A Trial to Assess the Efficacy and Safety of BioChaperone Combo and Humalog Mix 25 in Subjects With Type 1 Diabetes
NCT ID: NCT01981031
Last Updated: 2017-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
21 participants
INTERVENTIONAL
2013-11-30
2014-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-response and Dose-exposure Relationship of BioChaperone Insulin Lispro in Three Different Doses in Subjects With Type 1 Diabetes
NCT02146651
Postprandial Blood Glucose Control With BioChaperone® Combo and Insulin Lispro (Humalog®) Mix 25 in People With Type 1 Diabetes Mellitus
NCT02514954
A Trial to Investigate the Dose-linearity of BioChaperone® Combo 75/25 and the Safety at Three Different Doses in Subjects With Type 2 Diabetes
NCT03180710
A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog®
NCT02562313
A Trial to Investigate the Safety and the Pharmacokinetic, Pharmacodynamic Characteristics of Two BioChaperone® Glucagon Formulations Compared to Marketed GlucaGen® in Subjects With T1DM
NCT03176524
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A
Drug: BioChaperone® Combo
BioChaperone® Combo
Single dose of 0.8U/kg body weight injected subcutaneously (under the skin)
B
Drug: Humalog® Mix25
Humalog® Mix25
Single dose of 0.8U/kg body weight injected subcutaneously (under the skin)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
64 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Adocia
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Neuss, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BC3-CT005
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.