Clinical trial NCT02305381 (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, placebo
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, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria: - Male or female, age at least 18 years at the time of signing inform
        consent. For Japan: Male or female, age at least 20 years at the time of signing informed
        consent - Subjects diagnosed with T2DM (type 2 diabetes mellitus) and on stable diabetes
        treatment (plus/minus 20 percent change in total daily dose) with basal insulin (minimum of
        0.25 IU/kg/day and/or 20 IU/day of: insulin glargine, insulin detemir, insulin degludec
        and/or NPH insulin) alone or in combination with metformin (minimum of 1500 mg/day or
        maximal tolerable dose) for 90 days prior to screening - HbA1c (glycosylated haemoglobin)
        7.0 - 10.0 percent (53 - 86 mmol/mol) both inclusive 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 throughout the trial including the 5 weeks
        follow-up period (adequate contraceptive measures as required by local regulation or
        practice). Germany: Only highly effective methods of birth control are accepted (ie one
        that results in less than 1% per year failure rate when used consistently and correctly
        such as implants, injectables, combined oral contraceptives, some intrauterine device), or
        sexual abstinence or vasectomised partner. Japan: Adequate contraceptive measures are
        abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device,
        sponge, spermicide or oral contraceptives - Treatment with any glucose lowering agents
        other than stated in the inclusion criteria in a period of 90 days before screening. An
        exception is short-term treatment (7 days or less in total) with bolus insulin in
        connection with intercurrent illness - Experienced more than 3 episodes of severe
        hypoglycaemia within 6 months prior to screening, and/or hypoglycaemia unawareness -
        History of pancreatitis (acute or chronic) - 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 2 (MEN 2) - Severe renal impairment defined as eGFR
        (estimated glomerular filtration rate) 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 - Heart failure, New York Heart Association (NYHA)
        Class IV