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

Diabetes Mellitus Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02344992
• Other study ID #: BC3-CT011
• Secondary ID: 2014-005028-92
• Status: Completed
• Phase: Phase 1
• First received: January 19, 2015
• Last updated: May 31, 2017
• Start date: January 2015
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Adocia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 1
• Diabetes Mellitus, Type 1

Intervention

Drug:
• BioChaperone insulin lispro
Single dose of 0.2 U/kg body weight injected subcutaneously
• Humalog®
Single dose of 0.2 U/kg body weight injected subcutaneously

Locations

Country	Name	City	State
Germany	Profil GmbH	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Adocia

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the blood glucose time curve: AUCbg(0-2h)	Area under the blood glucose concentration time curve from 0-2 hours after a standardised meal	2 hours
Secondary	Pharmacodynamic: Area under the blood glucose concentration time curve from 0-8 hours after a standardized meal: AUCbg(0-8h)		8 hours
Secondary	Pharmacodynamic: maximum blood glucose concentration after a standardized meal: BGmax		8 hours
Secondary	Pharmacokinetic: Area under the serum insulin lispro concentration time curve from 0-8hours: AUClisp(0-8h)		8 hours
Secondary	Pharmacokinetic: Maximum observed serum insulin lispro concentration: Cmax(lisp)		8 hours
Secondary	Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters		Up to 7 weeks