Clinical trial NCT02207374 (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, dpp-4 inhibitor
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, OC12CC3CC(C1)CC(C3)(C2)NCC(=O)N1CCC[C@H]1C#N
Eligibility criteria:

        Inclusion Criteria:

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

          -  HbA1c (glycosylated haemoglobin A1c) between 7.0% and 10.5% (53-91 mmol/mol) (both
             inclusive)

          -  Japanese subjects with type 2 diabetes mellitus (diagnosed clinically) and on stable
             treatment (defined as unchanged medication and unchanged dose) who are: a) on diet and
             exercise therapy for at least 30 days before Visit 1 (week -2). or b) on OAD
             monotherapy (either of SU (sulfonylurea), glinide, a-GI (a-glucosidase inhibitor) or
             TZD (thiazolidinediones)) within approved Japanese labelling in addition to diet and
             exercise therapy for at least 60 days before Visit 1 (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 [not having sex], diaphragm, condom [by the partner], intrauterine device,
             sponge, spermicide or oral contraceptives) throughout the trial including the 5 week
             follow-up period

          -  Treatment with glucose lowering agent(s) other than stated in the inclusion criteria
             within 60 days before Visit 1 (week -2) and treatment with once weekly glucagon-like
             peptide-1 (GLP-1) receptor agonists within 90 days before Visit 1 (week -2). An
             exception is short-term treatment (below or equal to 7 days 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 above or equal to 50 ng/L (pg/mL)

          -  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) below
             30 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 (Visit 2
             [week 0])

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