Conditions: Diabetes Mellitus Type 2
Keywords: Oral Insulin Diabetes Mellitus Type 2 Safety Pharmacodynamics Pharmacokinetics
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 30
Healthy volunteers: no

Brief summary:
The purpose of this study is to test the safety and pharmacodynamics of an oral formulation of insulin in subjects with Type 2 Diabetes.

Detailed description:
This is a single-center, Phase II(a), randomized, double-blind, placebo-controlled, parallel group, inpatient study preceded by a 5-day single-blind outpatient placebo run-in period.

Arms:
arm 1: Oral Insulin Formulation arm 2: Oral Insulin Formulation arm 3: Oil Capsules

Interventions: intervention 1: ORMD-0801 Dose # 1 intervention 2: ORMD-0801 Dose # 2 intervention 3: Placebo
Intervention descriptions: intervention 1: Oral Insulin Formulation intervention 2: Oral Insulin Formulation intervention 3: Oil Capsules

Protocol document: