Type 2 Diabetes MellitusPhase 3NCT01986855

A Study of the Efficacy and Safety of Ertugliflozin in Participants With Type 2 Diabetes Mellitus With Stage 3 Chronic Kidney Disease Who Have Inadequate Glycemic Control on Antihyperglycemic Therapy (MK-8835-001)

A Phase 3 study testing Ertugliflozin 5 mg and Ertugliflozin 10 mg 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

Search all trials

Trial summary

Who is it for?: Ages 25 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Ertugliflozin 5 mg and Ertugliflozin 10 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 468 participants
Where: No sites listed yet
Study dates: 2 Dec 2013to 28 Sep 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 25 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of Type 2 diabetes mellitus in accordance with American Diabetes Association guidelines
Have Stage 3 chronic kidney disease
On stable diabetes therapy (diet/exercise therapy alone or anti-hyperglycemic agents [AHA] monotherapy or combination therapy) for at least 6 weeks prior to study participation OR on metformin (with or without diet/exercise therapy or other AHA therapy) and is willing to undergo a 10-week metformin wash-off period
Have an estimated glomerular filtration rate (eGFR) of ≥30 to <60 mL/min/1.73m^2
Body Mass Index (BMI) greater than or equal to 18.0 kg/m^2
Male, postmenopausal female or surgically sterile female
If a female of reproductive potential, agrees to remain abstinent or to use (or have their partner use) 2 acceptable combinations of birth control while participating in the trial and for 14 days after the last use of study drug.

Who cannot join

History of type 1 diabetes mellitus or a history of ketoacidosis
History of other specific types of diabetes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrine disorders, drug - or chemical-induced, and post-organ transplant)
History of nephrotic range proteinuria with hypoalbuminemia and edema
History of rapidly progressive glomerulonephritis, lupus nephritis, renal or systemic vasculitis, renal artery stenosis with renovascular hypertension, or ischemic nephropathy
History of familial renal glucosuria
History of renal dialysis or renal transplant or renal disease requiring treatment with any immunosuppressive agent

Show all 26Show fewer

A known hypersensitivity or intolerance to any (sodium-glucose co-transporter 2) SGLT2 inhibitor
On a weight-loss program or weight-loss medication or other medication associated with weight changes and is not weight stable
Has undergone bariatric surgery within the past 12 months
Has been treated with rosiglitazone or other SGLT2 inhibitors within 12 weeks of study participation
Has active, obstructive uropathy or indwelling urinary catheter
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 history of malignancy ≤5 years prior to study participation, except for adequately treated basal or squamous cell skin cancer or in situ cervical cancer
Known history of Human Immunodeficiency Virus (HIV)
Has blood dyscrasias or any disorders causing hemolysis or unstable red blood cells or any other clinically significant hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
A medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or active symptomatic gallbladder disease
Has any clinically significant malabsorption condition
If taking thyroid replacement therapy, has not been on a stable dose for at least 6 weeks prior to study participation
Has been previously randomized in a study with ertugliflozin
Has participated in other studies involving an investigational drug within 30 days prior or during study participation
Has undergone a surgical procedure within 6 weeks prior to or during study participation
Has a positive urine pregnancy test
Is pregnant or breast-feeding, or is planning to conceive during the trial, including 14 days following the last dose of study medication
Planning to undergo hormonal therapy in preparation to donate eggs during the trial, including 14 days following the last dose of study medication
Excessive consumption of alcoholic beverages or binge drinking
Has donated blood or blood products within 6 weeks of study participation or plans to donate blood or blood products at any time during the trial

About this study

Official title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) in Subjects With Type 2 Diabetes Mellitus With Stage 3 Chronic Kidney Disease Who Have Inadequate Glycemic Control on Background Antihyperglycemic Therapy

This study will evaluate the efficacy and safety of ertugliflozin (MK-8835/PF-04971729) in participants with Type 2 diabetes mellitus with Stage 3 Chronic Kidney Disease (CKD) who have inadequate glycemic control on background antihyperglycemic therapy. The duration of this trial will be up to 67 weeks. This study will consist of a 1-week Screening Period, a 10-week wash-off period from metformin, if needed, and a 2-week placebo run-in period, a 52-week double-blind treatment period, and a 14-day post-treatment follow-up period. The primary objective of this trial is to assess the hemoglobin A1C (A1C)-lowering efficacy of the addition of ertugliflozin compared to the addition of placebo with an underlying hypothesis that addition of treatment with ertugliflozin provides greater reduction in A1C compared to the addition of placebo; the primary objective will be tested for both 5-mg and 15-mg doses of ertugliflozin.

Read the detailed description

Participants who meet protocol-defined glycemic rescue criteria will be permitted to have an adjustment in the dose(s) of background antihyperglycemic agent (AHA) therapy or addition of new AHA therapy as directed by their investigator until the participant no longer meets the rescue criteria.

Conditions: Type 2 Diabetes Mellitus
Being tested: Ertugliflozin 5 mg, Placebo 5 mg, Ertugliflozin 10 mg, Placebo 10 mg
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
Ertugliflozin, oral, 5 mg tablet once daily for 52 weeks
Placebo 5 mgDrug
Placebo to ertugliflozin, oral, tablet, 5 mg tablet once daily for 52 weeks
Ertugliflozin 10 mgDrug
Also called MK-8835, PF-04971729
Ertugliflozin, oral, tablet, 10 mg tablet once daily for 52 weeks
Placebo 10 mgDrug
Placebo to ertugliflozin, oral, tablet, 10 mg tablet once daily for 52 weeks

Study groups in NCT01986855
Study group	Role	What they receive
Ertugliflozin (5 mg)	Experimental	Ertugliflozin, 5 mg, oral, one 5 mg ertugliflozin tablet and one placebo tablet, once daily for 52 weeks Receives: Drug: Ertugliflozin 5 mg; Drug: Placebo 10 mg
Ertugliflozin (15 mg)	Experimental	Ertugliflozin, 15 mg, oral, one 5 mg and one 10 mg tablet, once daily for 52 weeks Receives: Drug: Ertugliflozin 10 mg
Placebo	Placebo comparator	Matching placebo Receives: Drug: Placebo 5 mg; Drug: Placebo 10 mg

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 - Excluding Rescue Approach
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 26 A1C minus the Week 0 A1C. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.
Measured: Baseline and Week 26
Percentage of Participants Who Experienced an Adverse Event (AE)
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Measured: Up to 54 weeks
Percentage of Participants Who Discontinued Study Treatment Due to an AE
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Measured: Up to 52 weeks

Secondary outcomes (5)

Change From Baseline in A1C at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue Approach
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 26 A1C minus the Week 0 A1C. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.
Measured: Baseline and Week 26
Change From Baseline in Body Weight at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue Approach
This change from baseline reflects the Week 26 body weight minus the Week 0 body weight. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.
Measured: Baseline and Week 26
Change From Baseline in Sitting Systolic Blood Pressure at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue Approach
This change from baseline reflects the Week 26 sitting systolic blood pressure minus the Week 0 sitting systolic blood pressure. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.
Measured: Baseline and Week 26
Change From Baseline in FPG at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue Approach
This change from baseline reflects the Week 26 FPG minus the Week 0 FPG. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.
Measured: Baseline and Week 26
Percentage of Participants With A1C <7.0% (<53 mmol/Mol) at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue Approach
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.
Measured: Week 26

Timeline

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

2 Dec 201328 Sep 2016

First posted19 Nov 2013 (estimated)
Study start2 Dec 2013
Primary completion28 Sep 2016
Study completion28 Sep 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 (8)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: 468 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01986855
Sponsor's protocol ID: 8835-001
Other IDs: 2013-003587-31, B1521016
Status last verified: Aug 2018
First submitted: 12 Nov 2013
Last updated: 10 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Grunberger G, Camp S, Johnson J, Huyck S, Terra SG, Mancuso JP, Jiang ZW, Golm G, Engel SS, Lauring B. Ertugliflozin in Patients with Stage 3 Chronic Kidney Disease and Type 2 Diabetes Mellitus: The VERTIS RENAL Randomized Study. Diabetes Ther. 2018 Feb;9(1):49-66. doi: 10.1007/s13300-017-0337-5. Epub 2017 Nov 20.
PubMed 29159457
Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
PubMed 38770818
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, 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

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 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) in Subjects With Type 2 Diabetes Mellitus With Stage 3 Chronic Kidney Disease Who Have Inadequate Glycemic Control on Background Antihyperglycemic Therapy
ClinicalTrials.gov ID: NCT01986855
Acronym / sponsor ID: 8835-001
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 468 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: 2 Dec 2013 (actual)
Primary completion: 28 Sep 2016 (actual)
Study completion: 28 Sep 2016 (actual)
First posted: 19 Nov 2013 (estimated)
Results: Posted 4 Oct 2017

Clinical summary

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

Detailed description

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)	Experimental	Drug: Ertugliflozin 5 mg, Drug: Placebo 10 mgErtugliflozin, 5 mg, oral, one 5 mg ertugliflozin tablet and one placebo tablet, once daily for 52 weeks
Ertugliflozin (15 mg)	Experimental	Drug: Ertugliflozin 10 mgErtugliflozin, 15 mg, oral, one 5 mg and one 10 mg tablet, once daily for 52 weeks
Placebo	Placebo comparator	Drug: Placebo 5 mg, Drug: Placebo 10 mgMatching placebo

Who may qualify

Ages: 25 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Diagnosis of Type 2 diabetes mellitus in accordance with American Diabetes Association guidelines
Have Stage 3 chronic kidney disease
On stable diabetes therapy (diet/exercise therapy alone or anti-hyperglycemic agents [AHA] monotherapy or combination therapy) for at least 6 weeks prior to study participation OR on metformin (with or without diet/exercise therapy or other AHA therapy) and is willing to undergo a 10-week metformin wash-off period
Have an estimated glomerular filtration rate (eGFR) of ≥30 to <60 mL/min/1.73m^2
Body Mass Index (BMI) greater than or equal to 18.0 kg/m^2

Key exclusion criteria (26 listed)

History of type 1 diabetes mellitus or a history of ketoacidosis
History of other specific types of diabetes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrine disorders, drug - or chemical-induced, and post-organ transplant)
History of nephrotic range proteinuria with hypoalbuminemia and edema
History of rapidly progressive glomerulonephritis, lupus nephritis, renal or systemic vasculitis, renal artery stenosis with renovascular hypertension, or ischemic nephropathy
History of familial renal glucosuria

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-04971729Ertugliflozin, oral, 5 mg tablet once daily for 52 weeks	Drug	Ertugliflozin (5 mg)
Placebo 5 mgPlacebo to ertugliflozin, oral, tablet, 5 mg tablet once daily for 52 weeks	Drug	Placebo
Ertugliflozin 10 mgAlso: MK-8835, PF-04971729Ertugliflozin, oral, tablet, 10 mg tablet once daily for 52 weeks	Drug	Ertugliflozin (15 mg)
Placebo 10 mgPlacebo to ertugliflozin, oral, tablet, 10 mg tablet once daily for 52 weeks	Drug	Ertugliflozin (5 mg), Placebo

Primary outcome

Change From Baseline in A1C at Week 26 - Excluding Rescue Approach
Time frame: Baseline and Week 26
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 26 A1C minus the Week 0 A1C. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.
Percentage of Participants Who Experienced an Adverse Event (AE)
Time frame: Up to 54 weeks
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Percentage of Participants Who Discontinued Study Treatment Due to an AE
Time frame: Up to 52 weeks
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

5 secondary outcomes

Change From Baseline in A1C at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue Approach
Time frame: Baseline and Week 26
Change From Baseline in Body Weight at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue Approach
Time frame: Baseline and Week 26
Change From Baseline in Sitting Systolic Blood Pressure at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue Approach
Time frame: Baseline and Week 26
Change From Baseline in FPG at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue Approach
Time frame: Baseline and Week 26
Percentage of Participants With A1C <7.0% (<53 mmol/Mol) at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue Approach
Time frame: Week 26

Results and safety

Results posted to the registry on 4 Oct 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	158	145
Ertugliflozin 15 mg	156	142
Placebo	154	143

Primary outcome: Change From Baseline in A1C at Week 26 - Excluding Rescue Approach

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

Measure	Ertugliflozin 5 mg n = 158	Ertugliflozin 15 mg n = 155	Placebo n = 154
Value	-0.29 (-0.44 to -0.14)	-0.41 (-0.56 to -0.27)	-0.26 (-0.41 to -0.11)

Ertugliflozin 5 mg vs Placebo: Difference in the least squares means: -0.03 (95% CI -0.23 to 0.18), p = 0.807, Constrained longitudinal data analysis
Ertugliflozin 15 mg vs Placebo: Difference in the least squares means: -0.15 (95% CI -0.35 to 0.06), p = 0.155, Constrained longitudinal data analysis

Population analysed: The analysis population included all randomized participants who took at least 1 dose of study treatment and had at least 1 assessment at or after baseline for the change from baseline at Week 26 A1C endpoint.

Primary outcome: Percentage of Participants Who Experienced an Adverse Event (AE)

Time frame: Up to 54 weeks. Number. Unit: Percentage of participants

Measure	Ertugliflozin 5 mg n = 158	Ertugliflozin 15 mg n = 155	Placebo n = 154
Value	84.8	74.2	81.2

Ertugliflozin 5 mg vs Placebo: Difference in Percentages vs. Placebo: 3.6 (95% CI -4.8 to 12.1)
Ertugliflozin 15 mg vs Placebo: Difference in Percentages vs. Placebo: -7.0 (95% CI -16.3 to 2.3)

Population analysed: The analysis population included all randomized participants who received at least 1 dose of study treatment.

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

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

Measure	Ertugliflozin 5 mg n = 158	Ertugliflozin 15 mg n = 155	Placebo n = 154
Value	8.2	3.9	5.2

Ertugliflozin 5 mg vs Placebo: Difference in Percentages vs. Placebo: 3.0 (95% CI -2.7 to 9.0)
Ertugliflozin 15 mg vs Placebo: Difference in Percentages vs. Placebo: -1.3 (95% CI -6.5 to 3.7)

Population analysed: The analysis population included all randomized participants who received at least 1 dose of study treatment.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 54 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	24 of 154 (15.6%)	68 of 154 (44.2%)	Not reported
Ertugliflozin 5 mg	26 of 158 (16.5%)	82 of 158 (51.9%)	Not reported
Ertugliflozin 15 mg	30 of 155 (19.4%)	62 of 155 (40%)	Not reported

Limitations and caveats (from the sponsor): After unblinding, analysis of retained plasma samples revealed unreported metformin use by \~17% of participants. Neither dose nor frequency of the protocol-prohibited metformin use is known. This potentially confounds glycemic analyses.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 29159457Grunberger G, Camp S, Johnson J, Huyck S, Terra SG, Mancuso JP, Jiang ZW, Golm G, Engel SS, Lauring B. Ertugliflozin in Patients with Stage 3 Chronic Kidney Disease and Type 2 Diabetes Mellitus: The VERTIS RENAL Randomized Study. Diabetes Ther. 2018 Feb;9(1):49-66. doi: 10.1007/s13300-017-0337-5. Epub 2017 Nov 20.
Derived from this study: PubMed 38770818Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
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 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.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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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
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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 and Ertugliflozin 10 mg 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 7 inclusion and 26 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 10 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 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 4 Oct 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 - Excluding Rescue Approach (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 NCT01986855, which also lists 8 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 10 Sep 2018.