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ORMD-0801 Dose 1 for Diabetes

Phase 2
Waitlist Available
Led By Joel M Neutel, M.D.
Research Sponsored by Oramed, Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline-study day -7 (± 1 day) through study day 1 (± 1 day), and week 4 -study day 22 (± 1 day) through study day 29 (± 1 day)
Awards & highlights

Study Summary

Randomized, double-blind, placebo-controlled, parallel group study.

Eligible Conditions
  • Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline-study day -7 (± 1 day) through study day 1 (± 1 day), and week 4 -study day 22 (± 1 day) through study day 29 (± 1 day)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline-study day -7 (± 1 day) through study day 1 (± 1 day), and week 4 -study day 22 (± 1 day) through study day 29 (± 1 day) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Measure of the Mean Night Time Glucose Levels Based on Two Nights of Glucose Measurements.
Secondary outcome measures
Measure Percent Change in Continuous Glucose Monitoring Mean Fasting Glucose Between Treatment and Run-In
Measure the Change From Baseline to End of the Study of Morning Fasting C-Peptide (Nmol/L)
The Effect of ORMD-0801 on Mean 24-hour Glucose
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: ORMD-0801 Dose 2 = 1.5 * Dose 1Experimental Treatment1 Intervention
three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1
Group II: ORMD-0801 Dose 1Experimental Treatment1 Intervention
three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo
Group III: Placebo ComparatorPlacebo Group1 Intervention
three identical capsules containing placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin human
FDA approved

Find a Location

Who is running the clinical trial?

IntegriumIndustry Sponsor
25 Previous Clinical Trials
5,087 Total Patients Enrolled
Oramed, Ltd.Lead Sponsor
13 Previous Clinical Trials
2,263 Total Patients Enrolled
Joel M Neutel, M.D.Principal InvestigatorOrange County Research Center
~19 spots leftby Jun 2025
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