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

PHASE2CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

January 31, 2015

Primary Completion Date

April 30, 2017

Study Completion Date

April 30, 2017

Conditions
Type 1 Diabetes
Interventions
DRUG

ORMD-0801 capsules- 2x8mg

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.

DRUG

ORMD-0801 capsules- 3x8mg

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.

DRUG

ORMD-0801 capsules- 1x16mg

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.

Trial Locations (1)

78229

The University of Texas Health Science Center at San Antonio, San Antonio

All Listed Sponsors
collaborator

Oramed, Ltd.

INDUSTRY

lead

The University of Texas Health Science Center at San Antonio

OTHER

NCT02535715 - A Euglycemic Insulin Clamp Study in Type 1 Diabetic Patients With Oral Insulin (ORAMED) | Biotech Hunter | Biotech Hunter