Clinical trial NCT02344992: Blood Glucose Control With BioChaperone Insulin Lispro Compared to Insulin Lispro (Humalog®) After Ingestion of a Standardized Meal
Official title: Blood Glucose Control With BioChaperone Insulin Lispro Compared to Insulin Lispro (Humalog®) After Ingestion of a Standardized Meal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus Type 1
Lead sponsor: Adocia
Sponsor class: INDUSTRY
First posted: 2015-01-26
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Area under the blood glucose time curve: AUCbg(0-2h)
timeFrame: 2 hours
Secondary outcomes:
measure: Pharmacodynamic: Area under the blood glucose concentration time curve from 0-8 hours after a standardized meal: AUCbg(0-8h)
timeFrame: 8 hours
measure: Pharmacodynamic: maximum blood glucose concentration after a standardized meal: BGmax
timeFrame: 8 hours
measure: Pharmacokinetic: Area under the serum insulin lispro concentration time curve from 0-8hours: AUClisp(0-8h)
timeFrame: 8 hours
measure: Pharmacokinetic: Maximum observed serum insulin lispro concentration: Cmax(lisp)
timeFrame: 8 hours
measure: Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters
timeFrame: Up to 7 weeks
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil GmbH
Study officials:
affiliation: Profil GmbH
name: Grit Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References: