Clinical trial NCT01096667: Study of Safety and Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes And Hypertension (MK-8835-042)
Official title: A 4-Week, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Study To Evaluate The Safety, Tolerability And Efficacy Of Once Daily PF-04971729 And Hydrochlorothiazide In Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic And Blood Pressure Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Hypertension
Keywords: type 2 diabetes
hypertension
ambulatory blood pressure monitoring
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2010-03-31
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Baseline 24-hour Average Systolic Blood Pressure (SBP)
timeFrame: 24 hours
measure: Change From Baseline on 24-hour Average SBP at Week 4
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: Baseline Average Daytime and Nighttime SBP
timeFrame: Daytime: 16 hours; Nighttime: 8 hours
measure: Change From Baseline on Daytime Average SBP at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline on Nighttime Average SBP at Week 4
timeFrame: Baseline and Week 4
measure: Baseline Seated, Triplicate Trough SBP
timeFrame: Baseline
measure: Change From Baseline in Seated, Triplicate Trough SBP at Week 4
timeFrame: Baseline and Week 4
measure: Baseline 24-hour, Daytime and Nightime Average Diastolic Blood Pressure (DBP)
timeFrame: up to 24 hours
measure: Change From Baseline on 24-hour Average DBP at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline on Daytime Average DBP at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline on Nighttime Average DBP at Week 4
timeFrame: Baseline and Week 4
measure: Baseline Seated, Triplicate Trough DBP
timeFrame: Baseline
measure: Change From Baseline in Seated, Triplicate Trough DBP at Week 4
timeFrame: Baseline and Week 4
measure: Baseline 24-hour, Daytime and Nightime Average Heart Rate
timeFrame: up to 24 hours
measure: Change From Baseline on 24-hour Average Heart Rate at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline on Daytime Average Heart Rate at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline on Nighttime Average Heart Rate at Week 4
timeFrame: Baseline and Week 4
measure: Baseline Seated, Triplicate Trough Heart Rate
timeFrame: Baseline
measure: Change From Baseline in Seated, Triplicate Trough Heart Rate at Week 4
timeFrame: Baseline and Week 4
measure: Baseline 24-hour Average Urinary Glucose Excretion
timeFrame: 24 hours
measure: Change From Baseline on 24-hour Urinary Glucose Excretion at Week 4
timeFrame: Baseline and Week 4
measure: Baseline Fasting Plasma Glucose (FPG)
timeFrame: Baseline
measure: Change From Baseline in FPG at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in FPG at Week 2
timeFrame: Baseline and Week 2
measure: Number of Participants Who Experienced an Adverse Event (AE)
timeFrame: Up to 63 days (including run-in, treatment period, and follow-up)
measure: Number of Participants Who Discontinued Study Drug Due to an AE
timeFrame: Up to 28 days (treatment period)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Amin NB, Wang X, Mitchell JR, Lee DS, Nucci G, Rusnak JM. Blood pressure-lowering effect of the sodium glucose co-transporter-2 inhibitor ertugliflozin, assessed via ambulatory blood pressure monitoring in patients with type 2 diabetes and hypertension. Diabetes Obes Metab. 2015 Aug;17(8):805-8. doi: 10.1111/dom.12486. Epub 2015 Jun 17.
citation: Fediuk DJ, Sahasrabudhe V, Dawra VK, Zhou S, Sweeney K. Population Pharmacokinetic Analyses of Ertugliflozin in Select Ethnic Populations. Clin Pharmacol Drug Dev. 2021 Nov;10(11):1297-1306. doi: 10.1002/cpdd.970. Epub 2021 Jul 2.