Ertugliflozin and Sitagliptin Co-administration Factorial Study (VERTIS FACTORAL, MK-8835-005)
NCT ID: NCT02099110
Last Updated: 2018-09-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1233 participants
INTERVENTIONAL
2014-04-22
2016-05-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ertugliflozin 5 mg + sitagliptin 100 mg
Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
Matching Placebo to Ertugliflozin 10 mg
Placebo to ertugliflozin 10 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period
Ertugliflozin 5 mg
Ertugliflozin 5 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period
Sitagliptin 100 mg
Sitagliptin 100 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period
Metformin >= 1500 mg/day
Metformin \>= 1500 mg/day, tablets, oral, for 52 weeks while receiving blinded investigational product during the double-blind treatment period
Insulin Glargine Rescue Medication
Open-label insulin glargine, subcutaneous injection, as required as a rescue medication; dose determined per the investigator's discretion
Glimepiride Rescue Medication
Open-label glimepiride tablets, oral, as required as a rescue medication, dose determined per the investigator's discretion
Ertugliflozin 15 mg + sitagliptin 100 mg
Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks
Ertugliflozin 5 mg
Ertugliflozin 5 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period
Ertugliflozin 10 mg
Ertugliflozin 10 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period
Sitagliptin 100 mg
Sitagliptin 100 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period
Metformin >= 1500 mg/day
Metformin \>= 1500 mg/day, tablets, oral, for 52 weeks while receiving blinded investigational product during the double-blind treatment period
Insulin Glargine Rescue Medication
Open-label insulin glargine, subcutaneous injection, as required as a rescue medication; dose determined per the investigator's discretion
Glimepiride Rescue Medication
Open-label glimepiride tablets, oral, as required as a rescue medication, dose determined per the investigator's discretion
Ertugliflozin 5 mg
Ertugliflozin 5 mg, oral, once daily for 52 weeks
Matching Placebo to Ertugliflozin 10 mg
Placebo to ertugliflozin 10 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period
Matching Placebo to sitagliptin 100 mg
Placebo to sitagliptin 100 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period
Ertugliflozin 5 mg
Ertugliflozin 5 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period
Metformin >= 1500 mg/day
Metformin \>= 1500 mg/day, tablets, oral, for 52 weeks while receiving blinded investigational product during the double-blind treatment period
Insulin Glargine Rescue Medication
Open-label insulin glargine, subcutaneous injection, as required as a rescue medication; dose determined per the investigator's discretion
Glimepiride Rescue Medication
Open-label glimepiride tablets, oral, as required as a rescue medication, dose determined per the investigator's discretion
Ertugliflozin 15 mg
Ertugliflozin, oral, once daily for 52 weeks
Matching Placebo to sitagliptin 100 mg
Placebo to sitagliptin 100 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period
Ertugliflozin 5 mg
Ertugliflozin 5 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period
Ertugliflozin 10 mg
Ertugliflozin 10 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period
Metformin >= 1500 mg/day
Metformin \>= 1500 mg/day, tablets, oral, for 52 weeks while receiving blinded investigational product during the double-blind treatment period
Insulin Glargine Rescue Medication
Open-label insulin glargine, subcutaneous injection, as required as a rescue medication; dose determined per the investigator's discretion
Glimepiride Rescue Medication
Open-label glimepiride tablets, oral, as required as a rescue medication, dose determined per the investigator's discretion
Sitagliptin 100 mg
Sitagliptin 100 mg, oral, once daily for 52 weeks
Matching Placebo to Ertugliflozin 5 mg
Placebo to ertugliflozin 5 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period
Matching Placebo to Ertugliflozin 10 mg
Placebo to ertugliflozin 10 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period
Sitagliptin 100 mg
Sitagliptin 100 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period
Metformin >= 1500 mg/day
Metformin \>= 1500 mg/day, tablets, oral, for 52 weeks while receiving blinded investigational product during the double-blind treatment period
Insulin Glargine Rescue Medication
Open-label insulin glargine, subcutaneous injection, as required as a rescue medication; dose determined per the investigator's discretion
Glimepiride Rescue Medication
Open-label glimepiride tablets, oral, as required as a rescue medication, dose determined per the investigator's discretion
Interventions
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Matching Placebo to Ertugliflozin 5 mg
Placebo to ertugliflozin 5 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period
Matching Placebo to Ertugliflozin 10 mg
Placebo to ertugliflozin 10 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period
Matching Placebo to sitagliptin 100 mg
Placebo to sitagliptin 100 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period
Ertugliflozin 5 mg
Ertugliflozin 5 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period
Ertugliflozin 10 mg
Ertugliflozin 10 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period
Sitagliptin 100 mg
Sitagliptin 100 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period
Metformin >= 1500 mg/day
Metformin \>= 1500 mg/day, tablets, oral, for 52 weeks while receiving blinded investigational product during the double-blind treatment period
Insulin Glargine Rescue Medication
Open-label insulin glargine, subcutaneous injection, as required as a rescue medication; dose determined per the investigator's discretion
Glimepiride Rescue Medication
Open-label glimepiride tablets, oral, as required as a rescue medication, dose determined per the investigator's discretion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* On metformin monotherapy (\>=1500 mg/day) for \>=8 weeks with a Visit 1/Screening A1C \>=7.5% and \<=11.0% (\>=58 mmol/mol and \<=97 mmol/mol) OR On metformin monotherapy (\>=1500 mg/day) for \<8 weeks with a Visit 1/Screening A1C \>=7.5% and \<=11.0% (\>=58 mmol/mol and \<=97 mmol/mol) OR On metformin monotherapy \<1500 mg/day with a Visit 1/Screening A1C \>=8.0% and \<=11.5% (\>=64 mmol/mol and \<=102 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
Exclusion Criteria
* 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
* A known hypersensitivity or intolerance to any sodium glucose co-transporter 2 (SGLT2) inhibitor or sitagliptin
* 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 \[i.e., \<=7 days\] during concomitant illness or other stress), other injectable anti-hyperglycemic agents (e.g., pramlintide, exenatide, liraglutide), pioglitazone or rosiglitazone, other SGLT2 inhibitors, alpha glucosidase inhibitors or meglitinides, dipeptidyl-peptidase 4 inhibitor (DPP-4 inhibitor), sulfonylureas (SUs), bromocriptine (Cycloset™), colesevelam (Welchol™), any other antihyperglycemic agents (AHA) with the exception of the protocol-approved agents
* 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 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
* 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
* A known history of human immunodeficiency virus (HIV)
* A blood dyscrasia or any disorder causing hemolysis or unstable red blood cells, or a clinically important hematological disorder (e.g. 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 symptomatic gallbladder disease
* Any clinically significant malabsorption condition
* Current treatment for hyperthyroidism
* On thyroid replacement therapy and not on a stable dose for at least 6 weeks prior study start
* On a previous clinical study with ertugliflozin
* Estimated glomerular filtration rate (eGFR) (using the 4-variable Modification of Diet in Renal Disease Study Equation (MDRD) equation) \<60 mL/min/1.73 m\^2
* Serum creatinine \>= 1.3 mg/dL (115 µmol/L) for males and \>= 1.2 mg/dL (106 µmol/L) for females
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2 times upper limit of normal
* Hemoglobin \<12 g/dL (120 g/L) for males and \<11 g/dL (110 g/L) for females.
* Participated in other studies involving investigational drug(s) 30 days prior to study start
* Surgical procedure within 6 weeks prior to study start or major surgery planned during the trial
* Positive urine pregnancy test
* 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
* Routinely consumes \>2 alcoholic drinks per day or \>14 alcoholic drinks per week or engages in binge drinking
* Donated blood or blood products within 6 weeks of study start
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Pratley RE, Eldor R, Raji A, Golm G, Huyck SB, Qiu Y, Sunga S, Johnson J, Terra SG, Mancuso JP, Engel SS, Lauring B. Ertugliflozin plus sitagliptin versus either individual agent over 52 weeks in patients with type 2 diabetes mellitus inadequately controlled with metformin: The VERTIS FACTORIAL randomized trial. Diabetes Obes Metab. 2018 May;20(5):1111-1120. doi: 10.1111/dom.13194. Epub 2018 Jan 25.
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.
Gallo S, Raji A, Calle RA, Pong A, Meyer C. The effects of ertugliflozin on beta-cell function: Pooled analysis from four phase 3 randomized controlled studies. Diabetes Obes Metab. 2020 Dec;22(12):2267-2275. doi: 10.1111/dom.14149. Epub 2020 Aug 27.
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.
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.
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.
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.
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.
Other Identifiers
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MK-8835-005
Identifier Type: OTHER
Identifier Source: secondary_id
B1521019
Identifier Type: OTHER
Identifier Source: secondary_id
2013-003698-82
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
8835-005
Identifier Type: -
Identifier Source: org_study_id
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