A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog®

Type 1 Diabetes Mellitus Clinical Trial

Official title:

A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02562313
• Other study ID #: BC3-CT015
• Status: Completed
• Phase: Phase 1
• First received: September 28, 2015
• Last updated: November 21, 2016
• Start date: September 2015
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: Adocia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This study is constituted of 2 parts:

Part A: A total of 36 patients will be enrolled in part A. Each eligible subject will participate in two 14-day treatment periods with Continuous Subcutaneous Insulin Infusion (CSII) of BioChaperone insulin lispro and insulin lispro (Humalog®, Eli Lilly and Company). Each treatment period consists of 10 treatment days under free living conditions (e.g. home / workplace) and under standardised conditions at the clinic. Various assessments for pharmacodynamics, pharmacokinetics, pump compatibility, short-term efficacy and safety are performed on selected days, including:

• Mixed Meal Test (MMT), Day 1, Day 3, Day 12 and Day 14, that will assess the post-prandial glucose response for 6 hours after individualized standard meal (fixed nutrient ratio) ingestion and bolus administration via CSII.

• Continuous Glucose Monitoring (CGM), (Day 1 - 14) that will be used in blinded mode (i.e. neither subjects nor the investigators are aware of the sensor glucose values).

• Pump compatibility (Day 1 - 14): Subjects will continue CSII treatment with the Investigational Medicinal Products (IMP) during the outpatient periods.

Part B: A total of 44 patients will be enrolled. Subjects will be randomized to a 4-period cross-over study aiming at comparing the performance of BC Lispro and Humalog after a prandial bolus administration with two different CSII systems (Roche Accu-Chek® Spirit and Medtronic Paradigm® Veo™) or with a syringe. Pharmacodynamics, pharmacokinetics, pump compatibility and safety will be analyzed.

Each period will include a mixed meal tolerance test with a CSII device and a mixed meal tolerance test with the same dose of insulin administered with a syringe.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Type 1 diabetes for at least 12 months

• Body Mass Index (BMI) between 18.5 and 28.5 kg/m^2, both inclusive

• Using or having used a Roche CSII system (Accu-Chek® Spirit Combo/ Accu- Chek® Spirit) for at least 6 months before screening. In Part B subjects using any form of CSII treatment for at least 6 months before screening will be included.

• HbA1c <= 9.0%.

• Total insulin dose of < 1.2 (I)U/kg/day

• Ability to calculate insulin bolus manually or using a bolus calculator and willingness to consume regular meals, perform carbohydrate counting, self-monitoring of plasma glucose (SMPG) profiles and use of Continuous Glucose Monitoring (CGM).

• Fasting C-peptide <= 0.30 nmol/L

Exclusion Criteria:

• Known or suspected hypersensitivity to Investigational Medicinal Product(s) (IMP(s)) or related products

• Type 2 diabetes mellitus

• Previous participation in this trial.

• Receipt of any investigational product in a clinical trial within 60 days before randomisation in this trial

• Clinically significant abnormal haematology, biochemistry, urinalysis, or coagulation screening test

• Presence of clinically significant acute gastrointestinal symptoms

• Known slowing of gastric emptying and or gastrointestinal surgery

• Unusual meal habits and special dietary requirements or unwillingness to eat the food provided in the trial

• History of diabetic ketoacidosis (DKA) episodes requiring hospitalization within 6 months prior to screening

• History of abscess at the infusion site within 6 months prior to screening

• Hypoglycaemia unawareness as judged by the Investigator

• History of severe hypoglycaemic episodes requiring hospitalization within the last 6 months prior to screening

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• BioChaperone insulin lispro
BioChaperone insulin lispro bolus infusion followed by test meal intake
• Humalog®
Humalog® bolus infusion followed by test meal intake

Locations

Country	Name	City	State
Germany	Profil GmbH	Neuss

Sponsors (2)

Lead Sponsor	Collaborator
Adocia	Eli Lilly and Company

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacodynamics: ?AUCBG 0-2h	Incremental Area Under the Blood Glucose concentration-time Curve from 0-2 hours after the start of the meal.	2 Hours	No
Primary	Pharmacokinetics: AUClis 0-30min	Area Under the serum insulin Lispro concentration-time Curve from 0-30 minutes	30 minutes	No
Secondary	AUClis_0-6h	Area Under the baseline adjusted insulin Lispro Curve from 0-6h following a bolus dose	up to 6 Hours	No
Secondary	Cmax	Maximum insulin Concentration following a bolus dose	up to 6 Hours	No
Secondary	tCmax	Time to Maximum insulin Concentration following a bolus dose	up to 6 Hours	No
Secondary	BGmax	Maximum Blood Glucose after start of an individualised standardised meal intake	up to 6 Hours	No
Secondary	tBGmax	Time to Maximum Blood Glucose concentration	up to 6 Hours	No
Secondary	Compatibility	Number of suspected episodes of infusion set occlusion or leakage	up to 14 days	No
Secondary	Adverse Events	Number of Adverse Events	up to 12 weeks	Yes
Secondary	Local tolerability	Number of injection site reactions	up to 12 weeks	Yes