Blood Glucose Control With BioChaperone Insulin Lispro Compared to Insulin Lispro (Humalog®) After Ingestion of a Standardized Meal

NCT ID: NCT02344992

Last Updated: 2017-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-06-30

Brief Summary

The addition of BioChaperone to already marketed prandial insulin analogue accelerates the onset and shorten the duration of action of insulin lispro due to facilitation of the absorption of the insulin after subcutaneous injection.

This trial is intented to compare the post-prandial blood glucose control of BioChaperone insulin lispro and Humalog® when injected after a standardized meal as well as the pharmacokinetic profile of BioChaperone insulin lispro and Humalog® in subjects with type 1 diabetes mellitus.

This is a double-blinded, randomized, controlled, two-period crossover phase Ib trial to compare the blood glucose control after ingestion of a standardized meal, with BioChaperone Lispro at 0.2U/Kg and Humalog at 0.2U/Kg.

Conditions

Diabetes Mellitus Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Biochaperone Insulin Lispro

Group Type: EXPERIMENTAL

BioChaperone insulin lispro

Intervention Type: DRUG

Single dose of 0.2 U/kg body weight injected subcutaneously

Humalog®

Group Type: ACTIVE_COMPARATOR

Humalog®

Intervention Type: DRUG

Single dose of 0.2 U/kg body weight injected subcutaneously

Interventions

BioChaperone insulin lispro

Single dose of 0.2 U/kg body weight injected subcutaneously

Intervention Type: DRUG

Humalog®

Single dose of 0.2 U/kg body weight injected subcutaneously

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Type 1 Diabetes Mellitus ≥ 12 months
• Treated with multiple daily insulin injections or CSII ≥ 12 months
• BMI 18.5-28.0 kg/m² (both inclusive)
• HbA1C%≤9%

Exclusion Criteria

• Type 2 Diabetes Mellitus
• Receipt of any trial product within 60 days prior to this trial
• Clinically significant abnormal haematology, biochemistry, lipids or urinalysis screening tests as judged by the investigator considering the underlying disease
• Presence of clinically significant acute gastroinstestinal symptoms as judged by the investigator
• Known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption.
• Any systemic treatment with drugs known to interfere with glucose metabolism
• Use of any tobacco or nicotine-contained product within one year prior to screening

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adocia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grit Andersen, MD

Role: PRINCIPAL_INVESTIGATOR

Profil GmbH

Locations

Profil GmbH

Neuss, , Germany

Countries

Germany

Other Identifiers

2014-005028-92

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BC3-CT011

Identifier Type: -

Identifier Source: org_study_id