← Back to Search

Other

ORMD-0801 for Type 2 Diabetes

Phase 3
Waitlist Available
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 and week 26
Awards & highlights
Pivotal Trial

Summary

This trial tests a new diabetes medication, ORMD-0801, in people with type 2 diabetes who haven't had success with diet or metformin. The medication is taken as a nightly capsule and aims to help control blood sugar levels. The study will monitor participants for several months to see how well the medication works. ORMD-0801 is an oral insulin formulation being tested for its safety and efficacy in managing blood sugar levels in type 2 diabetes patients.

Eligible Conditions
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 26
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 26 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean change in A1C
Secondary study objectives
The mean change in fasting plasma glucose

Side effects data

From 2016 Phase 2 trial • 188 Patients • NCT02496000
2%
Serious Non-Treatment Emergent Adverse Event
100%
80%
60%
40%
20%
0%
Study treatment Arm
ORMD-0801 Dose 1
Placebo Comparator
ORMD-0801 Dose 2 = 1.5 * Dose 1

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ORMD-0801Experimental Treatment1 Intervention
ORMD-0801 8 mg QD
Group II: PlaceboPlacebo Group1 Intervention
placebo dosed QD
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ORMD-0801
2015
Completed Phase 2
~240

Find a Location

Who is running the clinical trial?

IntegriumIndustry Sponsor
25 Previous Clinical Trials
4,928 Total Patients Enrolled
Oramed, Ltd.Lead Sponsor
13 Previous Clinical Trials
2,104 Total Patients Enrolled
Miriam Kidron, PhDStudy ChairOramed, Ltd.
3 Previous Clinical Trials
747 Total Patients Enrolled
~74 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top