Clinical trial NCT02036515 (phase 3, status: completed)
Conditions: type 2 diabetes mellitus
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: ertugliflozin 5 mg, ertugliflozin 15 mg, placebo for ertugliflozin 5 mg, metformin, sitagliptin, glimepiride, placebo for ertugliflozin 10 mg
SMILES: CCOC1=CC=C(CC2=CC(=CC=C2Cl)[C@]23OC[C@](CO)(O2)[C@@H](O)[C@H](O)[C@H]3O)C=C1, CCOC1=CC=C(CC2=CC(=CC=C2Cl)[C@]23OC[C@](CO)(O2)[C@@H](O)[C@H](O)[C@H]3O)C=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CSCC[C@H](N)C(O)=O, N[C@@H](CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F, [H][C@]1(C)CC[C@@]([H])(CC1)N=C(O)NS(=O)(=O)C1=CC=C(CCN=C(O)N2CC(C)=C(CC)C2=O)C=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of type 2 diabetes mellitus (T2DM)

          -  On stable diabetes therapy of metformin with either sitagliptin or another dipeptidyl
             peptidase-4 (DPP-4) inhibitor or a sulfonylurea (SU) prior to study participation and
             is willing to wash-off/switch from another DPP-4 inhibitor/SU to sitagliptin

          -  Body Mass Index (BMI) greater than or equal to 18.0 kg/m^2

          -  Male, postmenopausal female or surgically sterile female

          -  If a female of reproductive potential, agrees to remain abstinent or to use (or have
             their partner use) 2 acceptable combinations of birth control while participating in
             the trial and for 14 days after the last use of study drug

        Exclusion Criteria:

          -  History of type 1 diabetes mellitus or a history of ketoacidosis

          -  History of other specific types of diabetes (e.g., genetic syndromes, secondary
             pancreatic diabetes, diabetes due to endocrine disorders, drug- or chemical-induced,
             and post-organ transplant)

          -  A known hypersensitivity or intolerance to any sodium-glucose co-transporter 2 (SGLT2)
             or DPP-4 inhibitor

          -  On a weight-loss program or weight-loss medication or other medication associated with
             weight changes and is not weight stable

          -  Has undergone bariatric surgery within the past 12 months or >12 months and is not
             weight stable

          -  Has been treated with insulin (except for short-term use [<= 7 days]), injectable
             antihyperglycemic agents (AHAs) (e.g., pramlintide, exenatide, liraglutide),
             pioglitazone or rosiglitazone, other sodium-glucose co-transporter 2 (SGLT2)
             inhibitors, alpha glucosidase inhibitors or meglitinides, bromocriptine (Cycloset™),
             colesevelam (Welchol™), or any other non-protocol approved AHAs within 12 weeks of
             study participation

          -  Has active, obstructive uropathy or indwelling urinary catheter

          -  History of myocardial infarction, unstable angina, arterial revascularization, stroke,
             transient ischemic attack, or New York Heart Association (NYHA) functional class
             III-IV heart failure within 3 months of study participation

          -  A history of malignancy ≤5 years prior to study participation, except for adequately
             treated basal or squamous cell skin cancer or in situ cervical cancer

          -  Known history of Human Immunodeficiency Virus (HIV)

          -  Has blood dyscrasias or any disorders causing hemolysis or unstable red blood cells or
             any other clinically significant hematological disorder (such as aplastic anemia,
             myeloproliferative or myelodysplastic syndromes, thrombocytopenia)

          -  A medical history of active liver disease (other than nonalcoholic hepatic steatosis),
             including chronic active hepatitis B or C, primary biliary cirrhosis, or active
             symptomatic gallbladder disease

          -  Has any clinically significant malabsorption condition

          -  If taking thyroid replacement therapy, has not been on a stable dose for at least 6
             weeks prior to study participation

          -  Has been previously randomized in a study with ertugliflozin

          -  Has participated in other studies involving an investigational drug within 30 days
             prior or during study participation

          -  Has undergone a surgical procedure within 6 weeks prior to or planned major surgery
             during study participation

          -  Has a positive urine pregnancy test

          -  Is pregnant or breast-feeding, or is planning to conceive during the trial, including
             14 days following the last dose of study medication

          -  Planning to undergo hormonal therapy in preparation to donate eggs during the trial,
             including 14 days following the last dose of study medication

          -  Excessive consumption of alcoholic beverages or binge drinking

          -  Has donated blood or blood products within 6 weeks of study participation or plans to
             donate blood or blood products at any time during the trial