specific time frame.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Ertugliflozin 1 mg Twice Daily | Weighted Mean Postprandial Plasma Glucose | 0 to 5 hours | 200.1 mg/dL | Standard Deviation 38.27 |
| Cohort 1: Ertugliflozin 1 mg Twice Daily | Weighted Mean Postprandial Plasma Glucose | 12 to 18 hours | 180.7 mg/dL | Standard Deviation 35.98 |
| Cohort 1: Ertugliflozin 1 mg Twice Daily | Weighted Mean Postprandial Plasma Glucose | 5 to 12 hours | 159.4 mg/dL | Standard Deviation 25.76 |
| Cohort 1: Ertugliflozin 2 mg Once Daily | Weighted Mean Postprandial Plasma Glucose | 0 to 5 hours | 187.2 mg/dL | Standard Deviation 41.37 |
| Cohort 1: Ertugliflozin 2 mg Once Daily | Weighted Mean Postprandial Plasma Glucose | 12 to 18 hours | 190.7 mg/dL | Standard Deviation 35.38 |
| Cohort 1: Ertugliflozin 2 mg Once Daily | Weighted Mean Postprandial Plasma Glucose | 5 to 12 hours | 159.8 mg/dL | Standard Deviation 28.46 |
| Cohort 2: Ertugliflozin 2 mg Twice Daily | Weighted Mean Postprandial Plasma Glucose | 5 to 12 hours | 160.5 mg/dL | Standard Deviation 42.14 |
| Cohort 2: Ertugliflozin 2 mg Twice Daily | Weighted Mean Postprandial Plasma Glucose | 0 to 5 hours | 194.1 mg/dL | Standard Deviation 46.87 |
| Cohort 2: Ertugliflozin 2 mg Twice Daily | Weighted Mean Postprandial Plasma Glucose | 12 to 18 hours | 182.6 mg/dL | Standard Deviation 40.79 |
| Cohort 2: Ertugliflozin 4 mg Once Daily | Weighted Mean Postprandial Plasma Glucose | 0 to 5 hours | 189.9 mg/dL | Standard Deviation 53.17 |
| Cohort 2: Ertugliflozin 4 mg Once Daily | Weighted Mean Postprandial Plasma Glucose | 12 to 18 hours | 181.9 mg/dL | Standard Deviation 40.79 |
| Cohort 2: Ertugliflozin 4 mg Once Daily | Weighted Mean Postprandial Plasma Glucose | 5 to 12 hours | 161.5 mg/dL | Standard Deviation 40.7 |