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

Phase 1

Completed

• Conditions: Diabetes Mellitus Type 1
• Interventions: Drug: BioChaperone insulin lispro; Drug: Humalog®

• Registration Number: NCT02344992
• Lead Sponsor: Adocia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-19
• Study First Submitted QC: 2015-01-19
• Study First Posted: 2015-01-26
• Status Verified: 2015-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2017-05-31
• Last Update Posted: 2017-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Biochaperone Insulin Lispro	BioChaperone insulin lispro	-
Humalog®	Humalog®	-

Primary Outcome Measures

Name	Time	Method
Area under the blood glucose time curve: AUCbg(0-2h)	2 hours	Area under the blood glucose concentration time curve from 0-2 hours after a standardised meal

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamic: maximum blood glucose concentration after a standardized meal: BGmax	8 hours
Pharmacokinetic: Area under the serum insulin lispro concentration time curve from 0-8hours: AUClisp(0-8h)	8 hours
Pharmacodynamic: Area under the blood glucose concentration time curve from 0-8 hours after a standardized meal: AUCbg(0-8h)	8 hours
Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters	Up to 7 weeks
Pharmacokinetic: Maximum observed serum insulin lispro concentration: Cmax(lisp)	8 hours

Trial Locations

Locations (1)

Profil GmbH; 🇩🇪 Neuss, Germany