Phase 2
Completed N=11
A Euglycemic Insulin Clamp Study in Type 1 Diabetic Patients With Oral Insulin (ORAMED)
Source: ClinicalTrials.gov NCT02535715 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Hepatic Glucose Production (Co-primary Outcome) — 2.0; 2.0; 2.1; 1.8 mg/kg-minute
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.
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 |
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
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. Informational only — not medical advice.