Efficacy of mitemcinal, a motilin agonist, on gastrointestinal symptoms in patients with symptoms suggesting diabetic gastropathy: a randomized, multi-center, placebo-controlled trial.
BACKGROUND
Mitemcinal, an oral motilin agonist, accelerates gastric emptying.


OBJECTIVE
To investigate if mitemcinal was superior to placebo in relief of symptoms attributed to gastroparesis.


METHODS
In a randomized, double-blind design, 392 insulin-requiring diabetics with symptoms attributable to gastroparesis were treated for 3 months with placebo, mitemcinal 5 or 10 mg bid. On a weekly basis, patients assessed whether there was adequate relief of their gastroparesis symptoms. Patients were classified as Complete Responders (CR) if there were three consecutive positive monthly responses, which required at least 50% of their weekly responses in a month being positive. An Overall Responder (OR) had at least 75% positive weekly responses for the whole treatment period.


RESULTS
Mitemcinal 10 mg produced a significantly better response rate than placebo with a 10.6% increase in the OR (P < 0.05 vs. placebo). Mitemcinal 10 mg also produced statistically significant increases in the CR and OR in the subgroup identified by baseline body mass index (<35 kg/m(2)) and haemoglobin A(1c) (<10%) (P < 0.01 vs. placebo). Adverse events did not differ from placebo frequency levels.


CONCLUSIONS
Mitemcinal can induce a statistically significant response to treatment in a subset of diabetic gastroparesis where future prokinetic clinical trials should be focused.
McCallum
R W
RW
Center for GI Nerve and Muscle Function, University of Kansas Medical Center, Kansas City, KS 56160, USA. shinshiosm@chugai-pharm.co.jp
Cynshi
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D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D018589:Gastroparesis / Q000188:drug therapy*; D006801:Humans; D008297:Male; D009037:Motilin / Q000493:pharmacokinetics / Q000627:therapeutic use*; D012449:Safety; D016896:Treatment Outcome
D005765:Gastrointestinal Agents; D009037:Motilin