Phase 2
Completed N=194
Study of Safety and Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes And Hypertension (MK-8835-042)
Source: ClinicalTrials.gov NCT01096667 ↗Enrolled (actual)
194
Serious AEs
0.5%
Results posted
Dec 2017
Primary outcomePrimary: Baseline 24-hour Average Systolic Blood Pressure (SBP) — 136.11; 133.13; 135.08; 135.59 mmHg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline 24-hour Average Systolic Blood Pressure (SBP) |
136.11; 133.13; 135.08; 135.59; 139.55 | — |
| PRIMARY Change From Baseline on 24-hour Average SBP at Week 4 |
0.26; -2.71; -3.73; -3.42; -2.95 | 0.034 sig |
| SECONDARY Baseline Average Daytime and Nighttime SBP |
139.95; 136.85; 138.89; 139.56; 143.32; 127.54 | — |
| SECONDARY Change From Baseline on Daytime Average SBP at Week 4 |
0.82; -2.88; -3.61; -4.17; -3.10 | 0.018 sig |
| SECONDARY Change From Baseline on Nighttime Average SBP at Week 4 |
-0.29; -2.48; -3.47; -2.31; -2.30 | 0.152 |
| SECONDARY Baseline Seated, Triplicate Trough SBP |
135.17; 134.23; 137.31; 135.25; 138.07 | — |
| SECONDARY Change From Baseline in Seated, Triplicate Trough SBP at Week 4 |
1.24; -2.77; -5.92; -4.96; -3.13 | 0.047 sig |
| SECONDARY Baseline 24-hour, Daytime and Nightime Average Diastolic Blood Pressure (DBP) |
81.89; 78.67; 80.18; 80.36; 82.66; 85.32 | — |
| SECONDARY Change From Baseline on 24-hour Average DBP at Week 4 |
0.77; -1.89; -2.34; -1.50; -1.42 | 0.007 sig |
| SECONDARY Change From Baseline on Daytime Average DBP at Week 4 |
0.87; -2.12; -1.88; -1.77; -1.69 | 0.004 sig |
| SECONDARY Change From Baseline on Nighttime Average DBP at Week 4 |
1.02; -1.48; -2.52; -0.84; -0.55 | 0.048 sig |
| SECONDARY Baseline Seated, Triplicate Trough DBP |
84.89; 83.08; 83.79; 83.89; 84.72 | — |
| SECONDARY Change From Baseline in Seated, Triplicate Trough DBP at Week 4 |
0.30; -0.90; -0.75; -2.71; -2.54 | 0.196 |
| SECONDARY Baseline 24-hour, Daytime and Nightime Average Heart Rate |
81.11; 80.74; 79.68; 79.41; 79.08; 84.43 | — |
| SECONDARY Change From Baseline on 24-hour Average Heart Rate at Week 4 |
1.00; -1.22; 1.07; -1.39; -0.56 | 0.039 sig |
| SECONDARY Change From Baseline on Daytime Average Heart Rate at Week 4 |
1.58; -1.80; 1.10; -1.07; -0.06 | 0.007 sig |
| SECONDARY Change From Baseline on Nighttime Average Heart Rate at Week 4 |
-0.18; -0.15; 1.43; -1.99; -1.24 | 0.506 |
| SECONDARY Baseline Seated, Triplicate Trough Heart Rate |
77.07; 78.73; 77.30; 75.63; 77.97 | — |
| SECONDARY Change From Baseline in Seated, Triplicate Trough Heart Rate at Week 4 |
2.34; -1.86; 1.22; -1.51; -0.99 | 0.005 sig |
| SECONDARY Baseline 24-hour Average Urinary Glucose Excretion |
13.35; 9.97; 8.04; 17.56; 6.96 | — |
| SECONDARY Change From Baseline on 24-hour Urinary Glucose Excretion at Week 4 |
4.15; 46.33; 64.54; 74.49; -0.48 | 0.000 sig |
| SECONDARY Baseline Fasting Plasma Glucose (FPG) |
169.47; 158.38; 158.29; 172.03; 156.87 | — |
| SECONDARY Change From Baseline in FPG at Week 4 |
4.39; -13.70; -30.41; -31.03; 3.79 | 0.007 sig |
| SECONDARY Change From Baseline in FPG at Week 2 |
-5.44; -10.98; -22.45; -32.03; 3.21 | 0.224 |
| SECONDARY Number of Participants Who Experienced an Adverse Event (AE) |
9; 8; 15; 12; 10 | — |
| SECONDARY Number of Participants Who Discontinued Study Drug Due to an AE |
0; 0; 0; 1; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01096667). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.