Study of Safety and Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes And Hypertension (MK-8835-042)

August 15, 2018 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
194

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo to ertugliflozin (resembling either 1 mg or 5 mg), placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days.
Drug: Placebo to Ertuglilflozin 1 or 5 mg
Placebo to ertuglilflozin tablet 1 or 5 mg once daily for 28 days
Drug: Placebo to HCTZ
Placebo to HCTZ 12.5 mg capsule once daily for 28 days
Drug: Placebo to ertuglilflozin 25 mg
Placebo to ertuglilflozin tablet 25 mg once daily for 28 days
Experimental: Ertugliflozin 1 mg
Ertugliflozin 1 mg, placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days
Drug: Placebo to HCTZ
Placebo to HCTZ 12.5 mg capsule once daily for 28 days
Drug: Placebo to ertuglilflozin 25 mg
Placebo to ertuglilflozin tablet 25 mg once daily for 28 days
Drug: Ertugliflozin 1 mg
Ertugliflozin tablet 1 mg once daily for 28 days
Experimental: Ertugliflozin 5 mg
Ertugliflozin 5 mg, placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days
Drug: Placebo to HCTZ
Placebo to HCTZ 12.5 mg capsule once daily for 28 days
Drug: Placebo to ertuglilflozin 25 mg
Placebo to ertuglilflozin tablet 25 mg once daily for 28 days
Drug: Ertugliflozin 5 mg
Ertugliflozin tablet 5 mg once daily for 28 days
Experimental: Ertugliflozin 25 mg
Ertugliflozin 25 mg, placebo to ertugliflozin (resembling either 1 mg or 5 mg), and placebo to HCTZ once daily for 28 days
Drug: Placebo to Ertuglilflozin 1 or 5 mg
Placebo to ertuglilflozin tablet 1 or 5 mg once daily for 28 days
Drug: Placebo to HCTZ
Placebo to HCTZ 12.5 mg capsule once daily for 28 days
Drug: Ertugliflozin 25 mg
Ertugliflozin tablet 25 mg once daily for 28 days
Active Comparator: HCTZ 12.5mg
HCTZ 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
Drug: Placebo to Ertuglilflozin 1 or 5 mg
Placebo to ertuglilflozin tablet 1 or 5 mg once daily for 28 days
Drug: Placebo to ertuglilflozin 25 mg
Placebo to ertuglilflozin tablet 25 mg once daily for 28 days
Drug: HCTZ 12.5mg
Hydrocholorthiazide (HCTZ) 12.5 mg capsule once daily for 28 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Baseline 24-hour Average Systolic Blood Pressure (SBP)
Time Frame: 24 hours
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
Time Frame: 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).
Baseline and Week 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Baseline Average Daytime and Nighttime SBP
Time Frame: 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.
Daytime: 16 hours; Nighttime: 8 hours
Change From Baseline on Daytime Average SBP at Week 4
Time Frame: 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.
Baseline and Week 4
Change From Baseline on Nighttime Average SBP at Week 4
Time Frame: 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 and Week 4
Baseline Seated, Triplicate Trough SBP
Time Frame: 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.
Baseline
Change From Baseline in Seated, Triplicate Trough SBP at Week 4
Time Frame: 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 and Week 4
Baseline 24-hour, Daytime and Nightime Average Diastolic Blood Pressure (DBP)
Time Frame: 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.
up to 24 hours
Change From Baseline on 24-hour Average DBP at Week 4
Time Frame: 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.
Baseline and Week 4
Change From Baseline on Daytime Average DBP at Week 4
Time Frame: 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.
Baseline and Week 4
Change From Baseline on Nighttime Average DBP at Week 4
Time Frame: 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 and Week 4
Baseline Seated, Triplicate Trough DBP
Time Frame: 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.
Baseline
Change From Baseline in Seated, Triplicate Trough DBP at Week 4
Time Frame: 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 and Week 4
Baseline 24-hour, Daytime and Nightime Average Heart Rate
Time Frame: 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.
up to 24 hours
Change From Baseline on 24-hour Average Heart Rate at Week 4
Time Frame: Baseline and Week 4
Change from baseline in 24-hour average heart rate at Week 4 using 24 hour ABPM.
Baseline and Week 4
Change From Baseline on Daytime Average Heart Rate at Week 4
Time Frame: 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.
Baseline and Week 4
Change From Baseline on Nighttime Average Heart Rate at Week 4
Time Frame: 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 and Week 4
Baseline Seated, Triplicate Trough Heart Rate
Time Frame: 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.
Baseline
Change From Baseline in Seated, Triplicate Trough Heart Rate at Week 4
Time Frame: 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 and Week 4
Baseline 24-hour Average Urinary Glucose Excretion
Time Frame: 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).
24 hours
Change From Baseline on 24-hour Urinary Glucose Excretion at Week 4
Time Frame: 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 and Week 4
Baseline Fasting Plasma Glucose (FPG)
Time Frame: Baseline
For FPG, blood was drawn after an overnight fast of at least 8 hours (except water).
Baseline
Change From Baseline in FPG at Week 4
Time Frame: Baseline and Week 4
For FPG, blood was drawn after an overnight fast of at least 8 hours (except water).
Baseline and Week 4
Change From Baseline in FPG at Week 2
Time Frame: Baseline and Week 2
For FPG, blood was drawn after an overnight fast of at least 8 hours (except water).
Baseline and Week 2
Number of Participants Who Experienced an Adverse Event (AE)
Time Frame: 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.
Up to 63 days (including run-in, treatment period, and follow-up)
Number of Participants Who Discontinued Study Drug Due to an AE
Time Frame: 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.
Up to 28 days (treatment period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 9, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 25, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 8835-042
  • B1521004 (Other Identifier: Pfizer protocol number)
  • MK-8835-042 (Other Identifier: Merck Protocol Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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