Clinical trial NCT02532855 (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: sitagliptin, dapagliflozin, metformin, matching placebo to sitagliptin, matching placebo to dapagliflozin, sulfonylurea
SMILES: N[C@@H](CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F, CN(C)C(=N)NC(N)=N, CSCC[C@H](N)C(O)=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, [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
Eligibility criteria:

        Inclusion Criteria

          -  Have T2DM at Screening visit

          -  Be on metformin monotherapy ≥1500 mg/day alone or in combination with an sulfonylurea
             agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational
             site) for ≥8 weeks

          -  Is a male or a female not of reproductive potential (defined as one who is
             postmenopausal or has had a hysterectomy and/or bilateral oophorectomy, or had
             bilateral tubal ligation or occlusion at least 6 weeks prior to Screening visit). If
             participant is a female of reproductive potential, must agree to remain abstinent from
             heterosexual activity or agrees to use (or have her partner use) acceptable
             contraception to prevent pregnancy while receiving blinded study drug and for 14 days
             after the last dose of blinded study drug

        Exclusion Criteria:

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

          -  Has a history of secondary causes of diabetes

          -  Has a known hypersensitivity or intolerance to any dipeptidyl peptidase IV (DPP-4)
             inhibitor or sodium-glucose cotransporter 2 (SGLT2) inhibitor

          -  Has been treated with any anti-hyperglycemic agents (AHA) other than metformin and for
             participants on dual combination therapy, a sulfonylurea within 12 weeks of screening

          -  Intends to initiate weight loss medication during the study period

          -  Has undergone bariatric surgery within 12 months of Screening visit

          -  Has started a weight loss medication or a medication associated with weight changes
             within the prior 12 weeks.

          -  Has a history of myocardial infarction, unstable angina, arterial revascularization,
             stroke, transient ischemic attack, heart failure within 3 months of Screening visit

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

          -  Has human immunodeficiency virus (HIV)

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

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

          -  Is currently being treated for hyperthyroidism or is on thyroid replacement therapy
             and has not been on a stable dose for at least 6 weeks prior to Screening visit

          -  Is on or likely to require treatment for ≥14 consecutive days or repeated courses of
             corticosteroids

          -  Is on or likely to require treatment for ≥7 consecutive days with non-steroidal
             anti-inflammatory drugs

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

          -  Is planning to undergo hormonal therapy in preparation to donate eggs during the
             study, including 14 days following the last dose of blinded study drug

          -  Routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week or
             engages in binge drinking

          -  Has donated blood or blood products within 6 weeks of Screening visit or who plans to
             donate blood or blood products at any time during the study