Study of Safety and Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes And Hypertension (MK-8835-042)
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
3 other identifiers
interventional
194
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 diabetes-mellitus-type-2
Started May 2010
Shorter than P25 for phase_2 diabetes-mellitus-type-2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2010
CompletedFirst Posted
Study publicly available on registry
March 31, 2010
CompletedStudy Start
First participant enrolled
May 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2011
CompletedResults Posted
Study results publicly available
December 13, 2017
CompletedSeptember 13, 2018
August 1, 2018
9 months
March 26, 2010
November 15, 2017
August 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Baseline 24-hour Average Systolic Blood Pressure (SBP)
Baseline 24-hour average SBP was assessed using 24-hour ambulatory blood pressure monitoring (ABPM).
24 hours
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).
Baseline and Week 4
Secondary Outcomes (24)
Baseline Average Daytime and Nighttime SBP
Daytime: 16 hours; Nighttime: 8 hours
Change From Baseline on Daytime Average SBP at Week 4
Baseline and Week 4
Change From Baseline on Nighttime Average SBP at Week 4
Baseline and Week 4
Baseline Seated, Triplicate Trough SBP
Baseline
Change From Baseline in Seated, Triplicate Trough SBP at Week 4
Baseline and Week 4
- +19 more secondary outcomes
Study Arms (5)
Placebo
PLACEBO COMPARATORPlacebo to ertugliflozin (resembling either 1 mg or 5 mg), placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days.
Ertugliflozin 1 mg
EXPERIMENTALErtugliflozin 1 mg, placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days
Ertugliflozin 5 mg
EXPERIMENTALErtugliflozin 5 mg, placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days
Ertugliflozin 25 mg
EXPERIMENTALErtugliflozin 25 mg, placebo to ertugliflozin (resembling either 1 mg or 5 mg), and placebo to HCTZ once daily for 28 days
HCTZ 12.5mg
ACTIVE COMPARATORHCTZ 12.5 mg, placebo to ertugliflozin (resembling either 1 mg or 5 mg), and placebo to ertugliflozin (resembling 25 mg) once daily for 28 days
Interventions
Placebo to ertuglilflozin tablet 1 or 5 mg once daily for 28 days
Placebo to HCTZ 12.5 mg capsule once daily for 28 days
Placebo to ertuglilflozin tablet 25 mg once daily for 28 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Participants with type 1 diabetes
- Heart attack
- Stroke
- Uncontrolled blood pressure
- Significant kidney disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Merck Sharp & Dohme LLClead
- Pfizercollaborator
Related Publications (2)
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.
PMID: 25951755RESULTFediuk 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.
PMID: 34213819DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2010
First Posted
March 31, 2010
Study Start
May 17, 2010
Primary Completion
February 9, 2011
Study Completion
February 25, 2011
Last Updated
September 13, 2018
Results First Posted
December 13, 2017
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will share
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf