Motilides: a long and winding road: lessons from mitemcinal (GM-611) on diabetic gastroparesis.

Mitemcinal (GM-611) is a macrolide motilin receptor agonist with acid-resistance and without antibiotic activity. Since ABT-229 (a first generation of motilin receptor agonist) had failed to demonstrate symptomatic relief in functional dyspepsia and diabetic gastroparesis, there is a controversy for which of prokinetics or relaxants is clinically beneficial. Currently, oral mitemcinal has been focused on diabetic gastroparesis under clinical development. It showed to accelerate gastric-emptying in diabetic animals and in patients with gastroparesis. The latest double-blind, placebo-controlled study demonstrated to be effective at improving diabetes-related gastroparesis symptoms. A sub-group analysis, which included patients with BMI < 35 kg/m2 and hemoglobin A1c < 10%, there were significantly more symptomatic relieves in the 10 mg mitemcinal group than in the placebo group. The frequency of adverse events did not differ between groups. Mitemcinal shows promise in the subset of patients who should be confirmed in future studies.

RCT Entities:   Population Interventions Outcomes