At a glance
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A Randomized, Double Blind, Phase 2b Study to Evaluate the Effect of ORMD-0801 Compared to Placebo on Endogenous Glucose Production in Patients With Type 2 Diabetes Mellitus
In Brief
A Phase 2 clinical trial evaluating ORMD-0801 and Placebo for Diabetes Mellitus, Type 2. Completed, enrolled 49 participants across 1 site.
Detailed Summary
This study is designed to explore the efficacy of ORMD-0801 compared to placebo on endogenous glucose production in subjects with type 2 diabetes (T2DM). Subjects will undergo an initial Screening Visit (Visit 0) to establish their eligibility to participate in the study. At Visit 1 (2 weeks after the Screening Visit), qualifying subjects will be randomized to either ORMD-0801 (8 mg) or matching placebo, study medication will be dispensed and subjects will dose, twice a day, once in the morning prior to breakfast and once at night prior to bedtime
Study Details
Timeline
Interventions
8 mg capsules of ORMD-0801 (Oral Insulin)
Placebo capsule (Fish Oil)