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

NCT01981031 | Completed Phase 1

• 1 other identifier: BC3-CT005
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (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 Outcomes (2)

• Compare pharmacodynamics and pharmacokinetics profiles between BioChaperone® Combo and Humalog® Mix25

  from 0 to 30 hours after a single-dose administration

• Number of Adverse Events

  Weeks 0-10

Study Arms (2)

A

EXPERIMENTAL

Drug: BioChaperone® Combo

Drug: BioChaperone® Combo

B

ACTIVE COMPARATOR

Drug: Humalog® Mix25

Drug: Humalog® Mix25

Interventions

BioChaperone® Combo DRUG

Single dose of 0.8U/kg body weight injected subcutaneously (under the skin)

A

Humalog® Mix25 DRUG

Single dose of 0.8U/kg body weight injected subcutaneously (under the skin)

B

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Adocia: lead

Study Sites (1)

Unknown Facility

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: November 11, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: August 1, 2014
• Last Updated: June 1, 2017

Record last verified: 2014-09

Locations

DE (1)