A Trial to Assess the Efficacy and Safety of BioChaperone Combo and Humalog Mix 25 in Subjects With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

Phase 1 Study to Assess the Efficacy and Safety of BioChaperone® Combo and Humalog® Mix 25 in Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01981031
• Other study ID #: BC3-CT005
• Status: Completed
• Phase: Phase 1
• First received: October 31, 2013
• Last updated: May 31, 2017
• Start date: November 2013
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Adocia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

BioChaperone Combo is a liquid formulation containing both Insulin Glargine and Insulin Lispro.

The aim of this trial is to assess the efficacy and safety of BioChaperone® Combo in subjects with type 1 diabetes under a dose of 0.8 U/kg.

This trial is a phase 1 single-center, randomized, double-blinded, two-treatment, two-period cross-over, 30-hour euglycaemic glucose clamp trial in subjects with type 1 diabetes mellitus. Each subject will be randomly allocated to one single dose of 0.8 U/kg of BioChaperone® Combo and to one single dose of 0.8 U/kg of Humalog® Mix 25 on two separate dosing visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Type 1 diabetes mellitus for at least (or equal to ) 12 months,

• Treated with multiple daily insulin injections or insulin pump treatment for at least (or equal to) 12 months,

• Body Mass Index (BMI): 18.0-28.0kg/m2 (both inclusive)

Exclusion Criteria:

• Type 2 diabetes mellitus,

• The receipt of any investigational product within 3 month prior to first dosing,

• Clinically significant abnormalities, as judged by the investigator,

• Any systemic treatment with drugs known to interfere with glucose metabolism,

• History of alcoholism or drug/chemical abuse and any tobacco product within 5 years prior to screening

• Blood or plasma donation in the past month or more than 500mL within 3 months prior to screening

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• BioChaperone® Combo
Single dose of 0.8U/kg body weight injected subcutaneously (under the skin)
• Humalog® Mix25
Single dose of 0.8U/kg body weight injected subcutaneously (under the skin)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Adocia

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	End of action of 0.8 U/kg BioChaperone® Combo (time from administration until blood glucose concentration is consistently above 8.3 mmol/L during the glucose clamp procedure)		from 0 to 30 hours after a single-dose administration
Secondary	Compare pharmacodynamics and pharmacokinetics profiles between BioChaperone® Combo and Humalog® Mix25		from 0 to 30 hours after a single-dose administration
Secondary	Number of Adverse Events	hypoglycemic events, local tolerability, adverse reactions	Weeks 0-10