Completed PHASE2 INTERVENTIONAL 2-arm NCT04150107

A Study to Compare ORMD-0801 Once Daily to ORMD-0801 Three Times Daily in Subjects With Type 1 Diabetes

A Phase 2 Randomized, Open Label Crossover Study to Compare ORMD-0801 Given Once Daily at Bedtime to ORMD-0801 Given Three Times Daily (45-90 Minutes Before Meals) in Subjects With Type 1 Diabetes

Sponsor: Integrium

Conditions Type 1 Diabetes

Interventions ORMD-0801 Treatment A ORMD-0801 Treatment B Placebo

Updated 8 times since 2019 Last updated: May 7, 2022 Started: Oct 17, 2019 Primary completion: Feb 6, 2020 Completion: Mar 12, 2020

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Type 1 Diabetes and is currently completed. Integrium leads this study, which shows 8 recorded versions since 2019 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

8 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Jul 2022 — Jul 2024 [monthly]

Completed PHASE2

Status: Recruiting → Completed
Mar 2022 — Jul 2022 [monthly]

Recruiting PHASE2

Status: Unknown Status → Recruiting
Jan 2022 — Mar 2022 [monthly]

Unknown Status PHASE2

Status: Recruiting → Unknown Status

▶ Show 3 earlier versions

Jan 2021 — Jan 2022 [monthly]

Recruiting PHASE2
Apr 2020 — Jan 2021 [monthly]

Recruiting PHASE2
Dec 2019 — Apr 2020 [monthly]

Recruiting PHASE2

First recorded

Oct 2019

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Integrium
Oramed, Ltd.

Data source: Oramed, Ltd.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Tustin, United States