Type 2 Diabetes MellitusPhase 3NCT02630706

A Study to Evaluate the Efficacy and Safety of Ertugliflozin in Asian Participants With Type 2 Diabetes and Inadequate Glycemic Control on Metformin Monotherapy (MK-8835-012)

A Phase 3 study testing Ertugliflozin 5 mg, Ertugliflozin 15 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 15 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: 506 participants
Where: No sites listed yet
Study dates: 16 Dec 2015to 27 Dec 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

Asian participants ≥18 years of age at the time of initial Screening.
Type 2 diabetes mellitus as per American Diabetes Association guidelines.
Metformin monotherapy (≥1500 mg/day) with an initial Screening A1C of 7.0-10.5% (53-91 mmol/mol) OR metformin monotherapy (<1500 mg/day) with an initial Screening A1C of 7.5-11.0% (58-97 mmol/mol) OR dual combination therapy with metformin + sulfonylurea, dipeptidyl peptidase-4 (DDP-4) inhibitor, meglitinide, or alpha-glucosidase inhibitor with an initial Screening A1C of 6.5-9.5% (48-80 mmol/mol).
Body mass index (BMI) ≥18.0 kg/m^2.
Male or female not of reproductive potential.
Female of reproductive potential who agrees to remain abstinent from heterosexual activity or to use 2 acceptable combinations of contraception.

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 endocrinopathies, drug- or chemical-induced, and post-organ transplant.)
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 start.
Mean value for triplicate screening sitting systolic blood pressure >160 mm Hg and/or diastolic blood pressure >90 mm Hg after at least a 5-minute seated rest at screening
Active, obstructive uropathy or indwelling urinary catheter.
History of malignancy ≤5 years prior to study start, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.

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Routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week or engages in binge drinking.
Any clinically significant malabsorption condition.
Is on a weight-loss program or weight-loss medication or other medication associated with weight changes and is not weight stable prior to study start.
Has undergone bariatric surgery within the past 12 months or >12 months and is not weight stable prior to study start.
A known hypersensitivity or intolerance to any sodium glucose co-transporter (SGLT2) inhibitor.
On a previous clinical study with ertugliflozin.
Is taking blood pressure or lipid altering medications that have not been on a stable dose for at least 4 weeks prior to study start.
Current treatment for hyperthyroidism.
Male participants with a serum creatinine >=1.3 mg/dL (>=115 mol/L) or female participants with a serum creatinine >=1.2 mg/dL (>=106 mol/L) or participants with an estimated glomerular filtration rate (eGFR) <55 mL/min/1.73m^2 according to the 4-variable Modification of Diet in Renal Disease (MDRD) equation at screening.
An aspartate transaminase (AST) or alanine transaminase (ALT) >2X the upper limit of normal (ULN) range at screening, or a total bilirubin >1.5 X the ULN unless the participant has a history of Gilbert's.
On thyroid replacement therapy and has not been on a stable dose for at least 6 weeks prior to study start.
A medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease.
Has been treated with any of the following agents within 12 weeks of study start or during the pre-randomization period: Insulin of any type (except for short-term use during concomitant illness or other stress), other injectable anti-hyperglycemic agents (e.g., pramlintide, exenatide, liraglutide), another SGLT2 inhibitor, bromocriptine, colesevelam, rosiglitazone or pioglitazone, or any other AHA with the exception of the protocol-approved agents.
Is on or likely to require treatment ≥14 consecutive days or repeated courses of pharmacologic doses of corticosteroids.
Has undergone a surgical procedure within 6 weeks prior to study start or has planned major surgery during the study.
Pregnant or breast-feeding, or planning to conceive during the trial, including 14 days following the last dose of study medication.
Planning to undergo hormonal therapy in preparation for egg donation during the trial, including 14 days following the last dose of study medication.
Donated blood or blood products within 6 weeks of study start.
Has Human Immunodeficiency Virus (HIV).
Has blood dyscrasias or any disorders causing hemolysis or unstable red blood cells.
Has clinically important hematological disorders (such as aplastic anemia, myeloproliferative or myelodyplastic syndromes, thrombocytopenia.)

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 26-Week Multicenter Study to Evaluate the Efficacy and Safety of Ertugliflozin in Asian Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control on Metformin Monotherapy (VERTIS-ASIA)

This is a study to evaluate the efficacy and safety of the addition of ertugliflozin to metformin monotherapy in Asian participants with Type 2 diabetes mellitis (T2DM) who have inadequate glycemic control on metformin monotherapy. The primary hypothesis is that the mean reduction from baseline in HbA1C for 15 mg and 5 mg ertugliflozin (tested sequentially) is greater than for placebo.

Read the detailed description

This study includes a 1-week screening period, an 8-week (or greater) antihyperglycemic agent (AHA) wash-off and/or metformin dose stable period (as necessary), a 2-week single-blind placebo run-in period, a 26-week double-blind 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 15 mg, Placebo matching ertugliflozin, Metformin, 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, PF-04971729
Ertugliflozin 5 mg oral tablet taken once daily
Ertugliflozin 15 mgDrug
Also called MK-8835, PF-04971729
Ertugliflozin 15 mg (5-mg and 10-mg tablets) oral taken once daily
Placebo matching ertugliflozinDrug
Placebo matching ertugliflozin (5-mg and/or 10-mg tablet) oral taken once daily
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.
GlimepirideDrug
Glycemic rescue therapy with open-label glimepiride will be initiated in participants with glucose values exceeding protocol-specified values. Dosing and titration of open-label glimepiride rescue therapy will be at the Investigator's discretion.

Study groups in NCT02630706
Study group	Role	What they receive
Ertugliflozin 5 mg	Experimental	Ertugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. Receives: Drug: Ertugliflozin 5 mg; Drug: Placebo matching ertugliflozin; Drug: Metformin; Drug: Glimepiride
Ertugliflozin 15 mg	Experimental	Ertugliflozin 15 mg (ertugliflozin 5 mg + ertugliflozin 10 mg) administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. Receives: Drug: Ertugliflozin 15 mg; Drug: Metformin; Drug: Glimepiride
Placebo	Placebo comparator	Placebo matching ertugliflozin administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values. Receives: Drug: Placebo matching 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 (Excluding Rescue Approach)
A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 26 A1C minus the Week 0 A1C (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
Measured: Baseline and Week 26
Change From Baseline in A1C (%) at Week 26 (Excluding Rescue Approach) (China Subpopulation)
A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 26 A1C minus the Week 0 A1C (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
Measured: Baseline and Week 26
Percentage of Participants Experiencing An Adverse Event (AE) (Including Rescue Approach)
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 28 weeks
Percentage of Participants Experiencing An Adverse Event (AE) (Including Rescue Approach) (China Subpopulation)
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 28 weeks
Percentage of Participants Discontinuing Study Treatment Due to an AE (Including Rescue Approach)
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 26 weeks
Percentage of Participants Discontinuing Study Treatment Due to an AE (Including Rescue Approach) (China Subpopulation)
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 26 weeks

Secondary outcomes (28)

Change From Baseline in Fasting Plasma Glucose at Week 26 (Excluding Rescue Approach)
Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at Week 0) which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
Measured: Baseline and Week 26
Change From Baseline in Fasting Plasma Glucose at Week 26 (Excluding Rescue Approach) (China Subpopulation)
Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at Week 0) which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
Measured: Baseline and Week 26
Change From Baseline in Body Weight at Week 26 (Excluding Rescue Approach)
The change in body weight from baseline reflects the Week 26 body weight minus the Week 0 body weight (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
Measured: Baseline and Week 26
Change From Baseline in Body Weight at Week 26 (Excluding Rescue Approach) (China Subpopulation)
The change in body weight from baseline reflects the Week 26 body weight minus the Week 0 body weight (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
Measured: Baseline and Week 26
Percentage of Participants With HbA1c of <7.0% (53 mmol/Mol) (Logistic Regression Using Multiple Imputation Based on cLDA Model: 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 (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
Measured: Week 26
Percentage of Participants With HbA1c of <7.0% (53 mmol/Mol) (Logistic Regression Using Multiple Imputation Based on cLDA Model: Excluding Rescue Approach) (China Subpopulation)
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
Measured: Week 26
Change From Baseline in Sitting Systolic Blood Pressure at Week 26 (Excluding Rescue Approach)
This change from baseline reflects the Week 26 sitting systolic blood pressure (SBP) minus the Week 0 sitting SBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
Measured: Baseline and Week 26
Change From Baseline in Sitting Systolic Blood Pressure at Week 26 (Excluding Rescue Approach) (China Subpopulation)
This change from baseline reflects the Week 26 sitting systolic blood pressure (SBP) minus the Week 0 sitting SBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
Measured: Baseline and Week 26
Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 (Excluding Rescue Approach)
This change from baseline reflects the Week 26 sitting diastolic blood pressure (DBP) minus the Week 0 sitting DBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
Measured: Baseline and Week 26
Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 (Excluding Rescue Approach) (China Subpopulation)
This change from baseline reflects the Week 26 sitting diastolic blood pressure (DBP) minus the Week 0 sitting DBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
Measured: Baseline and Week 26
Percentage of Participants With HbA1c of <6.5% (48 mmol/Mol) at Week 26 (Logistic Regression Using Multiple Imputation: 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 (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
Measured: Week 26
Percentage of Participants With HbA1c of <6.5% (48 mmol/Mol) at Week 26 (Logistic Regression Using Multiple Imputation: Excluding Rescue Approach) (China Subpopulation)
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
Measured: Week 26
Percentage of Participants Requiring Glycemic Rescue Therapy Through Week 26.
Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment.
Measured: Week 26
Percentage of Participants Requiring Glycemic Rescue Therapy Through Week 26 (China Subpopulation)
Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment.
Measured: Week 26
Time to Glycemic Rescue Therapy
Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment.
Measured: Up to 183 days
Time to Glycemic Rescue Therapy (China Subpopulation)
Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment.
Measured: Up to 149 days
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL.
Measured: Week 6: Pre-Dose
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL.
Measured: Week 12: Pre-Dose
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL.
Measured: Week 12: 60 min. Post-Dose
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL.
Measured: Week 18: Pre-Dose
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL.
Measured: Week 18: 60 min. Post-Dose
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL.
Measured: Week 26: Pre-Dose
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation)
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL.
Measured: Week 6: Pre-Dose
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation)
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL.
Measured: Week 12: Pre-Dose
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation)
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL.
Measured: Week 12: 60 min. Post-Dose
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation)
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL.
Measured: Week 18: Pre-Dose
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation)
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL.
Measured: Week 18: 60 min. Post-Dose
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation)
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL.
Measured: Week 26: Pre-Dose

Timeline

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

16 Dec 201527 Dec 2017

First posted15 Dec 2015 (estimated)
Study start16 Dec 2015
Primary completion27 Dec 2017
Study completion27 Dec 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 (4)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: 506 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02630706
Sponsor's protocol ID: 8835-012
Other IDs: B1521045, MK-8835-012
Status last verified: Nov 2018
First submitted: 11 Dec 2015
Last updated: 7 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Ji L, Liu J, Xu ZJ, Wei Z, Zhang R, Malkani S, Cater NB, Frederich R. Efficacy and Safety of Ertugliflozin Added to Metformin: A Pooled Population from Asia with Type 2 Diabetes and Overweight or Obesity. Diabetes Ther. 2023 Feb;14(2):319-334. doi: 10.1007/s13300-022-01345-6. Epub 2023 Feb 3.
PubMed 36763328
Xu H, O'Gorman MT, Nepal S, James LP, Ginman K, Pithavala YK. Phase 1 Study Evaluating the Effects of the Proton Pump Inhibitor Rabeprazole and Food on the Pharmacokinetics of Lorlatinib in Healthy Participants. Clin Pharmacol Drug Dev. 2021 Nov;10(11):1395-1404. doi: 10.1002/cpdd.1000. Epub 2021 Jul 20.
PubMed 34288547
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
Ji L, Liu Y, Miao H, Xie Y, Yang M, Wang W, Mu Y, Yan P, Pan S, Lauring B, Liu S, Huyck S, Qiu Y, Terra SG. Safety and efficacy of ertugliflozin in Asian patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy: VERTIS Asia. Diabetes Obes Metab. 2019 Jun;21(6):1474-1482. doi: 10.1111/dom.13681. Epub 2019 Apr 5.
PubMed 30830724

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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Study at a glance

From the registry record, last updated by the sponsor on 7 Dec 2018. 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 to Evaluate the Efficacy and Safety of Ertugliflozin in Asian Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control on Metformin Monotherapy (VERTIS-ASIA)
ClinicalTrials.gov ID: NCT02630706
Acronym / sponsor ID: 8835-012
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 506 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: 16 Dec 2015 (actual)
Primary completion: 27 Dec 2017 (actual)
Study completion: 27 Dec 2017 (actual)
First posted: 15 Dec 2015 (estimated)
Results: Posted 7 Dec 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 matching ertugliflozin, Drug: Metformin, Drug: GlimepirideErtugliflozin 5 mg oral and matching placebo for ertugliflozin 10 mg, oral, once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values.
Ertugliflozin 15 mg	Experimental	Drug: Ertugliflozin 15 mg, Drug: Metformin, Drug: GlimepirideErtugliflozin 15 mg (ertugliflozin 5 mg + ertugliflozin 10 mg) administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values.
Placebo	Placebo comparator	Drug: Placebo matching ertugliflozin, Drug: Metformin, Drug: GlimepiridePlacebo matching ertugliflozin administered orally once daily for 26 weeks, while maintaining metformin at a stable dose (>=1500 mg/day). Glycemic rescue therapy with open-label glimepiride was initiated in participants with glucose values exceeding protocol-specified values.

Who may qualify

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

Key inclusion criteria (6 listed)

Asian participants ≥18 years of age at the time of initial Screening.
Type 2 diabetes mellitus as per American Diabetes Association guidelines.
Metformin monotherapy (≥1500 mg/day) with an initial Screening A1C of 7.0-10.5% (53-91 mmol/mol) OR metformin monotherapy (<1500 mg/day) with an initial Screening A1C of 7.5-11.0% (58-97 mmol/mol) OR dual combination therapy with metformin + sulfonylurea, dipeptidyl peptidase-4 (DDP-4) inhibitor, meglitinide, or alpha-glucosidase inhibitor with an initial Screening A1C of 6.5-9.5% (48-80 mmol/mol).
Body mass index (BMI) ≥18.0 kg/m^2.
Male or female not of reproductive potential.

Key exclusion criteria (27 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 endocrinopathies, drug- or chemical-induced, and post-organ transplant.)
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 start.
Mean value for triplicate screening sitting systolic blood pressure >160 mm Hg and/or diastolic blood pressure >90 mm Hg after at least a 5-minute seated rest at screening
Active, obstructive uropathy or indwelling urinary catheter.

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 5 mg oral tablet taken once daily	Drug	Ertugliflozin 5 mg
Ertugliflozin 15 mgAlso: MK-8835, PF-04971729Ertugliflozin 15 mg (5-mg and 10-mg tablets) oral taken once daily	Drug	Ertugliflozin 15 mg
Placebo matching ertugliflozinPlacebo matching ertugliflozin (5-mg and/or 10-mg tablet) oral taken once daily	Drug	Ertugliflozin 5 mg, Placebo
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, Placebo
GlimepirideGlycemic rescue therapy with open-label glimepiride will be initiated in participants with glucose values exceeding protocol-specified values. Dosing and titration of open-label glimepiride rescue therapy will be at the Investigator's discretion.	Drug	Ertugliflozin 15 mg, 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. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 26 A1C minus the Week 0 A1C (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
Change From Baseline in A1C (%) at Week 26 (Excluding Rescue Approach) (China Subpopulation)
Time frame: Baseline and Week 26
A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 26 A1C minus the Week 0 A1C (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.
Percentage of Participants Experiencing An Adverse Event (AE) (Including Rescue Approach)
Time frame: Up to 28 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 Experiencing An Adverse Event (AE) (Including Rescue Approach) (China Subpopulation)
Time frame: Up to 28 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 Discontinuing Study Treatment Due to an AE (Including Rescue Approach)
Time frame: Up to 26 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 Discontinuing Study Treatment Due to an AE (Including Rescue Approach) (China Subpopulation)
Time frame: Up to 26 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.

28 secondary outcomes

Change From Baseline in Fasting Plasma Glucose at Week 26 (Excluding Rescue Approach)
Time frame: Baseline and Week 26
Change From Baseline in Fasting Plasma Glucose at Week 26 (Excluding Rescue Approach) (China Subpopulation)
Time frame: Baseline and Week 26
Change From Baseline in Body Weight at Week 26 (Excluding Rescue Approach)
Time frame: Baseline and Week 26
Change From Baseline in Body Weight at Week 26 (Excluding Rescue Approach) (China Subpopulation)
Time frame: Baseline and Week 26
Percentage of Participants With HbA1c of <7.0% (53 mmol/Mol) (Logistic Regression Using Multiple Imputation Based on cLDA Model: Excluding Rescue Approach)
Time frame: Week 26
Percentage of Participants With HbA1c of <7.0% (53 mmol/Mol) (Logistic Regression Using Multiple Imputation Based on cLDA Model: Excluding Rescue Approach) (China Subpopulation)
Time frame: Week 26
Change From Baseline in Sitting Systolic Blood Pressure at Week 26 (Excluding Rescue Approach)
Time frame: Baseline and Week 26
Change From Baseline in Sitting Systolic Blood Pressure at Week 26 (Excluding Rescue Approach) (China Subpopulation)
Time frame: Baseline and Week 26
Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 (Excluding Rescue Approach)
Time frame: Baseline and Week 26
Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 (Excluding Rescue Approach) (China Subpopulation)
Time frame: Baseline and Week 26
Percentage of Participants With HbA1c of <6.5% (48 mmol/Mol) at Week 26 (Logistic Regression Using Multiple Imputation: Excluding Rescue Approach)
Time frame: Week 26
Percentage of Participants With HbA1c of <6.5% (48 mmol/Mol) at Week 26 (Logistic Regression Using Multiple Imputation: Excluding Rescue Approach) (China Subpopulation)
Time frame: Week 26
Percentage of Participants Requiring Glycemic Rescue Therapy Through Week 26.
Time frame: Week 26
Percentage of Participants Requiring Glycemic Rescue Therapy Through Week 26 (China Subpopulation)
Time frame: Week 26
Time to Glycemic Rescue Therapy
Time frame: Up to 183 days
Time to Glycemic Rescue Therapy (China Subpopulation)
Time frame: Up to 149 days
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach
Time frame: Week 6: Pre-Dose
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach
Time frame: Week 12: Pre-Dose
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach
Time frame: Week 12: 60 min. Post-Dose
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach
Time frame: Week 18: Pre-Dose
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach
Time frame: Week 18: 60 min. Post-Dose
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach
Time frame: Week 26: Pre-Dose
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation)
Time frame: Week 6: Pre-Dose
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation)
Time frame: Week 12: Pre-Dose
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation)
Time frame: Week 12: 60 min. Post-Dose
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation)
Time frame: Week 18: Pre-Dose
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation)
Time frame: Week 18: 60 min. Post-Dose
Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation)
Time frame: Week 26: Pre-Dose

Results and safety

Results posted to the registry on 7 Dec 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	170	163
Ertugliflozin 15 mg	169	160
Placebo	167	157

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 A1C

Measure	Ertugliflozin 5 mg n = 170	Ertugliflozin 15 mg n = 169	Placebo n = 167
Value	-1.00 (-1.12 to -0.88)	-0.89 (-1.01 to -0.77)	-0.20 (-0.33 to -0.08)

Ertugliflozin 15 mg vs Placebo: Difference in the LSM vs. placebo: -0.69 (95% CI -0.85 to -0.52), p <0.001, cLDA
Ertugliflozin 5 mg vs Placebo: Difference in the LS Means vs. Placebo: -0.80 (95% CI -0.97 to -0.63), p <0.001, cLDA

Population analysed: The analysis population included all randomized participants who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post baseline up to Week 26.

Primary outcome: Change From Baseline in A1C (%) at Week 26 (Excluding Rescue Approach) (China Subpopulation)

Time frame: Baseline and Week 26. Least squares mean (95% Confidence Interval). Unit: Percentage A1C

Measure	Ertugliflozin 5 mg n = 136	Ertugliflozin 15 mg n = 135	Placebo n = 135
Value	-1.01 (-1.14 to -0.87)	-0.92 (-1.05 to -0.79)	-0.24 (-0.38 to -0.10)

Ertugliflozin 15 mg vs Placebo: Difference in the LSM vs. placebo: -0.68 (95% CI -0.86 to -0.50), p <0.001, cLDA
Ertugliflozin 5 mg vs Placebo: Difference in the LS Means vs. Placebo: -0.76 (95% CI -0.95 to -0.58), p <0.001, cLDA

Population analysed: The analysis population included all randomized participants in China who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post baseline up to Week 26.

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

Time frame: Up to 28 weeks. Number. Unit: Percentage of participants

Measure	Ertugliflozin 5 mg n = 170	Ertugliflozin 15 mg n = 169	Placebo n = 167
Value	56.5	53.3	59.3

Ertugliflozin 15 mg vs Placebo: Difference in % vs. Placebo: -6.0 (95% CI -16.5 to 4.6)
Ertugliflozin 5 mg vs Placebo: Difference in % vs. Placebo: -2.8 (95% CI -13.3 to 7.7)

Population analysed: The analysis population included all randomized participants who received at least one dose of investigational product.

Primary outcome: Percentage of Participants Experiencing An Adverse Event (AE) (Including Rescue Approach) (China Subpopulation)

Time frame: Up to 28 weeks. Number. Unit: Percentage of participants

Measure	Ertugliflozin 5 mg n = 136	Ertugliflozin 15 mg n = 135	Placebo n = 135
Value	54.4	50.4	59.3

Ertugliflozin 15 mg vs Placebo: Difference in % vs. Placebo: -8.9 (95% CI -20.5 to 3.0)
Ertugliflozin 5 mg vs Placebo: Difference in % vs. Placebo: -4.8 (95% CI -16.5 to 6.9)

Population analysed: The analysis population included all randomized participants in China who received at least one dose of investigational product .

28 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 28 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ertugliflozin 5 mg	9 of 170 (5.3%)	22 of 170 (12.9%)	0 of 170
Ertugliflozin 15 mg	10 of 169 (5.9%)	31 of 169 (18.3%)	0 of 169
Placebo	2 of 167 (1.2%)	44 of 167 (26.3%)	0 of 167

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36763328Ji L, Liu J, Xu ZJ, Wei Z, Zhang R, Malkani S, Cater NB, Frederich R. Efficacy and Safety of Ertugliflozin Added to Metformin: A Pooled Population from Asia with Type 2 Diabetes and Overweight or Obesity. Diabetes Ther. 2023 Feb;14(2):319-334. doi: 10.1007/s13300-022-01345-6. Epub 2023 Feb 3.
Derived from this study: PubMed 34288547Xu H, O'Gorman MT, Nepal S, James LP, Ginman K, Pithavala YK. Phase 1 Study Evaluating the Effects of the Proton Pump Inhibitor Rabeprazole and Food on the Pharmacokinetics of Lorlatinib in Healthy Participants. Clin Pharmacol Drug Dev. 2021 Nov;10(11):1395-1404. doi: 10.1002/cpdd.1000. Epub 2021 Jul 20.
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 30830724Ji L, Liu Y, Miao H, Xie Y, Yang M, Wang W, Mu Y, Yan P, Pan S, Lauring B, Liu S, Huyck S, Qiu Y, Terra SG. Safety and efficacy of ertugliflozin in Asian patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy: VERTIS Asia. Diabetes Obes Metab. 2019 Jun;21(6):1474-1482. doi: 10.1111/dom.13681. Epub 2019 Apr 5.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

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

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ertugliflozin 5 mg, Ertugliflozin 15 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 6 inclusion and 27 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 7 Dec 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 7 Dec 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 A1C (%) at Week 26 (Excluding Rescue Approach) (time frame: Baseline and Week 26). The study lists 6 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 NCT02630706, which also lists 4 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 7 Dec 2018.