Lack of effect of intermittently administered sodium fusidate in patients with newly diagnosed type 1 diabetes mellitus: the FUSIDM trial.
OBJECTIVE
We evaluated in a double-blind study the effect of early treatment with the immunomodulatory drug fusidin in patients with newly diagnosed type 1 diabetes mellitus.


METHODS
Twenty-eight adults with newly diagnosed type 1 diabetes were included in the study. The patients were randomly assigned (computer-generated random number sequence) to two experimental groups. Patients allocated to the fusidin (FUS) group (n=15) received sodium fusidate (fusidin; 500 mg orally three times daily for 4 weeks). Subsequently the drug was given at the same dose and scheduled for two consecutive weeks a month followed by 2 weeks a month without the drug for 20 weeks. Subjects allocated to the placebo (PCB) group (n=13) received placebo according to the same schedule and conditions described for sodium fusidate in the FUS group. All patients received a diet adjusted to their age and BMI, and intensive insulin therapy.


RESULTS
There were no statistically significant differences between the FUS and PCB groups in beta cell function, evaluated by basal and glucagon-stimulated C-peptide values during the follow-up (24 and 48 weeks). There was also no difference between the two groups in insulin requirement after 48 weeks (0.4+/-0.2 and 0.4+/-0.2 U/kg body weight for the FUS and PCB groups, respectively). Antibody titres, including insulin autoantibodies, were similar in the two groups during the follow-up.


CONCLUSIONS
Early treatment of newly diagnosed type 1 diabetes patients with intermittently administered fusidin failed to influence the natural course of the disease.
Conget
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I
Endocrinology and Diabetes Unit, Hospital Clínic, 08036 Barcelona, Spain. iconget@clinic.ub.es
Aguilera
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Pellitero
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Näf
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Bendtzen
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Casamitjana
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Gomis
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Nicoletti
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D000328:Adult; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002096:C-Peptide / Q000097:blood; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005672:Fusidic Acid / Q000627:therapeutic use*; D006442:Glycated Hemoglobin / Q000032:analysis / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D007155:Immunologic Factors / Q000627:therapeutic use*; D007328:Insulin / Q000627:therapeutic use; D007515:Islets of Langerhans / Q000187:drug effects / Q000503:physiopathology; D008297:Male
D000900:Anti-Bacterial Agents; D002096:C-Peptide; D005672:Fusidic Acid; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007155:Immunologic Factors; D007328:Insulin