NCT02514850

A Trial to Compare the Pharmacodynamic and Pharmacokinetic Properties of Biochaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes

A Randomised, Single Dose, Double-blind, Double-dummy, Three-period Cross-over Trial to Compare the Pharmacodynamic and Pharmacokinetic Properties of Biochaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Adocia · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This is a single centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over, euglycaemic clamp study in subjects with type 2 diabetes on stable insulin treatment. Each subject will be randomly allocated to a treatment sequence and will be administered single subcutaneous doses of 0.8 U/kg Biochaperone® Combo, 0.8 U/kg Humalog® Mix25 or simultaneous subcutaneous injections of 0.2 U/kg Humalog® and 0.6 U/kg Lantus® during three separate dosing visits.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Biochaperone Combo	Injection of BioChaperone Combo
DRUG	Humalog Mix25	Injection of Humalog Mix25
DRUG	Humalog	Injection of Humalog
DRUG	Lantus	Injection of Lantus
DRUG	Placebo	Injection of saline 0.9% solution

Timeline

• Start date: 2015-07-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2015-08-04
• Last updated: 2015-12-02

Locations

1 site across 1 country: Germany