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

NCT02562313 | Completed Phase 1

• 1 other identifier: BC3-CT015
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Pharmacodynamics: ΔAUCBG 0-2h

  Incremental Area Under the Blood Glucose concentration-time Curve from 0-2 hours after the start of the meal.

  2 Hours

• Pharmacokinetics: AUClis 0-30min

  Area Under the serum insulin Lispro concentration-time Curve from 0-30 minutes

  30 minutes

Secondary Outcomes (8)

• AUClis_0-6h

  up to 6 Hours

• Cmax

  up to 6 Hours

• tCmax

  up to 6 Hours

• BGmax

  up to 6 Hours

• tBGmax

  up to 6 Hours

Study Arms (2)

BioChaperone insulin lispro

EXPERIMENTAL

Drug: BioChaperone insulin lispro

Humalog®

ACTIVE COMPARATOR

Insulin lispro

Drug: Humalog®

Interventions

BioChaperone insulin lispro DRUG

BioChaperone insulin lispro bolus infusion followed by test meal intake

BioChaperone insulin lispro

Humalog® DRUG

Humalog® bolus infusion followed by test meal intake

Humalog®

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adocia: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Profil GmbH

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Tim Heise, MD

  Profil GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: September 29, 2015
• Study Start: September 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 22, 2016

Record last verified: 2016-11

Locations

DE (1)