CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
ORMD-0801 capsules- 2x8mg +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02535715
NCT02535715Phase 2Completed

A Euglycemic Insulin Clamp Study in Type 1 Diabetic Patients With Oral Insulin (ORAMED)

The University of Texas Health Science Center at San Antonio·interventional·Posted Aug 31, 2015·Updated Mar 21, 2019

In Brief

A Phase 2 clinical trial evaluating ORMD-0801 capsules- 2x8mg, ORMD-0801 capsules- 3x8mg, and 1 other intervention for Type 1 Diabetes. Completed, enrolled 11 participants across 1 site.

Detailed Summary

ORAMED has developed an oral insulin that, in preliminary studies, has shown promise. In the present study investigators will perform a pharmacodynamic/pharmacokinetic study to evaluate this novel insulin preparation as a potential therapeutic option in diabetic patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesUnited States
CollaboratorsOramed, Ltd.

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 31, 2015
Enrollment StartJan 1, 2015
Primary CompletionApr 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.8 years ago

Interventions

ORMD-0801 capsules- 2x8mgdrug

Participants who receive this intervention first, then receive either ORMD-0801- 3x8mg or 1x16mg dose after a 3 day to 4 week interval. Participants receiving this drug as the second drug intervention will then receive the third intervention after a 3 day to 4 week interval. ORMD-0801 capsules are an oral insulin that has shown promise in preliminary studies. Investigators will evaluate this novel insulin preparation as a potential therapeutic option in diabetic patients.

ORMD-0801 capsules- 3x8mgdrug

Participants who receive this intervention first, then receive either ORMD-0801- 2x8mg or 1x16mg dose after a 3 day to 4 week interval. Participants receiving this drug as the second drug intervention will then receive the third intervention after a 3 day to 4 week interval. ORMD-0801 capsules are an oral insulin that has shown promise in preliminary studies. Investigators will evaluate this novel insulin preparation as a potential therapeutic option in diabetic patients.

ORMD-0801 capsules- 1x16mgdrug

Participants who receive this intervention first, then receive either ORMD-0801- 2x8mg or 3x8mg dose after a 3 day to 4 week interval. Participants receiving this drug as the second drug intervention will then receive the third intervention after a 3 day to 4 week interval. ORMD-0801 capsules are an oral insulin that has shown promise in preliminary studies. Investigators will evaluate this novel insulin preparation as a potential therapeutic option in diabetic patients.