Clinical trial NCT03021187 (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, 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, 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, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria: - Informed consent obtained before any trial-related activities.
        Trial-related activities are any procedures that are carried out as part of the trial,
        including activities to determine suitability for the trial. - Male or female, age above or
        equal to 18 years at the time of signing informed consent. For Japan only: Male or female,
        age above or equal to 20 years at the time of signing informed consent. - Diagnosed with
        type 2 diabetes mellitus 90 days or more prior to the day of screening. - HbA1c
        (glycosylated haemoglobin) of 7.0-9.5% (53-80 mmol/mol) (both inclusive). - Stable
        treatment with one of the following insulin regimens (minimum 10 IU/day) 90 or more days
        prior to the day of screening. Maximum 20% change in total daily dose is acceptable: (1)
        Basal insulin alone or (2) Basal and bolus insulin in any combination or (3) Premixed
        insulin including combinations of soluble insulins 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 (adequate contraceptive measure as required by
        local regulation or practice). For Greece only: adequate contraceptive measures are defined
        as combined hormonal contraception (containing oestrogen and progesterone), which suppress
        ovulation (oral, intravaginal, percutaneous), progesterone-only hormonal contraception
        which suppress ovulation (oral, injectable, implantable), intrauterine device,
        hormone-releasing intrauterine system, bilateral tubal occlusion, partner with vasectomy,
        sexual abstinence. For Japan only: Adequate contraceptive measures are abstinence (not
        having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or
        oral contraceptives. For Canada only: adequate contraceptive measures are defined as
        combined hormonal contraception (containing oestrogen and progesterone), which suppress
        ovulation (oral, intravaginal, percutaneous), progesterone-only hormonal contraception
        which suppress ovulation (oral, injectable, implantable), intrauterine device,
        hormone-releasing intrauterine system, bilateral tubal occlusion, partner with vasectomy,
        sexual abstinence - Any disorder, which in the investigator's opinion might jeopardise
        subject's safety or compliance with the protocol. - Family or personal history of Multiple
        Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC). - History of
        pancreatitis (acute or chronic). - History of major surgical procedures involving the
        stomach and potentially affecting absorption of trial product (e.g. subtotal and total
        gastrectomy, sleeve gastrectomy, gastric bypass surgery). - Any of the following:
        myocardial infarction (MI), stroke or hospitalisation for unstable angina or transient
        ischaemic attack within the past 180 days prior to the day of screening and randomisation.
        - Classified as being in New York Heart Association (NYHA) Class IV. - Planned coronary,
        carotid or peripheral artery revascularisation known on the day of screening. - Renal
        impairment defined as estimated Glomerular Filtration Rate (eGFR) less than 60 mL/min/1.73
        m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI). - Treatment
        with any medication for the indication of diabetes or obesity other than stated in the
        inclusion criteria in a period of 90 days before the day of screening. An exception is
        short-term change of insulin treatment for acute illness for a total of 14 days or less. -
        Known hypoglycaemic unawareness according to Clarke's questionnaire. - Proliferative
        retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or
        dilated fundoscopy performed within 90 days prior to randomisation. - History or presence
        of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer
        and carcinoma in situ). - Subjects with alanine aminotransferase (ALT) more than 2.5 x
        upper normal limit (UNL).