Type 2 Diabetes
Conditions
Brief summary
The purpose of the study is to find out if the new tablet formulation oral semaglutide D is equally safe and effective as the approved oral semaglutide for treating Japanese people with type 2 diabetes. Participants will receive either oral semaglutide D (the treatment being tested) or oral semaglutide (the comparator); which treatment a participant gets is decided by chance. Oral semaglutide is an approved tablet (a treatment used as a comparator), while oral semaglutide D is described as the new tablet formulation being tested in this study. The study will last approximately 27 weeks.
Interventions
DRUGOral semaglutide
Semaglutide will be administered orally once daily.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * Japanese male or female. * Age 18 years or above at the time of signing the informed consent. * Diagnosed with type 2 diabetes (T2D) greater than or equal to (≥) 90 days prior to day of screening. * Glycated haemoglobin (HbA1c) of 7.0-10.5 percent (%) (53-91 millimoles per mole \[mmol /mol\]) (both inclusive) at screening. * Stable daily dose(s) ≥ 60 days before screening with any 1-2 of the following oral antidiabetic drugs (OADs): Sulfonylurea (SU), glinide, thiazolidinedione (TZD), alpha-glucosidase inhibitor (α-GI), sodium-glucose cotransporter 2 (SGLT-2) inhibitor or metformin (effective or maximum tolerated dose as judged by the investigator) according to Japanese labelling.
Exclusion criteria
* Known or suspected hypersensitivity to study intervention(s) or related products. * Previous participation in this study. Participation is defined as signed informed consent. * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method. * Current participation (i.e., signed informed consent) in any other interventional clinical study. * Exposure to an investigational medicinal product within 90 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening. * Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol. * Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. * Anticipated initiation or change in concomitant medications for more than 14 consecutive days affecting weight or glucose metabolism. * Use of any medication with unknown or unspecified content within 90 days before screening. * Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. * Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator. * History or presence of pancreatitis (acute or chronic). * History of major surgical procedures involving the stomach potentially affecting absorption of study products or current presence of gastrointestinal implant. * Myocardial infarction, stroke, transient ischaemic attack or hospitalization for unstable angina pectoris within 60 days before screening. * Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening. * Planned coronary, carotid or peripheral artery revascularisation. * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified within 90 days before screening or in the period between screening and randomisation. * Impaired liver function, defined as Alanine Aminotransferase (ALT) ≥ 2.5 times or Bilirubin \>1.5 times upper normal limit at screening. * Renal impairment with estimated glomerular filtration rate (eGFR) less than (\<) 30 millilitres per minute per meter square (mL/min/1.73 m\^2) as per 2021 Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI) formula (by creatinine) at screening. * Treatment with medication for diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed. * Presence or history of malignant neoplasms or in situ carcinomas within 5 years before screening. * Any episodes of diabetic ketoacidosis within 90 days before screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in glycated haemoglobin (HbA1c). | From baseline (week 0) to end of treatment (week 20) | Measured in percentage (%)-point. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight | From baseline (week 0) to end of treatment (week 20) | Measured in Kilogram (Kg). |
| Number of treatment emergent adverse events (TEAEs) | From baseline (week 0) to end of study (week 25) | Measured as count of events. |
Countries
Japan
Contacts
STUDY_DIRECTORClinical Transparency dept. 2834
Novo Nordisk A/S
Outcome results
None listed