Diabetes Mellitus, Type 2, Hypertension
Conditions
Keywords
type 2 diabetes, hypertension, ambulatory blood pressure monitoring
Brief summary
MK-8835-042 (B1521004) is designed to assess the safety and efficacy of an investigational drug, ertugliflozin (MK-8835, PF-04971729), in participants with type 2 diabetes and hypertension. Participants in the study will receive 1 of 5 treatments for 28 days (either placebo, 1 of 3 doses of ertugliflozin \[1, 5, or 25 mg\], or the approved drug hydrochlorothiazide \[HCTZ\]). The primary hypothesis of the study was that ertugliflozin was superior to placebo on the change from baseline in average, 24-hour systolic blood pressure (SBP) on Day 28.
Interventions
DRUGPlacebo to Ertuglilflozin 1 or 5 mg
Placebo to ertuglilflozin tablet 1 or 5 mg once daily for 28 days
Ertugliflozin tablet 1 mg once daily for 28 days
Ertugliflozin tablet 5 mg once daily for 28 days
Ertugliflozin tablet 25 mg once daily for 28 days
DRUGHCTZ 12.5mg
Hydrocholorthiazide (HCTZ) 12.5 mg capsule once daily for 28 days
DRUGPlacebo to HCTZ
Placebo to HCTZ 12.5 mg capsule once daily for 28 days
DRUGPlacebo to ertuglilflozin 25 mg
Placebo to ertuglilflozin tablet 25 mg once daily for 28 days
Sponsors
Pfizer
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participants with type 2 diabetes and hypertension * Medically stable * On at least 1 (and up to 2) oral diabetes drugs * And up to 2 medicines for blood pressure control
Exclusion criteria
* Participants with type 1 diabetes * Heart attack * Stroke * Uncontrolled blood pressure * Significant kidney disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline 24-hour Average Systolic Blood Pressure (SBP) | 24 hours | Baseline 24-hour average SBP was assessed using 24-hour ambulatory blood pressure monitoring (ABPM). |
| Change From Baseline on 24-hour Average SBP at Week 4 | Baseline and Week 4 | Change from baseline on 24-hour average SBP at Week 4 assessed using 24-hour ABPM. In the case of missing data, last observation carried forward (LOCF). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Average Daytime and Nighttime SBP | Daytime: 16 hours; Nighttime: 8 hours | Daytime was defined as 0600 to 2159 hours, inclusive, local time. Nighttime was defined as 2200 to 0559 hours, inclusive, local time. |
| Change From Baseline on Daytime Average SBP at Week 4 | Baseline and Week 4 | Change from baseline on daytime average SBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Daytime was defined as 0600 to 2159 hours, inclusive, local time. |
| Change From Baseline on Nighttime Average SBP at Week 4 | Baseline and Week 4 | Change from baseline on nighttime average SBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Nighttime was defined as 2200 to 0559 hours, inclusive, local time. |
| Baseline Seated, Triplicate Trough SBP | Baseline | Trough SBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. Baseline trough SBP is calculated as the mean of triplicate (3) trough SBP measures. |
| Change From Baseline in Seated, Triplicate Trough SBP at Week 4 | Baseline and Week 4 | Trough SBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. The change from baseline at Week 4 is the difference between the baseline and Week 4 assessments. |
| Baseline 24-hour, Daytime and Nightime Average Diastolic Blood Pressure (DBP) | up to 24 hours | Baseline 24-hour average DBP was assessed using 24-hour ABPM. Daytime was defined as 0600 to 2159 hours, inclusive, local time. Nighttime was defined as 2200 to 0559 hours, inclusive, local time. |
| Change From Baseline on 24-hour Average DBP at Week 4 | Baseline and Week 4 | Change from baseline on 24-hour average DBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. |
| Change From Baseline on Daytime Average DBP at Week 4 | Baseline and Week 4 | Change from baseline on daytime average DBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Daytime was defined as 0600 to 2159 hours, inclusive, local time. |
| Change From Baseline on Nighttime Average DBP at Week 4 | Baseline and Week 4 | Change from baseline on nighttime average DBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Nighttime was defined as 2200 to 0559 hours, inclusive, local time. |
| Baseline Seated, Triplicate Trough DBP | Baseline | Trough DBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. Baseline trough DBP is calculated as the mean of triplicate (3) trough DBP measures. |
| Change From Baseline in Seated, Triplicate Trough DBP at Week 4 | Baseline and Week 4 | Trough DBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. The change from baseline at Week 4 is the difference between the baseline and Week 4 assessments. |
| Baseline 24-hour, Daytime and Nightime Average Heart Rate | up to 24 hours | Baseline 24-hour average heart rate was assessed using 24-hour ABPM. Daytime was defined as 0600 to 2159 hours, inclusive, local time. Nighttime was defined as 2200 to 0559 hours, inclusive, local time. |
| Change From Baseline on 24-hour Average Heart Rate at Week 4 | Baseline and Week 4 | Change from baseline in 24-hour average heart rate at Week 4 using 24 hour ABPM. |
| Change From Baseline on Daytime Average Heart Rate at Week 4 | Baseline and Week 4 | Change from baseline in daytime average heart rate at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Daytime was defined as 0600 to 2159 hours, inclusive, local time. |
| Change From Baseline on Nighttime Average Heart Rate at Week 4 | Baseline and Week 4 | Change from baseline in 24-hour nighttime average heart rate at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Nighttime was defined as 2200 to 0559 hours, inclusive, local time. |
| Baseline Seated, Triplicate Trough Heart Rate | Baseline | Trough heart rate was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the heart rate measure was obtained. Three measurements of heart rate were taken at least 2-minutes apart. Baseline trough heart rate is calculated as the mean of triplicate (3) trough heart rate measures. |
| Change From Baseline in Seated, Triplicate Trough Heart Rate at Week 4 | Baseline and Week 4 | Trough heart rate was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the heart rate measure was obtained. Three measurements of heart rate were taken at least 2-minutes apart. The change from baseline at Week 4 is the difference between the baseline and Week 4 assessments. |
| Baseline 24-hour Average Urinary Glucose Excretion | 24 hours | Urinary glucose excetion was corrected for a duration of 24 hours (with appropriate duration of collection defined as \>20 hours and \<28 hours). |
| Change From Baseline on 24-hour Urinary Glucose Excretion at Week 4 | Baseline and Week 4 | Urinary glucose excetion was corrected for a duration of 24 hours (with appropriate duration of collection defined as \>20 hours and \<28 hours). In the case of missing data, LOCF. |
| Baseline Fasting Plasma Glucose (FPG) | Baseline | For FPG, blood was drawn after an overnight fast of at least 8 hours (except water). |
| Change From Baseline in FPG at Week 4 | Baseline and Week 4 | For FPG, blood was drawn after an overnight fast of at least 8 hours (except water). |
| Change From Baseline in FPG at Week 2 | Baseline and Week 2 | For FPG, blood was drawn after an overnight fast of at least 8 hours (except water). |
| Number of Participants Who Experienced an Adverse Event (AE) | Up to 63 days (including run-in, treatment period, and follow-up) | An adverse event is defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. The table below includes all data collected since first dose of study drug. |
| Number of Participants Who Discontinued Study Drug Due to an AE | Up to 28 days (treatment period) | An adverse event is defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. The table below includes all data collected since first dose of study drug. Discontinuation of study drug due to an AE includes temporary and permanent discontinuation of study drug due to an AE. |
Participant flow
Pre-assignment details
Prior to randomization, 194 participants received placebo for at least 3 weeks (completed the run-in period). Treated participants included all randomized participants who received at least one dose of study drug.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days. | 38 |
| Ertugliflozin 1 mg Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days | 39 |
| Ertugliflozin 5 mg Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days | 38 |
| Ertugliflozin 25 mg Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days | 39 |
| HCTZ 12.5mg HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days | 39 |
| Total | 193 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 1 | 0 | 0 |
| Overall Study | Not treated | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Reason not available | 0 | 1 | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Ertugliflozin 1 mg | Ertugliflozin 5 mg | Ertugliflozin 25 mg | HCTZ 12.5mg | Total |
|---|---|---|---|---|---|---|
| Age, Customized <18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 65 years and older | 1 Participants | 1 Participants | 3 Participants | 0 Participants | 4 Participants | 9 Participants |
| Age, Customized Between 18 and 44 years | 3 Participants | 4 Participants | 3 Participants | 5 Participants | 1 Participants | 16 Participants |
| Age, Customized Between 45 and 64 years | 34 Participants | 34 Participants | 32 Participants | 34 Participants | 34 Participants | 168 Participants |
| Sex: Female, Male Female | 14 Participants | 12 Participants | 13 Participants | 12 Participants | 11 Participants | 62 Participants |
| Sex: Female, Male Male | 24 Participants | 27 Participants | 25 Participants | 27 Participants | 28 Participants | 131 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 38 | 4 / 39 | 8 / 38 | 6 / 39 | 6 / 39 | 10 / 193 |
| serious Total, serious adverse events | 1 / 38 | 0 / 39 | 0 / 38 | 0 / 39 | 0 / 39 | 1 / 194 |
Outcome results
Primary
Baseline 24-hour Average Systolic Blood Pressure (SBP)
Baseline 24-hour average SBP was assessed using 24-hour ambulatory blood pressure monitoring (ABPM).
Time frame: 24 hours
Population: All randomized participants who received at least one dose of study drug and had a baseline measurement for average 24-hour SBP.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Baseline 24-hour Average Systolic Blood Pressure (SBP) | 136.11 mmHg | Standard Deviation 15.298 |
| Ertugliflozin 1 mg | Baseline 24-hour Average Systolic Blood Pressure (SBP) | 133.13 mmHg | Standard Deviation 10.868 |
| Ertugliflozin 5 mg | Baseline 24-hour Average Systolic Blood Pressure (SBP) | 135.08 mmHg | Standard Deviation 12.073 |
| Ertugliflozin 25 mg | Baseline 24-hour Average Systolic Blood Pressure (SBP) | 135.59 mmHg | Standard Deviation 11.929 |
| HCTZ 12.5mg | Baseline 24-hour Average Systolic Blood Pressure (SBP) | 139.55 mmHg | Standard Deviation 11.941 |
Primary
Change From Baseline on 24-hour Average SBP at Week 4
Change from baseline on 24-hour average SBP at Week 4 assessed using 24-hour ABPM. In the case of missing data, last observation carried forward (LOCF).
Time frame: Baseline and Week 4
Population: Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline on 24-hour Average SBP at Week 4 | 0.26 mmHg |
| Ertugliflozin 1 mg | Change From Baseline on 24-hour Average SBP at Week 4 | -2.71 mmHg |
| Ertugliflozin 5 mg | Change From Baseline on 24-hour Average SBP at Week 4 | -3.73 mmHg |
| Ertugliflozin 25 mg | Change From Baseline on 24-hour Average SBP at Week 4 | -3.42 mmHg |
| HCTZ 12.5mg | Change From Baseline on 24-hour Average SBP at Week 4 | -2.95 mmHg |
p-value: 0.03480% CI: [-5.05, -0.89]ANCOVA
p-value: 0.0180% CI: [-6.17, -1.82]ANCOVA
p-value: 0.01280% CI: [-5.78, -1.6]ANCOVA
p-value: 0.02480% CI: [-5.3, -1.13]ANCOVA
Secondary
Baseline 24-hour Average Urinary Glucose Excretion
Urinary glucose excetion was corrected for a duration of 24 hours (with appropriate duration of collection defined as \>20 hours and \<28 hours).
Time frame: 24 hours
Population: All randomized participants who received at least one dose of study drug and had a baseline measurement for average urinary glucose excretion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Baseline 24-hour Average Urinary Glucose Excretion | 13.35 grams/day | Standard Deviation 22.913 |
| Ertugliflozin 1 mg | Baseline 24-hour Average Urinary Glucose Excretion | 9.97 grams/day | Standard Deviation 20.085 |
| Ertugliflozin 5 mg | Baseline 24-hour Average Urinary Glucose Excretion | 8.04 grams/day | Standard Deviation 13.135 |
| Ertugliflozin 25 mg | Baseline 24-hour Average Urinary Glucose Excretion | 17.56 grams/day | Standard Deviation 29.101 |
| HCTZ 12.5mg | Baseline 24-hour Average Urinary Glucose Excretion | 6.96 grams/day | Standard Deviation 8.562 |
Secondary
Baseline 24-hour, Daytime and Nightime Average Diastolic Blood Pressure (DBP)
Baseline 24-hour average DBP was assessed using 24-hour ABPM. Daytime was defined as 0600 to 2159 hours, inclusive, local time. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.
Time frame: up to 24 hours
Population: All randomized participants who received at least one dose of study drug and had a baseline measurement for average 24-hour, daytime and nighttime DBP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Baseline 24-hour, Daytime and Nightime Average Diastolic Blood Pressure (DBP) | Daytime | 85.32 mmHg | Standard Deviation 10.127 |
| Placebo | Baseline 24-hour, Daytime and Nightime Average Diastolic Blood Pressure (DBP) | 24-hr | 81.89 mmHg | Standard Deviation 9.655 |
| Placebo | Baseline 24-hour, Daytime and Nightime Average Diastolic Blood Pressure (DBP) | Nighttime | 74.24 mmHg | Standard Deviation 9.717 |
| Ertugliflozin 1 mg | Baseline 24-hour, Daytime and Nightime Average Diastolic Blood Pressure (DBP) | Daytime | 81.77 mmHg | Standard Deviation 8.925 |
| Ertugliflozin 1 mg | Baseline 24-hour, Daytime and Nightime Average Diastolic Blood Pressure (DBP) | 24-hr | 78.67 mmHg | Standard Deviation 8.6 |
| Ertugliflozin 1 mg | Baseline 24-hour, Daytime and Nightime Average Diastolic Blood Pressure (DBP) | Nighttime | 72.05 mmHg | Standard Deviation 9.33 |
| Ertugliflozin 5 mg | Baseline 24-hour, Daytime and Nightime Average Diastolic Blood Pressure (DBP) | Nighttime | 73.05 mmHg | Standard Deviation 9.034 |
| Ertugliflozin 5 mg | Baseline 24-hour, Daytime and Nightime Average Diastolic Blood Pressure (DBP) | 24-hr | 80.18 mmHg | Standard Deviation 8.655 |
| Ertugliflozin 5 mg | Baseline 24-hour, Daytime and Nightime Average Diastolic Blood Pressure (DBP) | Daytime | 83.47 mmHg | Standard Deviation 9.164 |
| Ertugliflozin 25 mg | Baseline 24-hour, Daytime and Nightime Average Diastolic Blood Pressure (DBP) | Daytime | 83.59 mmHg | Standard Deviation 9.295 |
| Ertugliflozin 25 mg | Baseline 24-hour, Daytime and Nightime Average Diastolic Blood Pressure (DBP) | 24-hr | 80.36 mmHg | Standard Deviation 8.65 |
| Ertugliflozin 25 mg | Baseline 24-hour, Daytime and Nightime Average Diastolic Blood Pressure (DBP) | Nighttime | 73.28 mmHg | Standard Deviation 8.76 |
| HCTZ 12.5mg | Baseline 24-hour, Daytime and Nightime Average Diastolic Blood Pressure (DBP) | Daytime | 85.87 mmHg | Standard Deviation 9.884 |
| HCTZ 12.5mg | Baseline 24-hour, Daytime and Nightime Average Diastolic Blood Pressure (DBP) | 24-hr | 82.66 mmHg | Standard Deviation 9.459 |
| HCTZ 12.5mg | Baseline 24-hour, Daytime and Nightime Average Diastolic Blood Pressure (DBP) | Nighttime | 75.76 mmHg | Standard Deviation 10.042 |
Secondary
Baseline 24-hour, Daytime and Nightime Average Heart Rate
Baseline 24-hour average heart rate was assessed using 24-hour ABPM. Daytime was defined as 0600 to 2159 hours, inclusive, local time. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.
Time frame: up to 24 hours
Population: All randomized participants who received at least one dose of study drug and had a baseline measurement for average 24-hour, daytime and nighttime heart rate.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Baseline 24-hour, Daytime and Nightime Average Heart Rate | Daytime | 84.43 beats per minute | Standard Deviation 9.743 |
| Placebo | Baseline 24-hour, Daytime and Nightime Average Heart Rate | 24-hr | 81.11 beats per minute | Standard Deviation 9.486 |
| Placebo | Baseline 24-hour, Daytime and Nightime Average Heart Rate | Nighttime | 74.05 beats per minute | Standard Deviation 9.871 |
| Ertugliflozin 1 mg | Baseline 24-hour, Daytime and Nightime Average Heart Rate | Nighttime | 74.44 beats per minute | Standard Deviation 8.133 |
| Ertugliflozin 1 mg | Baseline 24-hour, Daytime and Nightime Average Heart Rate | 24-hr | 80.74 beats per minute | Standard Deviation 6.95 |
| Ertugliflozin 1 mg | Baseline 24-hour, Daytime and Nightime Average Heart Rate | Daytime | 83.74 beats per minute | Standard Deviation 7.044 |
| Ertugliflozin 5 mg | Baseline 24-hour, Daytime and Nightime Average Heart Rate | 24-hr | 79.68 beats per minute | Standard Deviation 10.081 |
| Ertugliflozin 5 mg | Baseline 24-hour, Daytime and Nightime Average Heart Rate | Nighttime | 73.16 beats per minute | Standard Deviation 10.205 |
| Ertugliflozin 5 mg | Baseline 24-hour, Daytime and Nightime Average Heart Rate | Daytime | 82.71 beats per minute | Standard Deviation 10.405 |
| Ertugliflozin 25 mg | Baseline 24-hour, Daytime and Nightime Average Heart Rate | Daytime | 82.18 beats per minute | Standard Deviation 9.136 |
| Ertugliflozin 25 mg | Baseline 24-hour, Daytime and Nightime Average Heart Rate | Nighttime | 73.49 beats per minute | Standard Deviation 10.034 |
| Ertugliflozin 25 mg | Baseline 24-hour, Daytime and Nightime Average Heart Rate | 24-hr | 79.41 beats per minute | Standard Deviation 9.063 |
| HCTZ 12.5mg | Baseline 24-hour, Daytime and Nightime Average Heart Rate | Nighttime | 73.03 beats per minute | Standard Deviation 9.736 |
| HCTZ 12.5mg | Baseline 24-hour, Daytime and Nightime Average Heart Rate | 24-hr | 79.08 beats per minute | Standard Deviation 9.216 |
| HCTZ 12.5mg | Baseline 24-hour, Daytime and Nightime Average Heart Rate | Daytime | 81.95 beats per minute | Standard Deviation 9.47 |
Secondary
Baseline Average Daytime and Nighttime SBP
Daytime was defined as 0600 to 2159 hours, inclusive, local time. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.
Time frame: Daytime: 16 hours; Nighttime: 8 hours
Population: All randomized participants who received at least one dose of study drug and had a baseline measurement for daytime and nighttime SBP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Baseline Average Daytime and Nighttime SBP | Nighttime | 127.54 mmHg | Standard Deviation 16.858 |
| Placebo | Baseline Average Daytime and Nighttime SBP | Daytime | 139.95 mmHg | Standard Deviation 15.107 |
| Ertugliflozin 1 mg | Baseline Average Daytime and Nighttime SBP | Nighttime | 125.15 mmHg | Standard Deviation 12.18 |
| Ertugliflozin 1 mg | Baseline Average Daytime and Nighttime SBP | Daytime | 136.85 mmHg | Standard Deviation 11.361 |
| Ertugliflozin 5 mg | Baseline Average Daytime and Nighttime SBP | Daytime | 138.89 mmHg | Standard Deviation 11.724 |
| Ertugliflozin 5 mg | Baseline Average Daytime and Nighttime SBP | Nighttime | 126.37 mmHg | Standard Deviation 13.956 |
| Ertugliflozin 25 mg | Baseline Average Daytime and Nighttime SBP | Daytime | 139.56 mmHg | Standard Deviation 12.343 |
| Ertugliflozin 25 mg | Baseline Average Daytime and Nighttime SBP | Nighttime | 127.13 mmHg | Standard Deviation 13.553 |
| HCTZ 12.5mg | Baseline Average Daytime and Nighttime SBP | Nighttime | 131.68 mmHg | Standard Deviation 12.912 |
| HCTZ 12.5mg | Baseline Average Daytime and Nighttime SBP | Daytime | 143.32 mmHg | Standard Deviation 12.637 |
Secondary
Baseline Fasting Plasma Glucose (FPG)
For FPG, blood was drawn after an overnight fast of at least 8 hours (except water).
Time frame: Baseline
Population: All randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Baseline Fasting Plasma Glucose (FPG) | 169.47 mg/dL | Standard Deviation 51.073 |
| Ertugliflozin 1 mg | Baseline Fasting Plasma Glucose (FPG) | 158.38 mg/dL | Standard Deviation 40.806 |
| Ertugliflozin 5 mg | Baseline Fasting Plasma Glucose (FPG) | 158.29 mg/dL | Standard Deviation 42.465 |
| Ertugliflozin 25 mg | Baseline Fasting Plasma Glucose (FPG) | 172.03 mg/dL | Standard Deviation 55.878 |
| HCTZ 12.5mg | Baseline Fasting Plasma Glucose (FPG) | 156.87 mg/dL | Standard Deviation 36.541 |
Secondary
Baseline Seated, Triplicate Trough DBP
Trough DBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. Baseline trough DBP is calculated as the mean of triplicate (3) trough DBP measures.
Time frame: Baseline
Population: All randomized participants who received at least one dose of study drug and had a baseline measurement for seated, triplicate, trough DBP.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Baseline Seated, Triplicate Trough DBP | 84.89 mmHg | Standard Deviation 9.462 |
| Ertugliflozin 1 mg | Baseline Seated, Triplicate Trough DBP | 83.08 mmHg | Standard Deviation 7.557 |
| Ertugliflozin 5 mg | Baseline Seated, Triplicate Trough DBP | 83.79 mmHg | Standard Deviation 7.904 |
| Ertugliflozin 25 mg | Baseline Seated, Triplicate Trough DBP | 83.89 mmHg | Standard Deviation 8.29 |
| HCTZ 12.5mg | Baseline Seated, Triplicate Trough DBP | 84.72 mmHg | Standard Deviation 8.043 |
Secondary
Baseline Seated, Triplicate Trough Heart Rate
Trough heart rate was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the heart rate measure was obtained. Three measurements of heart rate were taken at least 2-minutes apart. Baseline trough heart rate is calculated as the mean of triplicate (3) trough heart rate measures.
Time frame: Baseline
Population: All randomized participants who received at least one dose of study drug and had a baseline measurement for seated, triplicate, trough heart rate.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Baseline Seated, Triplicate Trough Heart Rate | 77.07 beats per minute | Standard Deviation 9.713 |
| Ertugliflozin 1 mg | Baseline Seated, Triplicate Trough Heart Rate | 78.73 beats per minute | Standard Deviation 8.446 |
| Ertugliflozin 5 mg | Baseline Seated, Triplicate Trough Heart Rate | 77.30 beats per minute | Standard Deviation 11.749 |
| Ertugliflozin 25 mg | Baseline Seated, Triplicate Trough Heart Rate | 75.63 beats per minute | Standard Deviation 9.55 |
| HCTZ 12.5mg | Baseline Seated, Triplicate Trough Heart Rate | 77.97 beats per minute | Standard Deviation 11.462 |
Secondary
Baseline Seated, Triplicate Trough SBP
Trough SBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. Baseline trough SBP is calculated as the mean of triplicate (3) trough SBP measures.
Time frame: Baseline
Population: All randomized participants who received at least one dose of study drug and had a baseline measurement for seated, triplicate, trough SBP.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Baseline Seated, Triplicate Trough SBP | 135.17 mmHg | Standard Deviation 14.183 |
| Ertugliflozin 1 mg | Baseline Seated, Triplicate Trough SBP | 134.23 mmHg | Standard Deviation 13.631 |
| Ertugliflozin 5 mg | Baseline Seated, Triplicate Trough SBP | 137.31 mmHg | Standard Deviation 14.834 |
| Ertugliflozin 25 mg | Baseline Seated, Triplicate Trough SBP | 135.25 mmHg | Standard Deviation 13.452 |
| HCTZ 12.5mg | Baseline Seated, Triplicate Trough SBP | 138.07 mmHg | Standard Deviation 12.958 |
Secondary
Change From Baseline in FPG at Week 2
For FPG, blood was drawn after an overnight fast of at least 8 hours (except water).
Time frame: Baseline and Week 2
Population: Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement at Week 2 for FPG (observed cases).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in FPG at Week 2 | -5.44 mg/dL |
| Ertugliflozin 1 mg | Change From Baseline in FPG at Week 2 | -10.98 mg/dL |
| Ertugliflozin 5 mg | Change From Baseline in FPG at Week 2 | -22.45 mg/dL |
| Ertugliflozin 25 mg | Change From Baseline in FPG at Week 2 | -32.03 mg/dL |
| HCTZ 12.5mg | Change From Baseline in FPG at Week 2 | 3.21 mg/dL |
p-value: 0.22480% CI: [-14.89, 3.82]Mixed Model for Repeated Measures
p-value: 0.01180% CI: [-26.39, -7.61]Mixed Model for Repeated Measures
p-value: 080% CI: [-35.84, -17.33]Mixed Model for Repeated Measures
p-value: 0.88680% CI: [-0.56, 17.87]Mixed Model for Repeated Measures
Secondary
Change From Baseline in FPG at Week 4
For FPG, blood was drawn after an overnight fast of at least 8 hours (except water).
Time frame: Baseline and Week 4
Population: Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement at Week 4 for FPG (observed cases).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in FPG at Week 4 | 4.39 mg/dL |
| Ertugliflozin 1 mg | Change From Baseline in FPG at Week 4 | -13.70 mg/dL |
| Ertugliflozin 5 mg | Change From Baseline in FPG at Week 4 | -30.41 mg/dL |
| Ertugliflozin 25 mg | Change From Baseline in FPG at Week 4 | -31.03 mg/dL |
| HCTZ 12.5mg | Change From Baseline in FPG at Week 4 | 3.79 mg/dL |
p-value: 0.00780% CI: [-27.45, -8.75]Mixed Model for Repeated Measures
p-value: 080% CI: [-44.19, -25.43]Mixed Model for Repeated Measures
p-value: 080% CI: [-44.78, -26.07]Mixed Model for Repeated Measures
p-value: 0.46780% CI: [-9.86, 8.65]Mixed Model for Repeated Measures
Secondary
Change From Baseline in Seated, Triplicate Trough DBP at Week 4
Trough DBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. The change from baseline at Week 4 is the difference between the baseline and Week 4 assessments.
Time frame: Baseline and Week 4
Population: Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement for sitting, triplicate trough DBP.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Seated, Triplicate Trough DBP at Week 4 | 0.30 mmHg |
| Ertugliflozin 1 mg | Change From Baseline in Seated, Triplicate Trough DBP at Week 4 | -0.90 mmHg |
| Ertugliflozin 5 mg | Change From Baseline in Seated, Triplicate Trough DBP at Week 4 | -0.75 mmHg |
| Ertugliflozin 25 mg | Change From Baseline in Seated, Triplicate Trough DBP at Week 4 | -2.71 mmHg |
| HCTZ 12.5mg | Change From Baseline in Seated, Triplicate Trough DBP at Week 4 | -2.54 mmHg |
p-value: 0.19680% CI: [-3.01, 0.6]Mixed Measures Repeated Model
p-value: 0.22980% CI: [-2.86, 0.77]Mixed Measures Repeated Model
p-value: 0.01780% CI: [-4.83, -1.2]Mixed Measures Repeated Model
p-value: 0.02180% CI: [-4.63, -1.06]Mixed Measures Repeated Model
Secondary
Change From Baseline in Seated, Triplicate Trough Heart Rate at Week 4
Trough heart rate was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the heart rate measure was obtained. Three measurements of heart rate were taken at least 2-minutes apart. The change from baseline at Week 4 is the difference between the baseline and Week 4 assessments.
Time frame: Baseline and Week 4
Population: Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement for sitting, triplicate trough heart rate.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Seated, Triplicate Trough Heart Rate at Week 4 | 2.34 beats per minute |
| Ertugliflozin 1 mg | Change From Baseline in Seated, Triplicate Trough Heart Rate at Week 4 | -1.86 beats per minute |
| Ertugliflozin 5 mg | Change From Baseline in Seated, Triplicate Trough Heart Rate at Week 4 | 1.22 beats per minute |
| Ertugliflozin 25 mg | Change From Baseline in Seated, Triplicate Trough Heart Rate at Week 4 | -1.51 beats per minute |
| HCTZ 12.5mg | Change From Baseline in Seated, Triplicate Trough Heart Rate at Week 4 | -0.99 beats per minute |
p-value: 0.00580% CI: [-6.3, -2.1]Mixed Model for Repeated Measures
p-value: 0.24880% CI: [-3.23, 0.99]Mixed Model for Repeated Measures
p-value: 0.0180% CI: [-5.95, -1.73]Mixed Model for Repeated Measures
p-value: 0.0280% CI: [-5.4, -1.25]Mixed Model for Repeated Measures
Secondary
Change From Baseline in Seated, Triplicate Trough SBP at Week 4
Trough SBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. The change from baseline at Week 4 is the difference between the baseline and Week 4 assessments.
Time frame: Baseline and Week 4
Population: Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement for sitting, triplicate trough SBP.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Seated, Triplicate Trough SBP at Week 4 | 1.24 mmHg |
| Ertugliflozin 1 mg | Change From Baseline in Seated, Triplicate Trough SBP at Week 4 | -2.77 mmHg |
| Ertugliflozin 5 mg | Change From Baseline in Seated, Triplicate Trough SBP at Week 4 | -5.92 mmHg |
| Ertugliflozin 25 mg | Change From Baseline in Seated, Triplicate Trough SBP at Week 4 | -4.96 mmHg |
| HCTZ 12.5mg | Change From Baseline in Seated, Triplicate Trough SBP at Week 4 | -3.13 mmHg |
p-value: 0.04780% CI: [-7.09, -0.94]Mixed Model for Repeated Measures
p-value: 0.00280% CI: [-10.25, -4.07]Mixed Model for Repeated Measures
p-value: 0.00580% CI: [-9.28, -3.11]Mixed Model for Repeated Measures
p-value: 0.03380% CI: [-7.41, -1.33]Mixed Model for Repeated Measures
Secondary
Change From Baseline on 24-hour Average DBP at Week 4
Change from baseline on 24-hour average DBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF.
Time frame: Baseline and Week 4
Population: Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline on 24-hour Average DBP at Week 4 | 0.77 mmHg |
| Ertugliflozin 1 mg | Change From Baseline on 24-hour Average DBP at Week 4 | -1.89 mmHg |
| Ertugliflozin 5 mg | Change From Baseline on 24-hour Average DBP at Week 4 | -2.34 mmHg |
| Ertugliflozin 25 mg | Change From Baseline on 24-hour Average DBP at Week 4 | -1.50 mmHg |
| HCTZ 12.5mg | Change From Baseline on 24-hour Average DBP at Week 4 | -1.42 mmHg |
p-value: 0.00780% CI: [-4.03, -1.29]ANCOVA
p-value: 0.00380% CI: [-4.55, -1.67]ANCOVA
p-value: 0.01880% CI: [-3.65, -0.88]ANCOVA
p-value: 0.02180% CI: [-3.56, -0.82]ANCOVA
Secondary
Change From Baseline on 24-hour Average Heart Rate at Week 4
Change from baseline in 24-hour average heart rate at Week 4 using 24 hour ABPM.
Time frame: Baseline and Week 4
Population: Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline on 24-hour Average Heart Rate at Week 4 | 1.00 Beats per minute |
| Ertugliflozin 1 mg | Change From Baseline on 24-hour Average Heart Rate at Week 4 | -1.22 Beats per minute |
| Ertugliflozin 5 mg | Change From Baseline on 24-hour Average Heart Rate at Week 4 | 1.07 Beats per minute |
| Ertugliflozin 25 mg | Change From Baseline on 24-hour Average Heart Rate at Week 4 | -1.39 Beats per minute |
| HCTZ 12.5mg | Change From Baseline on 24-hour Average Heart Rate at Week 4 | -0.56 Beats per minute |
p-value: 0.03980% CI: [-3.83, -0.61]ANCOVA
p-value: 0.52180% CI: [-1.63, 1.77]ANCOVA
p-value: 0.03180% CI: [-4.02, -0.75]ANCOVA
p-value: 0.1180% CI: [-3.19, 0.07]ANCOVA
Secondary
Change From Baseline on 24-hour Urinary Glucose Excretion at Week 4
Urinary glucose excetion was corrected for a duration of 24 hours (with appropriate duration of collection defined as \>20 hours and \<28 hours). In the case of missing data, LOCF.
Time frame: Baseline and Week 4
Population: Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement for 24-hour urinary glucose excretion.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline on 24-hour Urinary Glucose Excretion at Week 4 | 4.15 grams/day |
| Ertugliflozin 1 mg | Change From Baseline on 24-hour Urinary Glucose Excretion at Week 4 | 46.33 grams/day |
| Ertugliflozin 5 mg | Change From Baseline on 24-hour Urinary Glucose Excretion at Week 4 | 64.54 grams/day |
| Ertugliflozin 25 mg | Change From Baseline on 24-hour Urinary Glucose Excretion at Week 4 | 74.49 grams/day |
| HCTZ 12.5mg | Change From Baseline on 24-hour Urinary Glucose Excretion at Week 4 | -0.48 grams/day |
p-value: 080% CI: [31.42, 52.94]ANCOVA
p-value: 080% CI: [49.47, 71.31]ANCOVA
p-value: 080% CI: [59.58, 81.1]ANCOVA
p-value: 0.71380% CI: [-15.22, 5.96]ANCOVA
Secondary
Change From Baseline on Daytime Average DBP at Week 4
Change from baseline on daytime average DBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Daytime was defined as 0600 to 2159 hours, inclusive, local time.
Time frame: Baseline and Week 4
Population: Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline on Daytime Average DBP at Week 4 | 0.87 mmHg |
| Ertugliflozin 1 mg | Change From Baseline on Daytime Average DBP at Week 4 | -2.12 mmHg |
| Ertugliflozin 5 mg | Change From Baseline on Daytime Average DBP at Week 4 | -1.88 mmHg |
| Ertugliflozin 25 mg | Change From Baseline on Daytime Average DBP at Week 4 | -1.77 mmHg |
| HCTZ 12.5mg | Change From Baseline on Daytime Average DBP at Week 4 | -1.69 mmHg |
p-value: 0.00480% CI: [-4.43, -1.55]ANCOVA
p-value: 0.0180% CI: [-4.26, -1.24]ANCOVA
p-value: 0.0180% CI: [-4.09, -1.19]ANCOVA
p-value: 0.01180% CI: [-4, -1.13]ANCOVA
Secondary
Change From Baseline on Daytime Average Heart Rate at Week 4
Change from baseline in daytime average heart rate at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Daytime was defined as 0600 to 2159 hours, inclusive, local time.
Time frame: Baseline and Week 4
Population: Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline on Daytime Average Heart Rate at Week 4 | 1.58 Beats per minute |
| Ertugliflozin 1 mg | Change From Baseline on Daytime Average Heart Rate at Week 4 | -1.80 Beats per minute |
| Ertugliflozin 5 mg | Change From Baseline on Daytime Average Heart Rate at Week 4 | 1.10 Beats per minute |
| Ertugliflozin 25 mg | Change From Baseline on Daytime Average Heart Rate at Week 4 | -1.07 Beats per minute |
| HCTZ 12.5mg | Change From Baseline on Daytime Average Heart Rate at Week 4 | -0.06 Beats per minute |
p-value: 0.00780% CI: [-5.13, -1.63]ANCOVA
p-value: 0.3780% CI: [-2.33, 1.38]ANCOVA
p-value: 0.02980% CI: [-4.43, -0.87]ANCOVA
p-value: 0.11880% CI: [-3.42, 0.13]ANCOVA
Secondary
Change From Baseline on Daytime Average SBP at Week 4
Change from baseline on daytime average SBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Daytime was defined as 0600 to 2159 hours, inclusive, local time.
Time frame: Baseline and Week 4
Population: Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline on Daytime Average SBP at Week 4 | 0.82 mmHg |
| Ertugliflozin 1 mg | Change From Baseline on Daytime Average SBP at Week 4 | -2.88 mmHg |
| Ertugliflozin 5 mg | Change From Baseline on Daytime Average SBP at Week 4 | -3.61 mmHg |
| Ertugliflozin 25 mg | Change From Baseline on Daytime Average SBP at Week 4 | -4.17 mmHg |
| HCTZ 12.5mg | Change From Baseline on Daytime Average SBP at Week 4 | -3.10 mmHg |
p-value: 0.01880% CI: [-5.94, -1.46]ANCOVA
p-value: 0.00880% CI: [-6.78, -2.09]ANCOVA
p-value: 0.00280% CI: [-7.24, -2.74]ANCOVA
p-value: 0.01380% CI: [-6.16, -1.67]ANCOVA
Secondary
Change From Baseline on Nighttime Average DBP at Week 4
Change from baseline on nighttime average DBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.
Time frame: Baseline and Week 4
Population: Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline on Nighttime Average DBP at Week 4 | 1.02 mmHg |
| Ertugliflozin 1 mg | Change From Baseline on Nighttime Average DBP at Week 4 | -1.48 mmHg |
| Ertugliflozin 5 mg | Change From Baseline on Nighttime Average DBP at Week 4 | -2.52 mmHg |
| Ertugliflozin 25 mg | Change From Baseline on Nighttime Average DBP at Week 4 | -0.84 mmHg |
| HCTZ 12.5mg | Change From Baseline on Nighttime Average DBP at Week 4 | -0.55 mmHg |
p-value: 0.04880% CI: [-4.43, -0.57]ANCOVA
p-value: 0.01380% CI: [-5.58, -1.51]ANCOVA
p-value: 0.11180% CI: [-3.82, 0.09]ANCOVA
p-value: 0.14880% CI: [-3.51, 0.36]ANCOVA
Secondary
Change From Baseline on Nighttime Average Heart Rate at Week 4
Change from baseline in 24-hour nighttime average heart rate at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.
Time frame: Baseline and Week 4
Population: Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline on Nighttime Average Heart Rate at Week 4 | -0.18 Beats per minute |
| Ertugliflozin 1 mg | Change From Baseline on Nighttime Average Heart Rate at Week 4 | -0.15 Beats per minute |
| Ertugliflozin 5 mg | Change From Baseline on Nighttime Average Heart Rate at Week 4 | 1.43 Beats per minute |
| Ertugliflozin 25 mg | Change From Baseline on Nighttime Average Heart Rate at Week 4 | -1.99 Beats per minute |
| HCTZ 12.5mg | Change From Baseline on Nighttime Average Heart Rate at Week 4 | -1.24 Beats per minute |
p-value: 0.50680% CI: [-1.96, 2]ANCOVA
p-value: 0.83880% CI: [-0.49, 3.71]ANCOVA
p-value: 0.12380% CI: [-3.82, 0.19]ANCOVA
p-value: 0.24680% CI: [-3.06, 0.93]ANCOVA
Secondary
Change From Baseline on Nighttime Average SBP at Week 4
Change from baseline on nighttime average SBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.
Time frame: Baseline and Week 4
Population: Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline on Nighttime Average SBP at Week 4 | -0.29 mmHg |
| Ertugliflozin 1 mg | Change From Baseline on Nighttime Average SBP at Week 4 | -2.48 mmHg |
| Ertugliflozin 5 mg | Change From Baseline on Nighttime Average SBP at Week 4 | -3.47 mmHg |
| Ertugliflozin 25 mg | Change From Baseline on Nighttime Average SBP at Week 4 | -2.31 mmHg |
| HCTZ 12.5mg | Change From Baseline on Nighttime Average SBP at Week 4 | -2.30 mmHg |
p-value: 0.15280% CI: [-4.93, 0.54]ANCOVA
p-value: 0.07880% CI: [-6.06, -0.3]ANCOVA
p-value: 0.17480% CI: [-4.79, 0.74]ANCOVA
p-value: 0.17480% CI: [-4.77, 0.74]ANCOVA
Secondary
Number of Participants Who Discontinued Study Drug Due to an AE
An adverse event is defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. The table below includes all data collected since first dose of study drug. Discontinuation of study drug due to an AE includes temporary and permanent discontinuation of study drug due to an AE.
Time frame: Up to 28 days (treatment period)
Population: Analysis population consisted of all randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Who Discontinued Study Drug Due to an AE | 0 Participants |
| Ertugliflozin 1 mg | Number of Participants Who Discontinued Study Drug Due to an AE | 0 Participants |
| Ertugliflozin 5 mg | Number of Participants Who Discontinued Study Drug Due to an AE | 0 Participants |
| Ertugliflozin 25 mg | Number of Participants Who Discontinued Study Drug Due to an AE | 1 Participants |
| HCTZ 12.5mg | Number of Participants Who Discontinued Study Drug Due to an AE | 0 Participants |
Secondary
Number of Participants Who Experienced an Adverse Event (AE)
An adverse event is defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. The table below includes all data collected since first dose of study drug.
Time frame: Up to 63 days (including run-in, treatment period, and follow-up)
Population: Analysis population consisted of all randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Who Experienced an Adverse Event (AE) | 9 Participants |
| Ertugliflozin 1 mg | Number of Participants Who Experienced an Adverse Event (AE) | 8 Participants |
| Ertugliflozin 5 mg | Number of Participants Who Experienced an Adverse Event (AE) | 15 Participants |
| Ertugliflozin 25 mg | Number of Participants Who Experienced an Adverse Event (AE) | 12 Participants |
| HCTZ 12.5mg | Number of Participants Who Experienced an Adverse Event (AE) | 10 Participants |