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

• Sponsor: Adocia (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01981031
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Diabetes Mellitus, Type 1	Drug: BioChaperone® Combo; Drug: Humalog® Mix25	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Phase 1 Study to Assess the Efficacy and Safety of BioChaperone® Combo and Humalog® Mix 25 in Subjects With Type 1 Diabetes
• Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A Drug: BioChaperone® Combo	Drug: BioChaperone® Combo; Single dose of 0.8U/kg body weight injected subcutaneously (under the skin)
Active Comparator: B Drug: Humalog® Mix25	Drug: Humalog® Mix25; Single dose of 0.8U/kg body weight injected subcutaneously (under the skin)

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Compare pharmacodynamics and pharmacokinetics profiles between BioChaperone® Combo and Humalog® Mix25 [from 0 to 30 hours after a single-dose administration]

2. Number of Adverse Events [Weeks 0-10]

   hypoglycemic events, local tolerability, adverse reactions

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Neuss		Germany	41460

Sponsors and Collaborators

• Adocia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Adocia
• ClinicalTrials.gov Identifier: NCT01981031
• Other Study ID Numbers: BC3-CT005
• First Posted: Nov 11, 2013
• Last Update Posted: Jun 1, 2017
• Last Verified: Sep 1, 2014

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Insulin Lispro

Study Results

No Results Posted as of Jun 1, 2017