NCT02954601

A Study of Single and Multiple Doses of Oral Insulin or Placebo in Subjects With Type 2 Diabetes Mellitus

A Phase 2a, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Way Crossover Study to Compare Safety, Efficacy, and Pharmacodynamics of Single and Multiple Doses of ORMD-0801 in Adult Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Oramed, Ltd. · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a four-way crossover (non-parallel) study with each subject receiving three of the four arms. The study will enroll approximately 30 adult subjects with T2DM from age 20 to 75 inclusive. Following a 7-10 day Screening period, eligible subjects will enter a 3-day single-blind placebo run-in. On Day 4, each subject will be randomized to a treatment sequence that will include three treatment assignments for each of three treatment Periods according to the randomization scheme.

Detailed description

Following the screening, eligible subjects entered a 3-day, single-blind placebo run-in. On Day 4, each subject was randomized to a treatment sequence that included three treatment assignments for each of three treatment Periods according to the randomization scheme. Pre-assignment Details The number of participants receiving each Intervention, in each Period, is reported. Subjects received the randomized treatment from Day 4 through Day 8. There was a 24-hour single-blind placebo washout on Day 9. Each subject received placebo for one of the three treatment periods. Each subject also received 1 of the 3 active doses randomly in each of the two other treatment periods respectively. The dosing order is random.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	ORMD-0801 (qd)	Dose 1 = ORMD-0801 (qd)
DRUG	ORMD-0801 (bid)	Dose 2 = ORMD-0801 (bid)
DRUG	ORMD-0801 (tid)	Dose 3 = ORMD-0801 (tid)
OTHER	Placebo	fish oil placebo

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-02-24
• Completion: 2017-03-15
• First posted: 2016-11-03
• Last updated: 2018-07-12
• Results posted: 2018-07-12

Locations

1 site across 1 country: United States