Type 2 Diabetes MellitusPhase 3NCT01999218

Ertugliflozin vs. Glimepiride in Type 2 Diabetes Mellitus (T2DM) Participants on Metformin (MK-8835-002)

A Phase 3 study testing Ertugliflozin 5 mg, Ertugliflozin 10 mg and Glimerpiride 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 18 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Ertugliflozin 5 mg, Ertugliflozin 10 mg and Glimerpiride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,326 participants
Where: No sites listed yet
Study dates: 16 Dec 2013to 18 Apr 2017
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
On metformin monotherapy or metformin in combination with a single allowable anti-hyperglycemic agent (AHA), DPP-4 inhibitors, meglitinides and AGIs are listed as allowable AHAs along with sulfonylureas prior to study participation.
Body Mass Index (BMI) ≥18.0 kg/m^2
Male or female not of reproductive potential
If a female of reproductive potential, agree 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 or presence of type 1 diabetes mellitus or a history of ketoacidosis
History of other specific types of diabetes (eg, genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant).
A known hypersensitivity or intolerance to any sodium-glucose co-transporter 2 (SGLT2) inhibitor
Use of the following prohibited therapeutic agents within 12 weeks of study participation: insulin, injectable anti-hyperglycemic agents, pioglitazone or rosiglitazone, another SGLT2 inhibitor, bromocriptine (Cycloset®), colesevelam (Welchol®), and any other non-approved anti-hyperglycemic therapy
Known hypersensitivity or intolerance to metformin or glimepiride
On a weight-loss program or medication or medication associated with weight changes and is not weight-stable (>=5% change in body weight in the last 6 months)

Show all 23Show fewer

History of bariatric surgery less than 12 months prior to study participation
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
Active, obstructive uropathy or an indwelling urinary catheter
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)
Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells
A medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C (assessed by medical history), primary biliary cirrhosis, or symptomatic gallbladder disease
Any clinically significant malabsorption condition
Being treated for hyperthyroidism, or on thyroid replacement therapy that has not been at a stable dose for at least 6 weeks prior to study participation
Previous randomization in a study with ertugliflozin
Participation in other studies involving investigational drug(s) within 30 days of study participation and/or during the pre-randomization period
A surgical procedure within 6 weeks prior to study participation or planned major surgery during the trial
A positive urine pregnancy test
Pregnant or breast-feeding, or expecting to conceive during the trial, including 14 days following the last dose of study drug
Undergoing hormonal therapy in preparation to donate eggs during the period of the trial, including 14 days following the last dose of study drug
Consumption of more than 2 alcoholic drinks per day or engages in binge drinking
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

About this study

Official title: A Phase III, Multicenter, Randomized, Double-Blind, Active-Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Ertugliflozin (MK-8835/PF-04971729) Compared With the Addition of Glimepiride in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin

This study will evaluate the efficacy and safety of the addition of ertugliflozin (MK-8835/PF-04971729) compared with the addition of glimepiride in participants with T2DM who have inadequate glycemic control on metformin. The primary hypothesis of this study is that after 52 weeks, the change from baseline in hemoglobin A1c (A1C) in participants treated with the addition of ertugliflozin 15 mg once daily is non-inferior compared with that in participants treated with the addition of glimepiride.

Read the detailed description

The duration of the trial will be up to approximately 122 weeks. This will include a 1-week screening period, an up to 13-week wash-off/titration/dose stabilization period, a 2-week placebo run-in period, a 104-week double-blind, active comparator-controlled treatment period, and a post-treatment telephone contact 14 days after the last dose of study drug.

Conditions: Type 2 Diabetes Mellitus
Being tested: Ertugliflozin 5 mg, Ertugliflozin 10 mg, Glimerpiride, Placebo to Ertugliflozin, Placebo to Glimepiride
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
Ertugliflozin, 5 mg, oral, once daily, from Day 1 to Week 104
Ertugliflozin 10 mgDrug
Also called MK-8355
Ertugliflozin, 10 mg, oral, once daily from Day 1 to Week 104.
GlimerpirideDrug
Glimepiride, oral tablets, initiated at 1 mg daily and titrated up to the maximum approved dose (8 mg daily based on the local country label) or maximum tolerated dose
Placebo to ErtugliflozinDrug
Matching placebo to ertugliflozin, 5 mg and/or 10 mg, oral, once daily, from Day 1 to Week 104
Placebo to GlimepirideDrug
Matching placebo to glimepiride, 1 mg or 2 mg, oral, once daily, from Day 1 to Week 104.
MetforminDrug
Participants are to remain on their stable doses of metformin (oral, >=1500 mg/day) while receiving blinded investigational product during the double-blind treatment period. Participants on metformin <1500 at screening are up-titrated to >= 1500 daily.
SitagliptinDrug
Open label, oral, once daily, rescue medication as required.

Study groups in NCT01999218
Study group	Role	What they receive
Ertugliflozin 5 mg	Experimental	Ertugliflozin 5 mg once daily (QD) from Day 1 to Week 104 Receives: Drug: Ertugliflozin 5 mg; Drug: Placebo to Ertugliflozin; Drug: Placebo to Glimepiride; Drug: Metformin; Drug: Sitagliptin
Ertugliflozin 15 mg	Experimental	Ertugliflozin 15 mg QD from Day 1 to Week 104 Receives: Drug: Ertugliflozin 5 mg; Drug: Ertugliflozin 10 mg; Drug: Placebo to Glimepiride; Drug: Metformin; Drug: Sitagliptin
Glimepiride up to 8 mg	Active comparator	Glimepiride to a maximum of 8 mg QD from Day 1 to Week 104 Receives: Drug: Glimerpiride; Drug: Placebo to Ertugliflozin; Drug: Metformin; Drug: Sitagliptin

What is being measured

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

Change From Baseline in Hemoglobin A1C (A1C) at Week 52: 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 (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 52 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication. The primary study objective was the MK-8835 15 mg vs. glimepiride comparison; the MK-8835 5mg vs glimerpiride comparison was a secondary study objective.
Measured: Baseline and Week 52
Percentage of Participants Experiencing An Adverse Event (AE) Up to Week 106
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 Week 106
Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 104
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 Week 104

Secondary outcomes (3)

Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 52: Excluding Rescue Approach
Symptomatic hypoglycemia was an event with clinical symptoms reported by the investigator as hypoglycemia (biochemical documentation not required). Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication.
Measured: Up to Week 52
Change From Baseline in Body Weight at Week 52 Excluding Rescue Approach
This change from baseline reflects the Week 52 body weight minus the Week 0 body weight. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication.
Measured: Baseline and Week 52
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 52 Excluding Rescue Approach
This change from baseline reflects the Week 52 SBP minus the Week 0 SBP. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication.
Measured: Baseline and Week 52

Timeline

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

16 Dec 201318 Apr 2017

First posted3 Dec 2013 (estimated)
Study start16 Dec 2013
Primary completion18 Apr 2017
Study completion18 Apr 2017

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: 1,326 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01999218
Sponsor's protocol ID: 8835-002
Other IDs: 2013-003582-34, B1521013
Status last verified: Mar 2019
First submitted: 25 Nov 2013
Last updated: 2 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Hollander P, Hill J, Johnson J, Wei Jiang Z, Golm G, Huyck S, Terra SG, Mancuso JP, Engel SS, Lauring B, Liu J. Results of VERTIS SU extension study: safety and efficacy of ertugliflozin treatment over 104 weeks compared to glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin. Curr Med Res Opin. 2019 Aug;35(8):1335-1343. doi: 10.1080/03007995.2019.1583450. Epub 2019 Mar 25.
PubMed 30760125
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
Cherney DZI, Heerspink HJL, Frederich R, Maldonado M, Liu J, Pong A, Xu ZJ, Patel S, Hickman A, Mancuso JP, Gantz I, Terra SG. Effects of ertugliflozin on renal function over 104 weeks of treatment: a post hoc analysis of two randomised controlled trials. Diabetologia. 2020 Jun;63(6):1128-1140. doi: 10.1007/s00125-020-05133-4. Epub 2020 Mar 31.
PubMed 32236732
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
Hollander P, Liu J, Hill J, Johnson J, Jiang ZW, Golm G, Huyck S, Terra SG, Mancuso JP, Engel SS, Lauring B. Ertugliflozin Compared with Glimepiride in Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin: The VERTIS SU Randomized Study. Diabetes Ther. 2018 Feb;9(1):193-207. doi: 10.1007/s13300-017-0354-4. Epub 2017 Dec 27.
PubMed 29282633

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 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Multicenter, Randomized, Double-Blind, Active-Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Ertugliflozin (MK-8835/PF-04971729) Compared With the Addition of Glimepiride in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin
ClinicalTrials.gov ID: NCT01999218
Acronym / sponsor ID: 8835-002
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,326 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: 16 Dec 2013 (actual)
Primary completion: 18 Apr 2017 (actual)
Study completion: 18 Apr 2017 (actual)
First posted: 3 Dec 2013 (estimated)
Results: Posted 11 May 2018

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 to Ertugliflozin, Drug: Placebo to Glimepiride, Drug: Metformin, Drug: SitagliptinErtugliflozin 5 mg once daily (QD) from Day 1 to Week 104
Ertugliflozin 15 mg	Experimental	Drug: Ertugliflozin 5 mg, Drug: Ertugliflozin 10 mg, Drug: Placebo to Glimepiride, Drug: Metformin, Drug: SitagliptinErtugliflozin 15 mg QD from Day 1 to Week 104
Glimepiride up to 8 mg	Active comparator	Drug: Glimerpiride, Drug: Placebo to Ertugliflozin, Drug: Metformin, Drug: SitagliptinGlimepiride to a maximum of 8 mg QD from Day 1 to Week 104

Who may qualify

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

Key inclusion criteria (5 listed)

Diagnosis of T2DM in accordance to American Diabetes Association guidelines
On metformin monotherapy or metformin in combination with a single allowable anti-hyperglycemic agent (AHA), DPP-4 inhibitors, meglitinides and AGIs are listed as allowable AHAs along with sulfonylureas prior to study participation.
Body Mass Index (BMI) ≥18.0 kg/m^2
Male or female not of reproductive potential
If a female of reproductive potential, agree 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.

Key exclusion criteria (23 listed)

History or presence of type 1 diabetes mellitus or a history of ketoacidosis
History of other specific types of diabetes (eg, genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant).
A known hypersensitivity or intolerance to any sodium-glucose co-transporter 2 (SGLT2) inhibitor
Use of the following prohibited therapeutic agents within 12 weeks of study participation: insulin, injectable anti-hyperglycemic agents, pioglitazone or rosiglitazone, another SGLT2 inhibitor, bromocriptine (Cycloset®), colesevelam (Welchol®), and any other non-approved anti-hyperglycemic therapy
Known hypersensitivity or intolerance to metformin or glimepiride

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-8835Ertugliflozin, 5 mg, oral, once daily, from Day 1 to Week 104	Drug	Ertugliflozin 15 mg, Ertugliflozin 5 mg
Ertugliflozin 10 mgAlso: MK-8355Ertugliflozin, 10 mg, oral, once daily from Day 1 to Week 104.	Drug	Ertugliflozin 15 mg
GlimerpirideGlimepiride, oral tablets, initiated at 1 mg daily and titrated up to the maximum approved dose (8 mg daily based on the local country label) or maximum tolerated dose	Drug	Glimepiride up to 8 mg
Placebo to ErtugliflozinMatching placebo to ertugliflozin, 5 mg and/or 10 mg, oral, once daily, from Day 1 to Week 104	Drug	Ertugliflozin 5 mg, Glimepiride up to 8 mg
Placebo to GlimepirideMatching placebo to glimepiride, 1 mg or 2 mg, oral, once daily, from Day 1 to Week 104.	Drug	Ertugliflozin 15 mg, Ertugliflozin 5 mg
MetforminParticipants are to remain on their stable doses of metformin (oral, >=1500 mg/day) while receiving blinded investigational product during the double-blind treatment period. Participants on metformin <1500 at screening are up-titrated to >= 1500 daily.	Drug	Ertugliflozin 15 mg, Ertugliflozin 5 mg, Glimepiride up to 8 mg
SitagliptinOpen label, oral, once daily, rescue medication as required.	Drug	Ertugliflozin 15 mg, Ertugliflozin 5 mg, Glimepiride up to 8 mg

Primary outcome

Change From Baseline in Hemoglobin A1C (A1C) at Week 52: Excluding Rescue Approach
Time frame: Baseline and Week 52
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 52 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication. The primary study objective was the MK-8835 15 mg vs. glimepiride comparison; the MK-8835 5mg vs glimerpiride comparison was a secondary study objective.
Percentage of Participants Experiencing An Adverse Event (AE) Up to Week 106
Time frame: Up to Week 106
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 Discontinuing Study Treatment Due to an AE Up to Week 104
Time frame: Up to Week 104
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.

3 secondary outcomes

Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 52: Excluding Rescue Approach
Time frame: Up to Week 52
Change From Baseline in Body Weight at Week 52 Excluding Rescue Approach
Time frame: Baseline and Week 52
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 52 Excluding Rescue Approach
Time frame: Baseline and Week 52

Results and safety

Results posted to the registry on 11 May 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
Ertugliflozin 5 mg	448	339
Ertugliflozin 15 mg	441	340
Glimepiride	437	327

Primary outcome: Change From Baseline in Hemoglobin A1C (A1C) at Week 52: Excluding Rescue Approach

Time frame: Baseline and Week 52. Least squares mean (95% Confidence Interval). Unit: Percent

Measure	Ertugliflozin 5 mg n = 448	Ertugliflozin 15 mg n = 440	Glimepiride n = 437
Value	-0.56 (-0.65 to -0.47)	-0.64 (-0.73 to -0.55)	-0.74 (-0.83 to -0.65)

Ertugliflozin 15 mg vs Glimepiride: Difference in the Least Squares Means: 0.10 (95% CI -0.02 to 0.22)
Ertugliflozin 5 mg vs Glimepiride: Difference in the Least Squares means: 0.18 (95% CI 0.06 to 0.30)

Population analysed: All randomized, treated participants with at least one A1C measurement (baseline or a post-baseline).

Primary outcome: Percentage of Participants Experiencing An Adverse Event (AE) Up to Week 106

Time frame: Up to Week 106. Number. Unit: Percentage of Participants

Measure	Ertugliflozin 5 mg n = 445	Ertugliflozin 15 mg n = 435	Glimepiride n = 435
Value	70.1	71.3	69.7

Ertugliflozin 15 mg vs Glimepiride: Difference in % vs. Glimepiride: 1.6 (95% CI -4.5 to 7.7)
Ertugliflozin 5 mg vs Glimepiride: Difference in % vs. Glimepiride: 0.5 (95% CI -5.6 to 6.5)

Population analysed: All randomized participants who took at least one dose of trial treatment, 10 randomized participants from one trial site were excluded from these analyzes, and one randomized participant did not receive treatment.

Primary outcome: Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 104

Time frame: Up to Week 104. Number. Unit: Percentage of Participants

Measure	Ertugliflozin 5 mg n = 445	Ertugliflozin 15 mg n = 435	Glimepiride n = 435
Value	6.5	8.0	5.1

Ertugliflozin 15 mg vs Glimepiride: Difference in % vs. Glimepiride: 3.0 (95% CI -0.3 to 6.4)
Ertugliflozin 5 mg vs Glimepiride: Difference in % vs. Glimepiride: 1.5 (95% CI -1.7 to 4.7)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Week 106. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ertugliflozin 5 mg	41 of 445 (9.2%)	110 of 445 (24.7%)	7 of 445
Ertugliflozin 15 mg	32 of 435 (7.4%)	104 of 435 (23.9%)	2 of 435
Glimepiride	30 of 435 (6.9%)	165 of 435 (37.9%)	1 of 435

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 30760125Hollander P, Hill J, Johnson J, Wei Jiang Z, Golm G, Huyck S, Terra SG, Mancuso JP, Engel SS, Lauring B, Liu J. Results of VERTIS SU extension study: safety and efficacy of ertugliflozin treatment over 104 weeks compared to glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin. Curr Med Res Opin. 2019 Aug;35(8):1335-1343. doi: 10.1080/03007995.2019.1583450. Epub 2019 Mar 25.
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 32236732Cherney DZI, Heerspink HJL, Frederich R, Maldonado M, Liu J, Pong A, Xu ZJ, Patel S, Hickman A, Mancuso JP, Gantz I, Terra SG. Effects of ertugliflozin on renal function over 104 weeks of treatment: a post hoc analysis of two randomised controlled trials. Diabetologia. 2020 Jun;63(6):1128-1140. doi: 10.1007/s00125-020-05133-4. Epub 2020 Mar 31.
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 29282633Hollander P, Liu J, Hill J, Johnson J, Jiang ZW, Golm G, Huyck S, Terra SG, Mancuso JP, Engel SS, Lauring B. Ertugliflozin Compared with Glimepiride in Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin: The VERTIS SU Randomized Study. Diabetes Ther. 2018 Feb;9(1):193-207. doi: 10.1007/s13300-017-0354-4. Epub 2017 Dec 27.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ertugliflozin 5 mg, Ertugliflozin 10 mg and Glimerpiride 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 5 inclusion and 23 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 2 Apr 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 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 11 May 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?

Change From Baseline in Hemoglobin A1C (A1C) at Week 52: Excluding Rescue Approach (time frame: Baseline and Week 52). 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 NCT01999218, 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 2 Apr 2019.