NCT02915250

A Trial to Compare Post Prandial Blood Glucose Control of BioChaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes

A Randomised, Double-blind, Double-dummy, Three-period Cross-over Trial to Compare Post Prandial Blood Glucose Control 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: 36 (actual)
• Sponsor: Adocia · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a two-centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over study using a standardised solid meal test in subjects with type 2 diabetes to investigate postprandial glucose control of BioChaperone® Combo compared with Humalog® Mix25 and with simultaneous subcutaneous injections of Humalog® and Lantus® during three separate dosing visits.

Detailed description

This is a two-centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over study using a standardised solid meal test in subjects with type 2 diabetes to investigate postprandial glucose control of BioChaperone® Combo compared with Humalog® Mix25 and with simultaneous subcutaneous injections of Humalog® and Lantus® during three separate dosing visits. Furthermore, this study aims to compare the pharmacokinetic (PK) profiles of the three different study treatments. During each dosing visit, subjects will be given 3 doses of IMP on three consecutive days (Day 1, Day 2 and Day 3). Dosing on Day 2 and Day 3 will be followed by a standardised solid meal test.

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 0.9% NaCl

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2016-09-26
• Last updated: 2017-06-29

Locations

2 sites across 1 country: Germany