Type 2 Diabetes MellitusPhase 3NCT01958671

A Study of the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Participants With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise (MK-8835-003, VERTIS MONO)

A Phase 3 study testing Ertugliflozin 5 mg, Ertugliflozin 10 mg and Metformin in people with Type 2 Diabetes Mellitus, 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Ertugliflozin 5 mg, Ertugliflozin 10 mg and Metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 461 participants
Where: No sites listed yet
Study dates: 9 Oct 2013to 28 Jul 2016
Phase: Phase 3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of T2DM in accordance to American Diabetes Association guidelines
Participants with no prior allowable oral anti-hyperglycemic agents (AHA) for at least 8 weeks prior to study participation or participants on a single allowable oral AHA at the start of study participation
Participants on a single allowable AHA must be willing to discontinue this medication at the Screening Visit (S2) and remain off this medication for the duration of the trial. Allowable oral AHAs for discontinuation are metformin, sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, glinides or alpha-glucosidase inhibitors.

Who cannot join

History of myocardial infarction, unstable angina, arterial revascularization, stroke, transient ischemic attack, or New York Heart Association (NYHA) functional class III-IV heart failure within 3 months of study participation
A clinically significant electrocardiogram abnormality
A history of malignancy ≤5 years prior to study participation, except for adequately treated basal or squamous cell skin cancer or in situ cervical cancer
A known hypersensitivity or intolerance to any sodium-glucose co-transporter 2 (SGLT2) inhibitor or metformin
On a blood pressure or lipid altering medication that have not been on a stable dose for at least 4 weeks prior to study participation
A surgical procedure within 4 weeks prior to study participation or planned major surgery during the trial
Donation of blood or blood products within 6 weeks of study participation or plans to donate blood or blood products at any time during the trial
Pregnant or breast-feeding, or is expecting to conceive during the trial, including 14 days following the last dose of study drug

About this study

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, 26-week Multicenter Study With a 26-Week Extension to Evaluate the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise

This trial will evaluate the efficacy and safety of ertugliflozin monotherapy in the treatment of participants with type 2 diabetes mellitus (T2DM) and inadequate glycemic control on diet and exercise. This trial consists of a run-in period of 3 to 11 weeks, a 26-week placebo-controlled treatment period (Phase A), and a 26-week active treatment period (Phase B). The primary hypotheses of the trial are that at Week 26, the mean reduction from baseline in hemoglobin A1c (A1C) for 15 mg ertugliflozin is greater than that for placebo and the mean reduction from baseline in A1C for 5 mg ertugliflozin is greater than that for placebo.

Conditions: Type 2 Diabetes Mellitus
Being tested: Ertugliflozin 5 mg, Ertugliflozin 10 mg, Placebo to Ertugliflozin, Metformin, Placebo to Metformin
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 5 mgDrug
Also called MK-8835, PF-04971729
One tablet taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B).
Ertugliflozin 10 mgDrug
Also called MK-8835, PF-04971729
One tablet taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B).
Placebo to ErtugliflozinDrug
One placebo tablet matching the ertugliflozin 5 mg tablet and/or 1 placebo tablet matching the ertugliflozin 10 mg tablet per day taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B).
MetforminDrug
Also called Glucophage XR, Carbophage SR, Riomet, Fortamet, Glumetza, Obimet, Gluformin, Dianben, Diabex, Diaformin, Siofor and Metfogamma.
500 mg (1 tablet) in the morning and 500 mg (1 tablet) in the evening for 2 weeks, 1000 mg (2 tablets 500 mg) in the morning and 500 mg (1 tablet) in the evening for 2 weeks and 1000 mg (2 tablets 500 mg) in the morning and 1000 mg (2 tablets 500 mg) in the evening, thereafter.
Placebo to MetforminDrug
1 tablet in the morning and 1 tablet in the evening for 2 weeks, 2 tablets in the morning and 1 tablet in the evening for 2 weeks and 2 tablets in the morning and 2 tablets in the evening, thereafter.
GlimepirideDrug
Dosing and titration of glimepiride as rescue therapy was determined by the investigator.

Study groups in NCT01958671
Study group	Role	What they receive
Ertugliflozin 5 mg/Ertugliflozin 5 mg	Experimental	Phase A: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride. Receives: Drug: Ertugliflozin 5 mg; Drug: Placebo to Ertugliflozin; Drug: Metformin; Drug: Placebo to Metformin; Drug: Glimepiride
Ertugliflozin 15 mg/Ertugliflozin 15 mg	Experimental	Phase A: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride. Receives: Drug: Ertugliflozin 5 mg; Drug: Ertugliflozin 10 mg; Drug: Metformin; Drug: Placebo to Metformin; Drug: Glimepiride
Placebo/Metformin	Other	Phase A: Placebo to ertugliflozin administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Participants not rescued with open-label metformin in Phase A will also receive blinded metformin up to twice daily for 26 weeks in addition to placebo. Participants rescued with metformin in Phase A will continue to receive open-label metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride. Receives: Drug: Placebo to Ertugliflozin; Drug: Metformin; Drug: Glimepiride

What is being measured

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

Change From Baseline In A1C at Week 26
A1C is measured as percent. The change from baseline is the Week 26 A1C percent minus the Week 0 A1C percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.
Measured: Baseline and Week 26
Percentage of Participants Experiencing An Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Data presented include data following the initiation of rescue therapy.
Measured: Up to 54 weeks (including 2 weeks following last dose)
Percentage of Participants Discontinuing Study Treatment Due to an AE
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Data presented include data following the initiation of rescue therapy.
Measured: Up to 52 weeks

Secondary outcomes (9)

Change From Baseline in FPG at Week 26
The change from baseline is the Week 26 FPG minus the Week 0 FPG. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of glycemic rescue therapy.
Measured: Baseline and Week 26
Change From Baseline in Body Weight at Week 26
The change from baseline is the Week 26 body weight minus the Week 0 body weight. Data presented exclude data following the initiation of rescue therapy.
Measured: Baseline and Week 26
Percentage of Participants With A1C <7% (<53 mmol/Mol) at Week 26
A1C is measured as percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.
Measured: Week 26
Baseline 2-hour Post-prandial Glucose (2-hr PPG) Level
Laboratory measurements were performed 120 minutes following the start of the administration of the meal for the Mixed Meal Tolerance Test (MMTT). Change from baseline in 2-hr PPG level at Week 26 data are presented in the following outcome measure.
Measured: Baseline
Change From Baseline in 2-hr PPG at Week 26
The change from baseline is the Week 26 2-hr PPG minus the Week 0 2-hr PPG. Laboratory measurements were performed 120 minutes following the start of the administration of the meal for the MMTT. Data presented exclude data following the initiation of rescue therapy.
Measured: Baseline and Week 26
Baseline Sitting Systolic Blood Pressure (SBP)
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. Change from baseline in SBP at Week 26 data are presented in the following outcome measure.
Measured: Baseline
Change From Baseline in SBP at Week 26
The change from baseline is the Week 26 SBP minus the Week 0 SBP. Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. Data presented exclude data following the initiation of rescue therapy.
Measured: Baseline and Week 26
Baseline Sitting Diastolic Blood Pressure (DBP)
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. Change from baseline in DBP at Week 26 data are presented in the following outcome measure.
Measured: Baseline
Change From Baseline in DBP at Week 26
The change from baseline is the Week 26 DBP minus the Week 0 DBP. Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. Data presented exclude data following the initiation of rescue therapy.
Measured: Baseline and Week 26

Timeline

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

9 Oct 201328 Jul 2016

First posted9 Oct 2013 (estimated)
Study start9 Oct 2013
Primary completion28 Jul 2016
Study completion28 Jul 2016

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 (10)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 461 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01958671
Sponsor's protocol ID: 8835-003
Other IDs: 2013-002519-90, B1521022
Status last verified: Jul 2017
First submitted: 7 Oct 2013
Last updated: 29 Sep 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Terra SG, Focht K, Davies M, Frias J, Derosa G, Darekar A, Golm G, Johnson J, Saur D, Lauring B, Dagogo-Jack S. Phase III, efficacy and safety study of ertugliflozin monotherapy in people with type 2 diabetes mellitus inadequately controlled with diet and exercise alone. Diabetes Obes Metab. 2017 May;19(5):721-728. doi: 10.1111/dom.12888. Epub 2017 Feb 22.
PubMed 28116776
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
Gallo S, Raji A, Calle RA, Pong A, Meyer C. The effects of ertugliflozin on beta-cell function: Pooled analysis from four phase 3 randomized controlled studies. Diabetes Obes Metab. 2020 Dec;22(12):2267-2275. doi: 10.1111/dom.14149. Epub 2020 Aug 27.
PubMed 32700393
Gallo S, Calle RA, Terra SG, Pong A, Tarasenko L, Raji A. Effects of Ertugliflozin on Liver Enzymes in Patients with Type 2 Diabetes: A Post-Hoc Pooled Analysis of Phase 3 Trials. Diabetes Ther. 2020 Aug;11(8):1849-1860. doi: 10.1007/s13300-020-00867-1. Epub 2020 Jul 9.
PubMed 32648108
Patel S, Hickman A, Frederich R, Johnson S, Huyck S, Mancuso JP, Gantz I, Terra SG. Safety of Ertugliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Seven Phase 3 Randomized Controlled Trials. Diabetes Ther. 2020 Jun;11(6):1347-1367. doi: 10.1007/s13300-020-00803-3. Epub 2020 May 5.
PubMed 32372382
Liu J, Tarasenko L, Pong A, Huyck S, Wu L, Patel S, Hickman A, Mancuso JP, Gantz I, Terra SG. Efficacy and safety of ertugliflozin across racial groups in patients with type 2 diabetes mellitus. Curr Med Res Opin. 2020 Aug;36(8):1277-1284. doi: 10.1080/03007995.2020.1760228. Epub 2020 May 13.
PubMed 32324082
Liu J, Tarasenko L, Pong A, Huyck S, Patel S, Hickman A, Mancuso JP, Ellison MC, Gantz I, Terra SG. Efficacy and safety of ertugliflozin in Hispanic/Latino patients with type 2 diabetes mellitus. Curr Med Res Opin. 2020 Jul;36(7):1097-1106. doi: 10.1080/03007995.2020.1760227. Epub 2020 May 13.
PubMed 32324065
Liu J, Patel S, Cater NB, Wu L, Huyck S, Terra SG, Hickman A, Darekar A, Pong A, Gantz I. Efficacy and safety of ertugliflozin in East/Southeast Asian patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2020 Apr;22(4):574-582. doi: 10.1111/dom.13931. Epub 2020 Jan 3.
PubMed 31797522
Liu J, Pong A, Gallo S, Darekar A, Terra SG. Effect of ertugliflozin on blood pressure in patients with type 2 diabetes mellitus: a post hoc pooled analysis of randomized controlled trials. Cardiovasc Diabetol. 2019 May 7;18(1):59. doi: 10.1186/s12933-019-0856-7.
PubMed 31064361
Aronson R, Frias J, Goldman A, Darekar A, Lauring B, Terra SG. Long-term efficacy and safety of ertugliflozin monotherapy in patients with inadequately controlled T2DM despite diet and exercise: VERTIS MONO extension study. Diabetes Obes Metab. 2018 Jun;20(6):1453-1460. doi: 10.1111/dom.13251. Epub 2018 Feb 23.
PubMed 29419917

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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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, 26-week Multicenter Study With a 26-Week Extension to Evaluate the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise
ClinicalTrials.gov ID: NCT01958671
Acronym / sponsor ID: 8835-003
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 461 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: 9 Oct 2013 (actual)
Primary completion: 28 Jul 2016 (actual)
Study completion: 28 Jul 2016 (actual)
First posted: 9 Oct 2013 (estimated)
Results: Posted 29 Sep 2017

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Ertugliflozin 5 mg/Ertugliflozin 5 mg	Experimental	Drug: Ertugliflozin 5 mg, Drug: Placebo to Ertugliflozin, Drug: Metformin, Drug: Placebo to Metformin, Drug: GlimepiridePhase A: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
Ertugliflozin 15 mg/Ertugliflozin 15 mg	Experimental	Drug: Ertugliflozin 5 mg, Drug: Ertugliflozin 10 mg, Drug: Metformin, Drug: Placebo to Metformin, Drug: GlimepiridePhase A: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.
Placebo/Metformin	Other	Drug: Placebo to Ertugliflozin, Drug: Metformin, Drug: GlimepiridePhase A: Placebo to ertugliflozin administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Participants not rescued with open-label metformin in Phase A will also receive blinded metformin up to twice daily for 26 weeks in addition to placebo. Participants rescued with metformin in Phase A will continue to receive open-label metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.

Who may qualify

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

Key inclusion criteria (3 listed)

Diagnosis of T2DM in accordance to American Diabetes Association guidelines
Participants with no prior allowable oral anti-hyperglycemic agents (AHA) for at least 8 weeks prior to study participation or participants on a single allowable oral AHA at the start of study participation
Participants on a single allowable AHA must be willing to discontinue this medication at the Screening Visit (S2) and remain off this medication for the duration of the trial. Allowable oral AHAs for discontinuation are metformin, sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, glinides or alpha-glucosidase inhibitors.

Key exclusion criteria (8 listed)

History of myocardial infarction, unstable angina, arterial revascularization, stroke, transient ischemic attack, or New York Heart Association (NYHA) functional class III-IV heart failure within 3 months of study participation
A clinically significant electrocardiogram abnormality
A history of malignancy ≤5 years prior to study participation, except for adequately treated basal or squamous cell skin cancer or in situ cervical cancer
A known hypersensitivity or intolerance to any sodium-glucose co-transporter 2 (SGLT2) inhibitor or metformin
On a blood pressure or lipid altering medication that have not been on a stable dose for at least 4 weeks prior to study participation

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 5 mgAlso: MK-8835, PF-04971729One tablet taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B).	Drug	Ertugliflozin 15 mg/Ertugliflozin 15 mg, Ertugliflozin 5 mg/Ertugliflozin 5 mg
Ertugliflozin 10 mgAlso: MK-8835, PF-04971729One tablet taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B).	Drug	Ertugliflozin 15 mg/Ertugliflozin 15 mg
Placebo to ErtugliflozinOne placebo tablet matching the ertugliflozin 5 mg tablet and/or 1 placebo tablet matching the ertugliflozin 10 mg tablet per day taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B).	Drug	Ertugliflozin 5 mg/Ertugliflozin 5 mg, Placebo/Metformin
MetforminAlso: Glucophage XR, Carbophage SR, Riomet, Fortamet, Glumetza, Obimet, Gluformin, Dianben, Diabex, Diaformin, Siofor and Metfogamma.500 mg (1 tablet) in the morning and 500 mg (1 tablet) in the evening for 2 weeks, 1000 mg (2 tablets 500 mg) in the morning and 500 mg (1 tablet) in the evening for 2 weeks and 1000 mg (2 tablets 500 mg) in the morning and 1000 mg (2 tablets 500 mg) in the evening, thereafter.	Drug	Ertugliflozin 15 mg/Ertugliflozin 15 mg, Ertugliflozin 5 mg/Ertugliflozin 5 mg, Placebo/Metformin
Placebo to Metformin1 tablet in the morning and 1 tablet in the evening for 2 weeks, 2 tablets in the morning and 1 tablet in the evening for 2 weeks and 2 tablets in the morning and 2 tablets in the evening, thereafter.	Drug	Ertugliflozin 15 mg/Ertugliflozin 15 mg, Ertugliflozin 5 mg/Ertugliflozin 5 mg
GlimepirideDosing and titration of glimepiride as rescue therapy was determined by the investigator.	Drug	Ertugliflozin 15 mg/Ertugliflozin 15 mg, Ertugliflozin 5 mg/Ertugliflozin 5 mg, Placebo/Metformin

Primary outcome

Change From Baseline In A1C at Week 26
Time frame: Baseline and Week 26
A1C is measured as percent. The change from baseline is the Week 26 A1C percent minus the Week 0 A1C percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.
Percentage of Participants Experiencing An Adverse Event (AE)
Time frame: Up to 54 weeks (including 2 weeks following last dose)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Data presented include data following the initiation of rescue therapy.
Percentage of Participants Discontinuing Study Treatment Due to an AE
Time frame: Up to 52 weeks
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Data presented include data following the initiation of rescue therapy.

9 secondary outcomes

Change From Baseline in FPG at Week 26
Time frame: Baseline and Week 26
Change From Baseline in Body Weight at Week 26
Time frame: Baseline and Week 26
Percentage of Participants With A1C <7% (<53 mmol/Mol) at Week 26
Time frame: Week 26
Baseline 2-hour Post-prandial Glucose (2-hr PPG) Level
Time frame: Baseline
Change From Baseline in 2-hr PPG at Week 26
Time frame: Baseline and Week 26
Baseline Sitting Systolic Blood Pressure (SBP)
Time frame: Baseline
Change From Baseline in SBP at Week 26
Time frame: Baseline and Week 26
Baseline Sitting Diastolic Blood Pressure (DBP)
Time frame: Baseline
Change From Baseline in DBP at Week 26
Time frame: Baseline and Week 26

Results and safety

Results posted to the registry on 29 Sep 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ertugliflozin 5 mg/Ertugliflozin 5 mg	156	137
Ertugliflozin 15 mg/Ertugliflozin 15 mg	152	128
Placebo/Metformin	153	121

Primary outcome: Change From Baseline In A1C at Week 26

Time frame: Baseline and Week 26. Least squares mean (95% Confidence Interval). Unit: Percent

Measure	Ertugliflozin 5 mg n = 156	Ertugliflozin 15 mg n = 151	Placebo n = 153
Value	-0.79 (-0.95 to -0.63)	-0.96 (-1.12 to -0.80)	0.20 (0.02 to 0.37)

Ertugliflozin 5 mg vs Placebo: Difference in least squares means: -0.99 (95% CI -1.22 to -0.76), p <0.001, Constrained longitudinal data analysis
Ertugliflozin 15 mg vs Placebo: Difference in least squares means: -1.16 (95% CI -1.39 to -0.93), p <0.001, Constrained longitudinal data analysis

Population analysed: Analysis population consisted of all randomized participants who received at least 1 dose of study treatment and had a baseline A1C measurement or at least 1 post-randomization A1C measurement subsequent to at least 1 dose of study treatment.

Primary outcome: Percentage of Participants Experiencing An Adverse Event (AE)

Time frame: Up to 54 weeks (including 2 weeks following last dose). Number. Unit: Percentage of participants

Measure	Ertugliflozin 5 mg/Ertugliflozin 5 mg n = 156	Ertugliflozin 15 mg/Ertugliflozin 15 mg n = 152	Placebo/Metformin n = 153
Value	64.1	62.5	66.7

Ertugliflozin 5 mg/Ertugliflozin 5 mg vs Placebo/Metformin: Difference in percentage: -2.6 (95% CI -13.1 to 8.1)
Ertugliflozin 15 mg/Ertugliflozin 15 mg vs Placebo/Metformin: Difference in percentage: -4.2 (95% CI -14.8 to 6.6)

Population analysed: Analysis population consisted of all randomized participants who received at least 1 dose of study treatment. Participants were classified according to randomized treatment.

Primary outcome: Percentage of Participants Discontinuing Study Treatment Due to an AE

Time frame: Up to 52 weeks. Number. Unit: Percentage of participants

Measure	Ertugliflozin 5 mg/Ertugliflozin 5 mg n = 156	Ertugliflozin 15 mg/Ertugliflozin 15 mg n = 152	Placebo/Metformin n = 153
Value	4.5	3.9	6.5

Ertugliflozin 5 mg/Ertugliflozin 5 mg vs Placebo/Metformin: Difference in percentage: -2.0 (95% CI -7.7 to 3.3)
Ertugliflozin 15 mg/Ertugliflozin 15 mg vs Placebo/Metformin: Difference in percentage: -2.6 (95% CI -8.2 to 2.7)

Population analysed: Analysis population consisted of all randomized participants who received at least 1 dose of study treatment. Participants were classified according to randomized treatment.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 54 weeks (+/- 3 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ertugliflozin 5 mg/Ertugliflozin 5 mg	11 of 156 (7.1%)	50 of 156 (32.1%)	Not reported
Ertugliflozin 15 mg/Ertugliflozin 15 mg	6 of 152 (3.9%)	48 of 152 (31.6%)	Not reported
Placebo/Metformin	8 of 153 (5.2%)	68 of 153 (44.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28116776Terra SG, Focht K, Davies M, Frias J, Derosa G, Darekar A, Golm G, Johnson J, Saur D, Lauring B, Dagogo-Jack S. Phase III, efficacy and safety study of ertugliflozin monotherapy in people with type 2 diabetes mellitus inadequately controlled with diet and exercise alone. Diabetes Obes Metab. 2017 May;19(5):721-728. doi: 10.1111/dom.12888. Epub 2017 Feb 22.
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.
Derived from this study: PubMed 32700393Gallo S, Raji A, Calle RA, Pong A, Meyer C. The effects of ertugliflozin on beta-cell function: Pooled analysis from four phase 3 randomized controlled studies. Diabetes Obes Metab. 2020 Dec;22(12):2267-2275. doi: 10.1111/dom.14149. Epub 2020 Aug 27.
Derived from this study: PubMed 32648108Gallo S, Calle RA, Terra SG, Pong A, Tarasenko L, Raji A. Effects of Ertugliflozin on Liver Enzymes in Patients with Type 2 Diabetes: A Post-Hoc Pooled Analysis of Phase 3 Trials. Diabetes Ther. 2020 Aug;11(8):1849-1860. doi: 10.1007/s13300-020-00867-1. Epub 2020 Jul 9.
Derived from this study: PubMed 32372382Patel S, Hickman A, Frederich R, Johnson S, Huyck S, Mancuso JP, Gantz I, Terra SG. Safety of Ertugliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Seven Phase 3 Randomized Controlled Trials. Diabetes Ther. 2020 Jun;11(6):1347-1367. doi: 10.1007/s13300-020-00803-3. Epub 2020 May 5.
Derived from this study: PubMed 32324082Liu J, Tarasenko L, Pong A, Huyck S, Wu L, Patel S, Hickman A, Mancuso JP, Gantz I, Terra SG. Efficacy and safety of ertugliflozin across racial groups in patients with type 2 diabetes mellitus. Curr Med Res Opin. 2020 Aug;36(8):1277-1284. doi: 10.1080/03007995.2020.1760228. Epub 2020 May 13.
Derived from this study: PubMed 32324065Liu J, Tarasenko L, Pong A, Huyck S, Patel S, Hickman A, Mancuso JP, Ellison MC, Gantz I, Terra SG. Efficacy and safety of ertugliflozin in Hispanic/Latino patients with type 2 diabetes mellitus. Curr Med Res Opin. 2020 Jul;36(7):1097-1106. doi: 10.1080/03007995.2020.1760227. Epub 2020 May 13.
Derived from this study: PubMed 31797522Liu J, Patel S, Cater NB, Wu L, Huyck S, Terra SG, Hickman A, Darekar A, Pong A, Gantz I. Efficacy and safety of ertugliflozin in East/Southeast Asian patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2020 Apr;22(4):574-582. doi: 10.1111/dom.13931. Epub 2020 Jan 3.
Derived from this study: PubMed 31064361Liu J, Pong A, Gallo S, Darekar A, Terra SG. Effect of ertugliflozin on blood pressure in patients with type 2 diabetes mellitus: a post hoc pooled analysis of randomized controlled trials. Cardiovasc Diabetol. 2019 May 7;18(1):59. doi: 10.1186/s12933-019-0856-7.
Derived from this study: PubMed 29419917Aronson R, Frias J, Goldman A, Darekar A, Lauring B, Terra SG. Long-term efficacy and safety of ertugliflozin monotherapy in patients with inadequately controlled T2DM despite diet and exercise: VERTIS MONO extension study. Diabetes Obes Metab. 2018 Jun;20(6):1453-1460. doi: 10.1111/dom.13251. Epub 2018 Feb 23.

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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 3 study testing Ertugliflozin 5 mg, Ertugliflozin 10 mg and Metformin in people with Type 2 Diabetes Mellitus, 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 3 inclusion and 8 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 29 Sep 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 29 Sep 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?

Change From Baseline In A1C at Week 26 (time frame: Baseline and Week 26). The study lists 3 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 NCT01958671, which also lists 10 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 29 Sep 2017.