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A research study to see if two different formulations of oral semaglutide are equally safe and effective in reducing the blood sugar level in Japanese people with type 2 diabetes

Basic Information

Recruitment status	Not Recruiting
Health condition(s) or Problem(s) studied	Type 2 diabetes
Date of first enrollment	01/12/2025
Target sample size	264
Countries of recruitment
Study type	Interventional
Intervention(s)	This is an interventional, multi-centre, randomised, open-label, phase 3 study, designed to confirm non-inferiority of change from baseline in HbA1c to week 20 of oral semaglutide D 4 mg to oral semaglutide 7 mg in Japanese participants with type 2 diabetes (T2D) as add-on to stable dose of 1 2 oral antidiabetic drug(s) (OADs).

Outcome(s)

Primary Outcome	Change From baseline to end of treatment in HbA1c (%)
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1. HbA1c of 7.0-10.5 % (53-91 mmol /mol) (both inclusive) at screening. 2. Stable daily dose(s) >= 60 days before screening with any 1-2 of the following OADs: SU, glinide, TZD, alpha-GI, SGLT-2 inhibitor or metformin (effective or maximum tolerated dose as judged by the investigator) according to Japanese labelling.
Exclude criteria	Previous or planned (during the study period) obesity treatment with surgery or a weight loss device.