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Erythromycin Ethylsuccinate Suspension for Type 1 Diabetes

Phase 1
Waitlist Available
Led By Adil E Bharucha, MBBS, MD
Research Sponsored by Adil Bharucha
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 11 days
Awards & highlights

Summary

With this study, the investigators hoped to learn if the rate at which food empties from the stomach affects blood sugar values. Using data from this study, we hope to improve our ability to control blood sugars in individuals with type 1 diabetes mellitus.

Eligible Conditions
  • Type 1 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~11 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 11 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Relationship between gastric emptying and glycemia

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Erythromycin lactobionate IV 2 mg/kgExperimental Treatment2 Interventions
During the second visit, erythromycin was given as an initial bolus of 0.5 mg/kg over 10 min immediately before the meal. The subject consumed the test meal containing 13C-Spirulina in no more than 10 minutes. Breath samples were collected at baseline obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Thereafter, an infusion of 1.5 mg/kg was given over the next 50 min with the same infusion pump.
Group II: Erythromycin Ethylsuccinate SuspensionExperimental Treatment2 Interventions
In Phase 2 of the study, subjects randomized to this arm will receive Erythromycin Ethylsuccinate Suspension 250 mg tid orally for a total period of 7 days. The GEBT was performed approximately on day 7. The subject consumed the test meal containing 13C-Spirulina in no more than 10 minutes. Breath samples were collected at baseline obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points.
Group III: Erythromycin lactobionate IV 3 mg/kgActive Control2 Interventions
During the second visit, erythromycin was given as an initial bolus of 0.5 mg/kg over 10 min immediately before the meal. The subject consumed the test meal containing 13C-Spirulina in no more than 10 minutes. Breath samples were collected at baseline obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points.Thereafter, an infusion of 1.5 mg/kg was given over the next 50 min with the same infusion pump.
Group IV: Placebo SuspensionPlacebo Group2 Interventions
In Phase 2 of the study, subjects randomized to this arm will receive an oral placebo prepared to mimic the Erythromycin Ethylsuccinate Suspension for a total period of 7 days. The GEBT was performed approximately on day 7. The subject consumed the test meal containing 13C-Spirulina in no more than 10 minutes. Breath samples were collected at baseline obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points.
Group V: Placebo IVPlacebo Group2 Interventions
Saline was given as an initial bolus over 10 min immediately before the meal. The subject consumed the test meal containing 13C-Spirulina in no more than 10 minutes. Breath samples were collected at baseline obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Thereafter, an infusion of saline was given over the next 50 min with the same infusion pump.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Erythromycin
FDA approved
Spirulina platensis
Not yet FDA approved
Lactobionic acid
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Adil BharuchaLead Sponsor
1 Previous Clinical Trials
24 Total Patients Enrolled
Adil E Bharucha, MBBS, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
105 Total Patients Enrolled
~2 spots leftby Sep 2025
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