Diabetes Mellitus, Type 2Phase 1NCT01054300

Effects of Once and Twice Daily Dosing Regimen of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-040)

A Phase 1 study testing Ertugliflozin 2 mg single dose, Ertugliflozin 2 mg split into twice daily and Ertugliflozin 4 mg single dose in people with Diabetes Mellitus, Type 2 and Adult, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a Phase 1 randomized, double-blind, sponsor open, 4 arm, 2 way cross-over study using 2 cohorts. The objective of the study is to evaluate the pharmacodynamics (PD) effects and the pharmacokinetic (PK) of single day dosing of 2 mg and 4 mg doses of ertugliflozin (Ertu, PF-04971729/MK-8835) each administered… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Diabetes Mellitus, Type 2, Adult
What is being tested?: Ertugliflozin 2 mg single dose, Ertugliflozin 2 mg split into twice daily and Ertugliflozin 4 mg single dose
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 52 participants
Where: No sites listed yet
Study dates: 17 Feb 2010to 7 Apr 2010
Phase: Phase 1
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 mellitus, either treatment-naïve or on up to 2 acceptable oral anti-diabetes drugs for at least 8-weeks prior to study.

Who cannot join

Participants with type 1 diabetes mellitus, participants with stroke, unstable angina, heart attack in last 6-months, uncontrolled blood pressure.

About this study

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, 2-Period, Cross-Over Single Day Evaluation Of The Pharmacokinetic-Pharmacodynamic Effect Of Once And Twice Daily Oral Administration Of PF-04971729 In Patients With Type 2 Diabetes Mellitus

Conditions: Diabetes Mellitus, Type 2, Adult
Being tested: Ertugliflozin 2 mg single dose, Ertugliflozin 2 mg split into twice daily, Ertugliflozin 4 mg single dose, Ertugliflozin 4 mg split into twice daily, Placebo
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ertugliflozin 2 mg single doseDrug
Ertugliflozin 2 mg dose (two 1 mg strength tablets), administered as a single dose
Ertugliflozin 2 mg split into twice dailyDrug
Ertugliflozin 1 mg dose (1 mg strength tablet) administered twice daily x 1 day
Ertugliflozin 4 mg single doseDrug
Ertugliflozin 4 mg dose (four 1 mg strength tablets), administered as a single dose
Ertugliflozin 4 mg split into twice dailyDrug
Ertugliflozin 2 mg dose (two 1 mg strength tablets) administered twice daily x 1 day
PlaceboDrug
Placebo to ertugliflozin administered as a single dose

Study groups in NCT01054300
Study group	Role	What they receive
Cohort 1: Ertu 2 mg/Placebo (Pbo)→Ertu 1 mg/Ertu 1 mg	Experimental	Period 1: Ertu 2 mg in the AM and Pbo in the PM for 1 day. Period 2: Ertu 1 mg in the AM and Ertu 1 mg in the PM for 1 day. There was a >= 7 day washout period between Period 1 and Period 2. Receives: Drug: Ertugliflozin 2 mg single dose; Drug: Ertugliflozin 2 mg split into twice daily; Drug: Placebo
Cohort 1: Ertu 1 mg/Ertu 1 mg→Ertu 2 mg/Pbo	Experimental	Period 1: Ertu 1 mg in the AM and Ertu 1 mg in the PM for 1 day. Period 2: Ertu 2 mg in the AM and Pbo in the PM for 1 day. There was a >= 7 day washout period between Period 1 and Period 2. Receives: Drug: Ertugliflozin 2 mg single dose; Drug: Ertugliflozin 2 mg split into twice daily; Drug: Placebo
Cohort 2: Ertu 4 mg/Pbo→Ertu 2 mg/Ertu 2 mg	Experimental	Period 1: Ertu 4 mg in the AM and Pbo in the PM for 1 day. Period 2: Ertu 2 mg in the AM and Ertu 2 mg in the PM for 1 day. There was a >= 7 day washout period between Period 1 and Period 2. Receives: Drug: Ertugliflozin 4 mg single dose; Drug: Ertugliflozin 4 mg split into twice daily; Drug: Placebo
Cohort 2: Ertu 2 mg/Ertu 2 mg→Ertu 4 mg/Pbo	Experimental	Period 1: Ertu 2 mg in the AM and Ertu 2 mg in the PM for 1 day. Period 2: Ertu 4 mg in the AM and Pbo in the PM for 1 day. There was a >= 7 day washout period between Period 1 and Period 2. Receives: Drug: Ertugliflozin 4 mg single dose; Drug: Ertugliflozin 4 mg split into twice daily; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Cumulative Urinary Glucose Excretion Over 0 to 24 Hours
Urine for analysis of glucose was collected at prespecified intervals. Each participant emptied his/her bladder just before dosing, and the collection started after the morning dose (collection times: 0-4 hours, 4-8 hours, 8-12 hours, and 12-24 hours after the morning dose). The average amount of urinary glucose excreted from 0 to 24 hours after the morning dose is presented in the table below.
Measured: 0 to 24 hours after the morning dose
Urinary Glucose Excretion by Time Period
Urine for analysis of glucose was collected at prespecified intervals. Each participant emptied his/her bladder just before dosing, and the collection started after the morning dose (collection times: 0-4 hours, 4-8 hours, 8-12 hours, and 12-24 hours after the morning dose). The average amount of urinary glucose excreted during the pre-specified time frame is presented in the table below.
Measured: At 0-4 hrs, 4-8 hrs, 8-12 hrs, and 12-24 hrs after the AM dose (up to 24 hours)
24-hour Weighted Mean Plasma Glucose
Blood was collected during each treatment period at pre-dose (fasted) on Day 1 (Hour 0) and post-dose (fed) on Day 1 at 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 12.5, 13, 14, 15, 16, 18, and 24 hours.
Measured: Up to 24 hours
Weighted Mean Postprandial Plasma Glucose
The weighted mean postprandial glucose over the specified intervals were analyzed by cohort.
Measured: At 0-5 hours, 5-12 hrs, and 12-18 hrs after the morning dose (up to 18 hours)
Fasting Plasma Glucose
Blood samples were to be collected following a fast from all food and drink (except water) for at least 8 hours. Fasting Plasma Glucose was collected as part of the assessment of weighted mean 24-hour plasma glucose. As such, it was not specified as an endpoint in the Statistical Analysis Plan and was not analyzed or summarized separately.
Measured: Up to 24 hours
Fasting C-peptide
The fasting c-peptide was analyzed by cohort using a mixed-effects model with sequence, period, and treatment as fixed effects and participant within sequence as a random effect.
Measured: Up to 24 hours (0 and 24 hours)
Number of Participants Experiencing an Adverse Event
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a product or medical device. The table below includes all data collected since the first dose of study drug.
Measured: Up to 16 days
Number of Participants Discontinuing Study Drug Due to an Adverse Event
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a product or medical device. The table below includes all data collected since the first dose of study drug. Data include participants discontinued due to adverse events, participants with dose reduced or temporary discontinuation due to adverse events.
Measured: Up to 8 days (Day 1 in each dosing period)
Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUClast) for Ertugliflozin
Pharmacokinetic (PK) parameter of AUClast for study drug. Actual sample collection times (relative to the AM dose) were used for the pharmacokinetic analysis.
Measured: 0 predose, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 18, 24 hours postdose
Maximum Plasma Concentration (Cmax) of Ertugliflozin
PK parameter of Cmax for study drug. Actual sample collection times (relative to the AM dose) were used for the pharmacokinetic analysis.
Measured: 0 predose, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 18, 24 hours postdose
Time Taken to Reach the Maximum Observed Plasma Concentration (Tmax) of Ertugliflozin
PK parameter of Tmax for study drug. Actual sample collection times (relative to the AM dose) were used for the pharmacokinetic analysis.
Measured: 0 predose, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 18, 24 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Feb 20107 Apr 2010

First posted22 Jan 2010 (estimated)
Study start17 Feb 2010
Primary completion7 Apr 2010
Study completion7 Apr 2010

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 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01054300
Sponsor's protocol ID: 8835-040
Other IDs: B1521007, MK-8835-040
Status last verified: Nov 2019
First submitted: 20 Jan 2010
Last updated: 21 Nov 2019
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

Dawra VK, Liang Y, Shi H, Bass A, Hickman A, Terra SG, Zhou S, Cutler D, Sahasrabudhe V. A PK/PD study comparing twice-daily to once-daily dosing regimens of ertugliflozin in healthy subjects . Int J Clin Pharmacol Ther. 2019 Apr;57(4):207-216. doi: 10.5414/CP203343.
PubMed 30802200
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.
PubMed 34213819

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Recruiting
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Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, 2-Period, Cross-Over Single Day Evaluation Of The Pharmacokinetic-Pharmacodynamic Effect Of Once And Twice Daily Oral Administration Of PF-04971729 In Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01054300
Acronym / sponsor ID: 8835-040
Conditions: Diabetes Mellitus, Type 2, Adult
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: 17 Feb 2010 (actual)
Primary completion: 7 Apr 2010 (actual)
Study completion: 7 Apr 2010 (actual)
First posted: 22 Jan 2010 (estimated)
Results: Posted 7 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Cohort 1: Ertu 2 mg/Placebo (Pbo)→Ertu 1 mg/Ertu 1 mg	Experimental	Drug: Ertugliflozin 2 mg single dose, Drug: Ertugliflozin 2 mg split into twice daily, Drug: PlaceboPeriod 1: Ertu 2 mg in the AM and Pbo in the PM for 1 day. Period 2: Ertu 1 mg in the AM and Ertu 1 mg in the PM for 1 day. There was a >= 7 day washout period between Period 1 and Period 2.
Cohort 1: Ertu 1 mg/Ertu 1 mg→Ertu 2 mg/Pbo	Experimental	Drug: Ertugliflozin 2 mg single dose, Drug: Ertugliflozin 2 mg split into twice daily, Drug: PlaceboPeriod 1: Ertu 1 mg in the AM and Ertu 1 mg in the PM for 1 day. Period 2: Ertu 2 mg in the AM and Pbo in the PM for 1 day. There was a >= 7 day washout period between Period 1 and Period 2.
Cohort 2: Ertu 4 mg/Pbo→Ertu 2 mg/Ertu 2 mg	Experimental	Drug: Ertugliflozin 4 mg single dose, Drug: Ertugliflozin 4 mg split into twice daily, Drug: PlaceboPeriod 1: Ertu 4 mg in the AM and Pbo in the PM for 1 day. Period 2: Ertu 2 mg in the AM and Ertu 2 mg in the PM for 1 day. There was a >= 7 day washout period between Period 1 and Period 2.
Cohort 2: Ertu 2 mg/Ertu 2 mg→Ertu 4 mg/Pbo	Experimental	Drug: Ertugliflozin 4 mg single dose, Drug: Ertugliflozin 4 mg split into twice daily, Drug: PlaceboPeriod 1: Ertu 2 mg in the AM and Ertu 2 mg in the PM for 1 day. Period 2: Ertu 4 mg in the AM and Pbo in the PM for 1 day. There was a >= 7 day washout period between Period 1 and Period 2.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Participants with type 2 diabetes mellitus, either treatment-naïve or on up to 2 acceptable oral anti-diabetes drugs for at least 8-weeks prior to study.

Key exclusion criteria (1 listed)

Participants with type 1 diabetes mellitus, participants with stroke, unstable angina, heart attack in last 6-months, uncontrolled blood pressure.

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
Ertugliflozin 2 mg single doseErtugliflozin 2 mg dose (two 1 mg strength tablets), administered as a single dose	Drug	Cohort 1: Ertu 1 mg/Ertu 1 mg→Ertu 2 mg/Pbo, Cohort 1: Ertu 2 mg/Placebo (Pbo)→Ertu 1 mg/Ertu 1 mg
Ertugliflozin 2 mg split into twice dailyErtugliflozin 1 mg dose (1 mg strength tablet) administered twice daily x 1 day	Drug	Cohort 1: Ertu 1 mg/Ertu 1 mg→Ertu 2 mg/Pbo, Cohort 1: Ertu 2 mg/Placebo (Pbo)→Ertu 1 mg/Ertu 1 mg
Ertugliflozin 4 mg single doseErtugliflozin 4 mg dose (four 1 mg strength tablets), administered as a single dose	Drug	Cohort 2: Ertu 2 mg/Ertu 2 mg→Ertu 4 mg/Pbo, Cohort 2: Ertu 4 mg/Pbo→Ertu 2 mg/Ertu 2 mg
Ertugliflozin 4 mg split into twice dailyErtugliflozin 2 mg dose (two 1 mg strength tablets) administered twice daily x 1 day	Drug	Cohort 2: Ertu 2 mg/Ertu 2 mg→Ertu 4 mg/Pbo, Cohort 2: Ertu 4 mg/Pbo→Ertu 2 mg/Ertu 2 mg
PlaceboPlacebo to ertugliflozin administered as a single dose	Drug	Cohort 1: Ertu 1 mg/Ertu 1 mg→Ertu 2 mg/Pbo, Cohort 1: Ertu 2 mg/Placebo (Pbo)→Ertu 1 mg/Ertu 1 mg, Cohort 2: Ertu 2 mg/Ertu 2 mg→Ertu 4 mg/Pbo, Cohort 2: Ertu 4 mg/Pbo→Ertu 2 mg/Ertu 2 mg

Primary outcome

Cumulative Urinary Glucose Excretion Over 0 to 24 Hours
Time frame: 0 to 24 hours after the morning dose
Urine for analysis of glucose was collected at prespecified intervals. Each participant emptied his/her bladder just before dosing, and the collection started after the morning dose (collection times: 0-4 hours, 4-8 hours, 8-12 hours, and 12-24 hours after the morning dose). The average amount of urinary glucose excreted from 0 to 24 hours after the morning dose is presented in the table below.
Urinary Glucose Excretion by Time Period
Time frame: At 0-4 hrs, 4-8 hrs, 8-12 hrs, and 12-24 hrs after the AM dose (up to 24 hours)
Urine for analysis of glucose was collected at prespecified intervals. Each participant emptied his/her bladder just before dosing, and the collection started after the morning dose (collection times: 0-4 hours, 4-8 hours, 8-12 hours, and 12-24 hours after the morning dose). The average amount of urinary glucose excreted during the pre-specified time frame is presented in the table below.
24-hour Weighted Mean Plasma Glucose
Time frame: Up to 24 hours
Blood was collected during each treatment period at pre-dose (fasted) on Day 1 (Hour 0) and post-dose (fed) on Day 1 at 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 12.5, 13, 14, 15, 16, 18, and 24 hours.
Weighted Mean Postprandial Plasma Glucose
Time frame: At 0-5 hours, 5-12 hrs, and 12-18 hrs after the morning dose (up to 18 hours)
The weighted mean postprandial glucose over the specified intervals were analyzed by cohort.
Fasting Plasma Glucose
Time frame: Up to 24 hours
Blood samples were to be collected following a fast from all food and drink (except water) for at least 8 hours. Fasting Plasma Glucose was collected as part of the assessment of weighted mean 24-hour plasma glucose. As such, it was not specified as an endpoint in the Statistical Analysis Plan and was not analyzed or summarized separately.
Fasting C-peptide
Time frame: Up to 24 hours (0 and 24 hours)
The fasting c-peptide was analyzed by cohort using a mixed-effects model with sequence, period, and treatment as fixed effects and participant within sequence as a random effect.
Number of Participants Experiencing an Adverse Event
Time frame: Up to 16 days
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a product or medical device. The table below includes all data collected since the first dose of study drug.
Number of Participants Discontinuing Study Drug Due to an Adverse Event
Time frame: Up to 8 days (Day 1 in each dosing period)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a product or medical device. The table below includes all data collected since the first dose of study drug. Data include participants discontinued due to adverse events, participants with dose reduced or temporary discontinuation due to adverse events.
Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUClast) for Ertugliflozin
Time frame: 0 predose, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 18, 24 hours postdose
Pharmacokinetic (PK) parameter of AUClast for study drug. Actual sample collection times (relative to the AM dose) were used for the pharmacokinetic analysis.
Maximum Plasma Concentration (Cmax) of Ertugliflozin
Time frame: 0 predose, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 18, 24 hours postdose
PK parameter of Cmax for study drug. Actual sample collection times (relative to the AM dose) were used for the pharmacokinetic analysis.
Time Taken to Reach the Maximum Observed Plasma Concentration (Tmax) of Ertugliflozin
Time frame: 0 predose, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 18, 24 hours postdose
PK parameter of Tmax for study drug. Actual sample collection times (relative to the AM dose) were used for the pharmacokinetic analysis.

Results and safety

Results posted to the registry on 7 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: Ertu 2 mg/Pbo→Ertu 1 mg/Ertu 1 mg	13	12
Cohort 1: Ertu 1 mg/Ertu 1 mg→Ertu 2 mg/Pbo	13	13
Cohort 2: Ertu 4 mg/Pbo→Ertu 2 mg/Ertu 2 mg	13	13
Cohort 2: Ertu 2 mg/Ertu 2 mg→Ertu 4 mg/P	13	13

Primary outcome: Cumulative Urinary Glucose Excretion Over 0 to 24 Hours

Time frame: 0 to 24 hours after the morning dose. Least squares mean (90% Confidence Interval). Unit: Grams

Measure	Cohort 1: Ertugliflozin 1 mg Twice Daily n = 25	Cohort 1: Ertugliflozin 2 mg Once Daily n = 25	Cohort 2: Ertugliflozin 2 mg Twice Daily n = 24	Cohort 2: Ertugliflozin 4 mg Once Daily n = 24
Value	69.45 (9.08)	70.43 (9.08)	78.29 (9.77)	80.54 (9.81)

Population analysed: Analysis population included randomized participants who received assigned dose and had urine collection during all of the collection time frames between 0 and 24 hours following the morning dose.

Primary outcome: Urinary Glucose Excretion by Time Period

Time frame: At 0-4 hrs, 4-8 hrs, 8-12 hrs, and 12-24 hrs after the AM dose (up to 24 hours). Mean (Standard Deviation). Unit: Grams

Measure	Cohort 1: Ertugliflozin 1 mg Twice Daily n = 25	Cohort 1: Ertugliflozin 2 mg Once Daily n = 26	Cohort 2: Ertugliflozin 2 mg Twice Daily n = 25	Cohort 2: Ertugliflozin 4 mg Once Daily n = 26
0 to 4 hours post dose	12.88 (14.66)	14.03 (11.63)	14.66 (11.81)	16.34 (10.16)
4 to 8 hours post dose	15.42 (12.00)	17.87 (12.60)	16.97 (11.64)	19.78 (14.02)
8 to 12 hours post dose	14.47 (8.84)	11.99 (7.70)	14.30 (10.52)	12.91 (6.93)
12 to 24 hours post dose	26.76 (20.10)	26.31 (21.11)	31.47 (22.71)	32.94 (21.08)

Population analysed: Analysis population included randomized participants who received assigned dose and had urine collection during the specific time frame.

Primary outcome: 24-hour Weighted Mean Plasma Glucose

Time frame: Up to 24 hours. Mean (Standard Deviation). Unit: mg/dL

Measure	Cohort 1: Ertugliflozin 1 mg Twice Daily n = 23	Cohort 1: Ertugliflozin 2 mg Once Daily n = 25	Cohort 2: Ertugliflozin 2 mg Twice Daily n = 23	Cohort 2: Ertugliflozin 4 mg Once Daily n = 24
Value	173.6 (26.94)	175.7 (29.88)	169.1 (35.91)	170.4 (41.26)

Population analysed: Analysis population included randomized participants who received study drug and had mean plasma glucose measurements during all of the specific collection time frames.

Primary outcome: Weighted Mean Postprandial Plasma Glucose

Time frame: At 0-5 hours, 5-12 hrs, and 12-18 hrs after the morning dose (up to 18 hours). Mean (Standard Deviation). Unit: mg/dL

Measure	Cohort 1: Ertugliflozin 1 mg Twice Daily n = 25	Cohort 1: Ertugliflozin 2 mg Once Daily n = 26	Cohort 2: Ertugliflozin 2 mg Twice Daily n = 25	Cohort 2: Ertugliflozin 4 mg Once Daily n = 25
0 to 5 hours	200.1 (38.27)	187.2 (41.37)	194.1 (46.87)	189.9 (53.17)
5 to 12 hours	159.4 (25.76)	159.8 (28.46)	160.5 (42.14)	161.5 (40.70)
12 to 18 hours	180.7 (35.98)	190.7 (35.38)	182.6 (40.79)	181.9 (40.79)

Population analysed: Analysis population included randomized participants who received assigned dose and had postprandial plasma glucose measurements during the specific time frame.

Adverse events

Time frame: Up to 16 days (including 7-day follow-up for each period). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: Ertugliflozin 1 mg Twice Daily	0 of 25 (0%)	5 of 25 (20%)	0 of 25
Cohort 1: Ertugliflozin 2 mg Once Daily	0 of 26 (0%)	8 of 26 (30.8%)	0 of 26
Cohort 2: Ertugliflozin 2 mg Twice Daily	0 of 26 (0%)	3 of 26 (11.5%)	0 of 26
Cohort 2: Ertugliflozin 4 mg Once Daily	0 of 26 (0%)	5 of 26 (19.2%)	0 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 30802200Dawra VK, Liang Y, Shi H, Bass A, Hickman A, Terra SG, Zhou S, Cutler D, Sahasrabudhe V. A PK/PD study comparing twice-daily to once-daily dosing regimens of ertugliflozin in healthy subjects . Int J Clin Pharmacol Ther. 2019 Apr;57(4):207-216. doi: 10.5414/CP203343.
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?

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 1 inclusion and 1 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 21 Nov 2019. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 7 Nov 2018). 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?

Cumulative Urinary Glucose Excretion Over 0 to 24 Hours (time frame: 0 to 24 hours after the morning dose). The study lists 11 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 NCT01054300, 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 21 Nov 2019.