NCT06473662

Study to Evaluate the Safety and Efficacy of Oral Insulin Formulation in Type 2 Diabetes Mellitus Subjects

A Phase 2b, Open-label Randomized Comparative Study to Evaluate the Safety and Efficacy of Oral Insulin Formulation in Type 2 Diabetes Mellitus Subjects Uncontrolled With Metformin Hydrochloride Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Roger New · Industry
• Sex: All
• Age: 35 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study was to compare the pharmacodynamic properties of different doses of regular human insulin administered in capsule form twice daily in a randomised twelve-week open-label trial.

Conditions

• Type 2 Diabetes Treated With Insulin

Interventions

Type	Name	Description
DRUG	Oral insulin	Capsule administered by mouth with a glass of water two times per day, once before breakfast and once before supper

Timeline

• Start date: 2018-10-22
• Primary completion: 2020-07-11
• Completion: 2020-07-11
• First posted: 2024-06-25
• Last updated: 2025-02-06
• Results posted: 2025-02-06

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study