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

Adocia

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus Type 1

Treatments

Drug: Humalog®

Drug: BioChaperone insulin lispro

Study type

Interventional

Funder types

Industry

Identifiers

NCT02344992

2014-005028-92 (EudraCT Number)

BC3-CT011

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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