Clinical trial NCT02254291 (phase 3, status: completed)
Conditions: diabetes, diabetes mellitus, type 2
ICD codes: E23.2, N25.1, P70.2, O24.92, Z83.3, Z86.32, E10.65, E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: semaglutide, semaglutide, sitagliptin
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](CC1=CC=CC=C1)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CC[C@@H](NC(=O)CCCCCCCCCCCCCCCCC(O)=O)C(O)=O)NC(=O)[C@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(N)=O)NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC1=CC=CC=C1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)C(C)(C)NC(=O)[C@@H](N)CC1=CNC=N1)[C@@H](C)O)[C@@H](C)O)C(C)C)C(=O)N[C@@H](C)C(=O)N[C@@H](CC1=CNC2=C1C=CC=C2)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(O)=O, CC[C@H](C)[C@H](NC(=O)[C@H](CC1=CC=CC=C1)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CC[C@@H](NC(=O)CCCCCCCCCCCCCCCCC(O)=O)C(O)=O)NC(=O)[C@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(N)=O)NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC1=CC=CC=C1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)C(C)(C)NC(=O)[C@@H](N)CC1=CNC=N1)[C@@H](C)O)[C@@H](C)O)C(C)C)C(=O)N[C@@H](C)C(=O)N[C@@H](CC1=CNC2=C1C=CC=C2)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(O)=O, N[C@@H](CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F
Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age 20 years or older at the time of signing informed consent

          -  Glycated hemoglobin (HbA1c) between 6.5% and 9.5% (48-80 mmol/mol) (both inclusive)
             for subjects treated with oral antidiabetic drug (OAD) monotherapy and between 7.0%
             and 10.5% (53-91 mmol/mol) (both inclusive) for subjects treated with diet and
             exercise therapy at screening

          -  Japanese subjects diagnosed with type 2 diabetes who are: a) on stable OAD monotherapy
             at a half-maximum dose or below according to the approved Japanese labelling in
             addition to diet and exercise therapy for at least 30 days prior to screening (week
             -8) (For metformin only: the maximum dose of 750 mg/day is allowed except for
             METGLUCO®. For METGLUCO®, the allowable half-max dose of 1125 mg/day must be
             applied.). 'Stable' is defined as unchanged medication and unchanged dose, or b) on
             stable diet and exercise therapy for at least 30 days prior to screening (week -2)

        Exclusion Criteria:

          -  Female who is pregnant, breast-feeding or intends to become pregnant or is of
             child-bearing potential and not using an adequate contraceptive method (e.g.
             abstinence, diaphragm, condom [by the partner], intrauterine device, sponge,
             spermicide or oral contraceptives) throughout the trial including the 5-week follow-up
             period

          -  Treatment with once-weekly glucagon-like peptide-1 (GLP-1) receptor agonists within 90
             days prior to screening

          -  Treatment with any glucose lowering agent(s) (except for pre-trial OAD for subject
             treated with OAD monotherapy) in a period of 60 days prior to screening. An exception
             is short-term treatment (7 days or less in total) with insulin in connection with
             inter-current illness

          -  Any disorder which, in the opinion of the investigator, might jeopardise subject's
             safety or compliance with the protocol

          -  History of chronic or idiopathic acute pancreatitis

          -  Screening calcitonin value of 50 ng/L (pg/mL) or greater

          -  Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine
             neoplasia syndrome type 2 (MEN2)

          -  Impaired renal function defined as estimated glomerular filtration rate (eGFR) less
             than 60 ml/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4
             variable version)

          -  Acute coronary or cerebrovascular event within 90 days before randomisation

          -  Heart failure, New York Heart Association (NYHA) class IV