NCT07271251CompletedPhase 3
A Study Investigating Clinical Comparability of Two Formulations of Oral Semaglutide in Japanese Participants With Type 2 Diabetes
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 267
- Locations
- 15
- Primary Endpoint
- Change in glycated haemoglobin (HbA1c).
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Oral semaglutide
Experimental
Participants will receive oral semaglutide once daily.
Intervention: Oral semaglutide (Drug)
Oral semaglutide D
Experimental
Participants will receive oral semaglutide D once daily.
Intervention: Oral semaglutide (Drug)
Outcomes
Primary Outcomes
Change in glycated haemoglobin (HbA1c).
Time Frame: From baseline (week 0) to end of treatment (week 20)
Measured in percentage (%)-point.
Secondary Outcomes
- Change in body weight(From baseline (week 0) to end of treatment (week 20))
- Change in body weight(From baseline (week 0) to end of treatment (week 20))
- Number of treatment emergent adverse events (TEAEs)(From baseline (week 0) to end of study (week 25))
Investigators
Study Sites (15)
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