Diabetes Mellitus, Type 2Phase 2NCT01096667
Study of Safety and Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes And Hypertension (MK-8835-042)
A Phase 2 study testing Ertugliflozin 1 mg, Ertugliflozin 5 mg and Ertugliflozin 25 mg in people with Diabetes Mellitus, Type 2 and Hypertension, run by Merck Sharp & Dohme LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hypertension
- What is being tested?
- Ertugliflozin 1 mg, Ertugliflozin 5 mg and Ertugliflozin 25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 194 participants
- Where
- No sites listed yet
- Study dates
- 17 May 2010to 25 Feb 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants with type 1 diabetes
- Heart attack
- Stroke
- Uncontrolled blood pressure
- Significant kidney disease
About this study
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
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.
- Conditions
- Diabetes Mellitus, Type 2, Hypertension
- Being tested
- Placebo to Ertuglilflozin 1 or 5 mg, Ertugliflozin 1 mg, Ertugliflozin 5 mg, Ertugliflozin 25 mg, HCTZ 12.5mg
- Keywords
- type 2 diabetes, hypertension, ambulatory blood pressure monitoring
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo to Ertuglilflozin 1 or 5 mgDrug
Placebo to ertuglilflozin tablet 1 or 5 mg once daily for 28 days
Ertugliflozin 1 mgDrug
Ertugliflozin tablet 1 mg once daily for 28 days
Ertugliflozin 5 mgDrug
Ertugliflozin tablet 5 mg once daily for 28 days
Ertugliflozin 25 mgDrug
Ertugliflozin tablet 25 mg once daily for 28 days
HCTZ 12.5mgDrug
Hydrocholorthiazide (HCTZ) 12.5 mg capsule once daily for 28 days
Placebo to HCTZDrug
Placebo to HCTZ 12.5 mg capsule once daily for 28 days
Placebo to ertuglilflozin 25 mgDrug
Placebo to ertuglilflozin tablet 25 mg once daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo to Ertuglilflozin 1 or 5 mg; Drug: Placebo to HCTZ; Drug: Placebo to ertuglilflozin 25 mg |
| Ertugliflozin 1 mg | Experimental | Ertugliflozin 1 mg, placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days Receives: Drug: Ertugliflozin 1 mg; Drug: Placebo to HCTZ; Drug: Placebo to ertuglilflozin 25 mg |
| Ertugliflozin 5 mg | Experimental | Ertugliflozin 5 mg, placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days Receives: Drug: Ertugliflozin 5 mg; Drug: Placebo to HCTZ; Drug: Placebo to ertuglilflozin 25 mg |
| Ertugliflozin 25 mg | Experimental | Ertugliflozin 25 mg, placebo to ertugliflozin (resembling either 1 mg or 5 mg), and placebo to HCTZ once daily for 28 days Receives: Drug: Placebo to Ertuglilflozin 1 or 5 mg; Drug: Ertugliflozin 25 mg; Drug: Placebo to HCTZ |
| HCTZ 12.5mg | Active comparator | 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 Receives: Drug: Placebo to Ertuglilflozin 1 or 5 mg; Drug: HCTZ 12.5mg; Drug: Placebo to ertuglilflozin 25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline 24-hour Average Systolic Blood Pressure (SBP)
Baseline 24-hour average SBP was assessed using 24-hour ambulatory blood pressure monitoring (ABPM).
Measured: 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).
Measured: Baseline and Week 4
Secondary outcomes (24)
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.
Measured: Daytime: 16 hours; Nighttime: 8 hours
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.
Measured: Baseline and Week 4
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.
Measured: Baseline and Week 4
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.
Measured: Baseline
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.
Measured: Baseline and Week 4
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.
Measured: up to 24 hours
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.
Measured: Baseline and Week 4
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.
Measured: Baseline and Week 4
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.
Measured: Baseline and Week 4
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.
Measured: Baseline
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.
Measured: Baseline and Week 4
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.
Measured: up to 24 hours
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.
Measured: Baseline and Week 4
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.
Measured: Baseline and Week 4
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.
Measured: Baseline and Week 4
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.
Measured: Baseline
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.
Measured: Baseline and Week 4
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).
Measured: 24 hours
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.
Measured: Baseline and Week 4
Baseline Fasting Plasma Glucose (FPG)
For FPG, blood was drawn after an overnight fast of at least 8 hours (except water).
Measured: Baseline
Change From Baseline in FPG at Week 4
For FPG, blood was drawn after an overnight fast of at least 8 hours (except water).
Measured: Baseline and Week 4
Change From Baseline in FPG at Week 2
For FPG, blood was drawn after an overnight fast of at least 8 hours (except water).
Measured: Baseline and Week 2
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.
Measured: Up to 63 days (including run-in, treatment period, and follow-up)
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.
Measured: Up to 28 days (treatment period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study start17 May 2010
- Primary completion9 Feb 2011
- Study completion25 Feb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096667
- Sponsor's protocol ID
- 8835-042
- Other IDs
- B1521004, MK-8835-042
- Status last verified
- Aug 2018
- First submitted
- 26 Mar 2010
- Last updated
- 13 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
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.
PubMed 25951755Fediuk 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.
PubMed 34213819
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01096667
- Acronym / sponsor ID
- 8835-042
- Conditions
- Diabetes Mellitus, Type 2, Hypertension
- Keywords
- type 2 diabetes, hypertension, ambulatory blood pressure monitoring
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 17 May 2010 (actual)
- Primary completion
- 9 Feb 2011 (actual)
- Study completion
- 25 Feb 2011 (actual)
- First posted
- 31 Mar 2010 (estimated)
- Results
- Posted 13 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo to Ertuglilflozin 1 or 5 mg, Drug: Placebo to HCTZ, Drug: Placebo to ertuglilflozin 25 mgPlacebo 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 | Experimental | Drug: Ertugliflozin 1 mg, Drug: Placebo to HCTZ, Drug: Placebo to ertuglilflozin 25 mgErtugliflozin 1 mg, placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days |
| Ertugliflozin 5 mg | Experimental | Drug: Ertugliflozin 5 mg, Drug: Placebo to HCTZ, Drug: Placebo to ertuglilflozin 25 mgErtugliflozin 5 mg, placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days |
| Ertugliflozin 25 mg | Experimental | Drug: Placebo to Ertuglilflozin 1 or 5 mg, Drug: Ertugliflozin 25 mg, Drug: Placebo to HCTZErtugliflozin 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 comparator | Drug: Placebo to Ertuglilflozin 1 or 5 mg, Drug: HCTZ 12.5mg, Drug: Placebo to ertuglilflozin 25 mgHCTZ 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Participants with type 1 diabetes
- Heart attack
- Stroke
- Uncontrolled blood pressure
- Significant kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo to Ertuglilflozin 1 or 5 mgPlacebo to ertuglilflozin tablet 1 or 5 mg once daily for 28 days | Drug | Ertugliflozin 25 mg, HCTZ 12.5mg, Placebo |
| Ertugliflozin 1 mgErtugliflozin tablet 1 mg once daily for 28 days | Drug | Ertugliflozin 1 mg |
| Ertugliflozin 5 mgErtugliflozin tablet 5 mg once daily for 28 days | Drug | Ertugliflozin 5 mg |
| Ertugliflozin 25 mgErtugliflozin tablet 25 mg once daily for 28 days | Drug | Ertugliflozin 25 mg |
| HCTZ 12.5mgHydrocholorthiazide (HCTZ) 12.5 mg capsule once daily for 28 days | Drug | HCTZ 12.5mg |
| Placebo to HCTZPlacebo to HCTZ 12.5 mg capsule once daily for 28 days | Drug | Ertugliflozin 1 mg, Ertugliflozin 25 mg, Ertugliflozin 5 mg, Placebo |
| Placebo to ertuglilflozin 25 mgPlacebo to ertuglilflozin tablet 25 mg once daily for 28 days | Drug | Ertugliflozin 1 mg, Ertugliflozin 5 mg, HCTZ 12.5mg, Placebo |
Primary outcome
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).
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).
24 secondary outcomes
Baseline Average Daytime and Nighttime SBP
Time frame: 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 Nighttime Average SBP at Week 4
Time frame: Baseline and Week 4
Baseline Seated, Triplicate Trough SBP
Time frame: Baseline
Change From Baseline in Seated, Triplicate Trough SBP at Week 4
Time frame: Baseline and Week 4
Baseline 24-hour, Daytime and Nightime Average Diastolic Blood Pressure (DBP)
Time frame: 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 Daytime Average DBP at Week 4
Time frame: Baseline and Week 4
Change From Baseline on Nighttime Average DBP at Week 4
Time frame: Baseline and Week 4
Baseline Seated, Triplicate Trough DBP
Time frame: Baseline
Change From Baseline in Seated, Triplicate Trough DBP at Week 4
Time frame: Baseline and Week 4
Baseline 24-hour, Daytime and Nightime Average Heart Rate
Time frame: 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 on Daytime Average Heart Rate at Week 4
Time frame: Baseline and Week 4
Change From Baseline on Nighttime Average Heart Rate at Week 4
Time frame: Baseline and Week 4
Baseline Seated, Triplicate Trough Heart Rate
Time frame: Baseline
Change From Baseline in Seated, Triplicate Trough Heart Rate at Week 4
Time frame: Baseline and Week 4
Baseline 24-hour Average Urinary Glucose Excretion
Time frame: 24 hours
Change From Baseline on 24-hour Urinary Glucose Excretion at Week 4
Time frame: Baseline and Week 4
Baseline Fasting Plasma Glucose (FPG)
Time frame: Baseline
Change From Baseline in FPG at Week 4
Time frame: Baseline and Week 4
Change From Baseline in FPG at Week 2
Time frame: 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)
Number of Participants Who Discontinued Study Drug Due to an AE
Time frame: Up to 28 days (treatment period)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25951755Amin 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.
- Derived from this study: PubMed 34213819Fediuk 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.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ertugliflozin 1 mg, Ertugliflozin 5 mg and Ertugliflozin 25 mg in people with Diabetes Mellitus, Type 2 and Hypertension, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline 24-hour Average Systolic Blood Pressure (SBP) (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01096667, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2018.