TRIMEBUTINE IN DIABETIC GASTROPARESIS: DYNAMICS OF SYMPTOMS AND GLYCEMIC PARAMETERS BASED ON SELF-MONITORED BLOOD GLUCOSE IN PATIENTS WITH TYPE 2 DIABETES

Abstract

Objective: This prospective open-label pilot study aimed to evaluate the effect of trimebutine on gastroparesis symptoms and postprandial glycemic parameters based on self-monitored blood glucose in patients with type 2 diabetes mellitus (T2DM). Methods: Forty adults with T2DM (duration ≥5 years) and ≥2 typical symptoms of gastroparesis lasting ≥3 months were consecutively enrolled from an endocrinology/therapeutic department. All patients received trimebutine 200 mg three times daily for 4 weeks without planned changes in baseline antidiabetic therapy. Gastroparesis symptoms were assessed at baseline and week 4 using a modified 6‑item Gastroparesis Cardinal Symptom Index (total score 0–30). Self-monitored blood glucose diaries (fasting and 2‑hour post-breakfast values for 3 days) were obtained before treatment and at week 4 to calculate mean fasting glucose, 2‑hour postprandial glucose, and postprandial increment (ΔPPG). Results: Trimebutine is expected to produce a clinically relevant reduction in total symptom scores, mainly for postprandial fullness, early satiety, and bloating, and to reduce ΔPPG without worsening fasting glycemia. Conclusion: This pilot study will generate real‑world data on symptomatic and glycemic responses to trimebutine in T2DM with suspected gastroparesis and inform the design of larger controlled trials.​