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Semaglutide 2017-02-02 ClinicalTrials

Oral Semaglutide Trial Investigates Efficacy and Safety in Insulin-Treated Type 2 Diabetes Mellitus

Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Insulin

Background

Type 2 Diabetes Mellitus (T2DM) is a progressive metabolic disorder often requiring multiple therapies to achieve glycemic control. Insulin therapy is a cornerstone for many T2DM patients, but often comes with challenges like weight gain and hypoglycemia. GLP-1 receptor agonists (GLP-1RAs) offer benefits beyond glycemic control, including weight loss and cardiovascular protection, but are traditionally injectable. Oral formulations, like oral semaglutide, represent a significant advancement, potentially improving patient adherence and quality of life. This trial addresses the specific gap of integrating an oral GLP-1RA into existing insulin regimens for T2DM patients.

Study Design

This global, randomized, placebo-controlled trial investigated oral semaglutide in subjects with Type 2 Diabetes Mellitus already receiving insulin therapy. Participants continued their pre-trial insulin regimen (basal, basal-bolus, or premixed, including combinations of soluble insulins) throughout the study. Subjects on metformin in addition to insulin also maintained their metformin treatment. The primary objective was to assess the efficacy and safety of oral semaglutide compared to placebo. Specific doses, treatment duration, and the total sample size for this particular trial are not detailed in the provided abstract.

Results

No specific efficacy or safety results are available in the provided abstract for this trial. The study aimed to evaluate changes in glycemic control and safety profiles, but quantitative findings, such as specific HbA1c reductions, body weight changes, or adverse event rates, are not disclosed in this preliminary information.


Source: clinicaltrials:NCT03021187 · Ingested 2026-07-02 · Digest: gemini-2.5-flash