NCT02562326

A Trial to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 2 Diabetes Mellitus

A Randomised, Monocentric, Double-blind, Multiple Daily Dose, Two-period 14 Day Cross-over Trial to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of Individualised Doses of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Adocia · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blind, randomised, controlled, two-period crossover phase Ib trial using an individualised standard meal with a fixed nutrient ratio in subjects with type 2 diabetes mellitus to investigate post-prandial blood glucose control with BioChaperone insulin lispro compared to insulin lispro (Humalog®, Eli Lilly and Company) before and after a period of multiple daily dose administrations for 14 days. Each subject will be randomised to a sequence of two treatments, either BioChaperone insulin lispro-Humalog® or Humalog®-BioChaperone insulin lispro. Injections will take place immediately before an individualised standard meal in the morning of day 1, 2, 13, and 14. Insulin doses will be determined at the screening visit. During the outpatient phase the subjects will keep their basal insulin constant (except changes for safety reason). They will self-measure blood glucose at least 4 times daily (pre-prandial and at bedtime). In addition, on two days per outpatient period (Day 5 and 9) blood glucose will be measured 7 times daily (pre-prandial, 2 hours post-prandial and at bedtime).

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	BioChaperone insulin lispro	Injection immediately before the start of the individualised standard meal
DRUG	Humalog®	Injection immediately before the start of the individualised standard meal

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2015-09-29
• Last updated: 2016-04-29

Locations

2 sites across 1 country: Germany