NCT03938740

Comparison of Different Insulin Dosing Algorithms Using Hepatic Directed Vesicle-Insulin Lispro and Insulin Degludec

An Exploratory Randomized Open-Label 2-Arm Comparison of Insulin Dosing Algorithms Using Hepatic Directed Vesicle-Insulin Lispro and Insulin Degludec to Determine Optimum Basal Insulin Dosing Regimens in Type 1 Diabetes Mellitus Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Diasome Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Multi-center, open-label, multiple dose safety, tolerability and efficacy study

Detailed description

This is a 24-week, open-label, multiple dose safety, tolerability and efficacy study. There is a 12-week run-in phase when all subjects receive Insulin Lispro and Insulin Degludec for 12 weeks. After completing the run-in period, subjects then are randomized to a treatment group of either HDV- Insulin lispro + Insulin Degludec (Degludec dose reduced by 40%) or HDV-Insulin lispro+ Insulin Degludec (Degludec dose reduced by 10%) for 12 weeks of treatment.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	HDV-Insulin Lispro and Insulin Degludec (-40%)	HDV-Insulin Lispro and Insulin Degludec (-40%)
DRUG	HDV-Insulin Lispro and Insulin Degludec (-10%)	HDV-Insulin Lispro and Insulin Degludec (-10%)

Timeline

• Start date: 2019-03-18
• Primary completion: 2019-12-06
• Completion: 2020-03-18
• First posted: 2019-05-06
• Last updated: 2020-04-02

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study