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

NCT01981031 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2017-06-01

No results posted yet for this study

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

Interventions

DRUG

BioChaperone® Combo

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

DRUG

Humalog® Mix25

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

Sponsors & Collaborators

  • Adocia

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2013-12-31
Completion
2014-08-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01981031 on ClinicalTrials.gov