NCT03180710

A Trial to Investigate the Dose-linearity of BioChaperone® Combo 75/25 and the Safety at Three Different Doses in Subjects With Type 2 Diabetes

A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-linearity of BioChaperone® Combo 75/25 and the Safety at Three Different Doses in Subjects With Type 2 Diabetes

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Adocia · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a bicentric, double-blinded, randomised, four-period crossover phase 1 trial, using automated 30-hour euglycemic clamp in subjects with type 2 diabetes mellitus.

Detailed description

This is a bicentric, double-blinded, randomised, four-period crossover phase 1 trial, using automated 30-hour euglycemic clamp in subjects with type 2 diabetes mellitus. Each subject will be randomly allocated to a sequence of four treatments, three single doses of BioChaperone® Combo 75/25 (0.6 U/kg, 0.8 U/kg or 1.0 U/kg) and one single dose of Humalog® Mix25 at 0.8 U/kg on four separate dosing visits. Subjects will come in a fasted state to the clinical trial centre in the morning of each dosing day and stay at the clinical trial centre until the 30-hour clamp procedures have been terminated.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	BioChaperone® Combo 75/25 at 0.6 U/kg	Injection of BioChaperone® Combo 75/25 at 0.6 U/kg
DRUG	BioChaperone® Combo 75/25 at 0.8 U/kg	Injection of BioChaperone® Combo 75/25 at 0.8 U/kg
DRUG	BioChaperone® Combo 75/25 at 1.0 U/kg	Injection of BioChaperone® Combo 75/25 at 1.0 U/kg
DRUG	Humalog® Mix25 at 0.8 U/kg	Injection of Humalog® Mix25 at 0.8 U/kg

Timeline

• Start date: 2017-06-06
• Primary completion: 2017-08-28
• Completion: 2017-12-21
• First posted: 2017-06-08
• Last updated: 2018-01-10

Locations

2 sites across 1 country: Germany