Conditions: Diabetes Type 2
Keywords: Diabetes Mellitus type 2 Metformin oral insulin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 188
Healthy volunteers: no

Brief summary:
Randomized, double-blind, placebo-controlled, parallel group study.

Detailed description:
This is a multicenter, Phase II, randomized, double-blind, placebo-controlled, parallel group study. After appropriate screening, approximately 180 male and female patients from up to 33 study centers will be treated in this study. Patients with type 2 diabetes mellitus who are being treated by diet, exercise, untreated with antidiabetic medications or treated with and metformin monotherapy or in combination with one other antidiabetic drug (excluding insulin) are eligible for enrollment.

Arms:
arm 1: three identical capsules containing placebo arm 2: three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo arm 3: three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1

Interventions: intervention 1: ORMD-0801 intervention 2: Placebo Comparator
Intervention descriptions: intervention 1: Oral Insulin intervention 2: Placebo

Protocol document: