Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD (Oral Antidiabetic Drug) in Japanese Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Semaglutide; Dulaglutide
Intervention description: Oral administration once-daily, as add-on to pre-trial oral antidiabetic drug (OAD).; Subcutaneously administration (s.c., under the skin) once-weekly, as add-on to pre-trial oral antidiabetic drug (OAD).
Intervention MeSH terms: Dulaglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 458.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. The aim of this trial is to investigate Safety and efficacy
      of oral semaglutide versus dulaglutide both in combination with one OAD (oral antidiabetic
      drug) in Japanese subjects with type 2 diabetes.
    

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

          -  Japanese male or female, age above or equal to 20 years at the time of signing
             informed consent

          -  Diagnosed with type 2 diabetes mellitus for at least 60 days prior to day of screening

          -  HbA1c (glycosylated haemoglobin) between 7.0%-10.5% (53-91 mmol/mol) (both inclusive)

          -  OAD (oral antidiabetic drug) monotherapy with stable daily dose for at least 60 days
             prior to the day of screening of one of SU (sulphonylurea) glinide , TZD
             (thiazolidinedione), α-GI (alpha-glucosidase inhibitor) or SGLT-2 (sodium-glucose
             cotransporter-2) inhibitor according to Japanese labelling

        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 measures are abstinence (not having sex), diaphragm, condom (by the
             partner), intrauterine device, sponge, spermicide or oral contraceptives

          -  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 potentially affecting
             absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy,
             gastric bypass surgery)

          -  Any of the following: myocardial infarction, stroke or hospitalisation for unstable
             angina or transient ischaemic attack (TIA) within the past 180 days prior to the day
             of screening and randomisation

          -  Subjects presently classified as being in New York Heart Association (NYHA) Class IV

          -  Planned coronary, carotid or peripheral artery revascularisation known on the day of
             screening

          -  Subjects with alanine aminotransferase (ALT) above 2.5 x upper normal limit (UNL)

          -  Renal impairment defined as estimated glomerular filtration rate (eGFR) below 30
             mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula
             (CKD-EPI)

          -  Treatment with once-weekly glucagon-like peptide-1 receptor agonists (GLP-1 RA) or
             once weekly dipeptidyl peptidase-4 (DPP-4) inhibitor in a period of 90 days before the
             day of screening

          -  For subjects treated with an OAD other than TZD at screening: Treatment with TZD in a
             period of 90 days before the day of screening

          -  Treatment with any medication for the indication of diabetes or obesity in addition to
             background OAD medication (SU, glinide, TZD, α-GI or SGLT-2 inhibitor) in a period of
             60 days before the day of screening with the exception of short-term insulin treatment
             for acute illness for a total of at least 14 days

          -  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 in situ carcinomas)

          -  History of diabetic ketoacidosis