Phase 2 N=11 Treatment

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

Type 1 Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT02535715 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2019

Primary outcome: Primary: Hepatic Glucose Production (Co-primary Outcome) — 2.0; 2.0; 2.1; 1.8 mg/kg-minute

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ORMD-0801 capsules- 2x8mg (Drug); ORMD-0801 capsules- 3x8mg (Drug); ORMD-0801 capsules- 1x16mg (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The University of Texas Health Science Center at San Antonio
Primary completion: Apr 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Hepatic Glucose Production (Co-primary Outcome)	2.0; 2.0; 2.1; 1.8; 1.9; 2.1	—
SECONDARY Plasma Insulin Concentrations	9; 8; 7; 9; 8; 7	—
SECONDARY Plasma Glucose Concentrations	109; 120; 123; 98; 110; 115	—
SECONDARY Plasma Glucagon Concentrations	29; 37; 37; 29; 38; 36	—
SECONDARY Plasma Free Fatty Acid Concentrations	380; 402; 410; 408; 465; 467	<0.05 sig

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.

Eligibility Criteria

Inclusion Criteria

Must be between 18 and 70 years of age
Must have type 1 diabetes
Must be in good general health by routine history and physical exam
A1c 10.0%
BMI 40 kg.m2
On medications known to affect glucose metabolism other than insulin
Hematocrit ≤ 34 vol%
Liver Function Tests >3 x Upper Normal Limit
Plasma creatinine > 1.8 mg/dl

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02535715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.