Clinical trial NCT02773381 (phase 1, 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, aged 18-75 years (both inclusive) at the time of signing informed
             consent

          -  Subjects diagnosed with type 2 diabetes mellitus for at least 90 days prior to the day
             of screening.

          -  Treated with diet and exercise and/or metformin monotherapy. The metformin dose should
             be unchanged in a period of 30 days prior to screening

          -  Body mass index (BMI) between 20.0-38 kg/m^2 (both inclusive)

          -  HbA1c (glycosylated haemoglobin) between 6.0-9.0 % (both inclusive)

        Exclusion Criteria:

          -  Female who is pregnant, breast-feeding or intends to become pregnant or is of
             child-bearing potential and not using adequate contraceptive methods (adequate
             contraceptive measures as required by local regulation or practice)

          -  Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary
             Thyroids Carcinoma

          -  History of pancreatitis (acute or chronic)

          -  Presence of clinically significant or symptoms of gastrointestinal disorders
             potentially affecting absorption of drugs and/or nutrients, as judged by the
             investigator

          -  History of major surgical procedures involving the stomach potentially affecting
             absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy,
             gastric bypass surgery)

          -  History or presence of any clinically relevant respiratory, metabolic (including
             dyslipedimia, however mild dyslipidaemia, defined as screening total cholesterol below
             or equal to 7.8 mmol/L and screening triglyceride below or equal to 3.42 mmol/L is
             accepted), renal, hepatic, gastrointestinal, endocrinological conditions (except
             conditions associated with diabetes mellitus)

          -  History or presence of malignant neoplasms within the last 5 years (except basal and
             squamous cell skin cancer and in-situ carcinomas)

          -  History or presence of cardiovascular disease including stable and unstable angina,
             myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation,
             clinically significant arrhythmias and conduction disorders

          -  Renal impairment with estimated Glomerular Filtration Rate (eGFR) below 60 mL /min as
             defined by CKD-EPI using IDMS for serum creatinine measurement on the day of screening

          -  Impaired liver function, defined as ALT above or equal to 2.5 times upper normal limit
             (UNL) on the day of screening

          -  Smoker (defined as a subject who is smoking more than 1 cigarette or the equivalent
             per day). During the in-patient period, the subject must be willing to completely
             refrain from smoking and use of nicotine substitute products

          -  Known or suspected alcohol abuse within 1 year from screening (defined as regular
             intake of more than 21 units weekly for men and 14 units weekly for women - one unit
             of alcohol equals about 300 mL of beer or lager, one glass (100 mL) of wine, or 25 mL
             spirits)