A Trial to Evaluate the Pharmacokinetic and Pharmacodynamic Properties of BioChaperone® Insulin Lispro, Fiasp® and NovoRapid® Delivered by an Insulin Pump

NCT03179332 | Completed Phase 1

• 1 other identifier: CT032-ADO02
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-centre, randomised, double-blind, three-period, complete cross-over trial comparing the pharmacokinetic and the pharmacodynamic properties of BioChaperone® insulin lispro and the two active comparators Fiasp® and Novorapid® when given as a bolus on top of basal delivery with an insulin pump in subjects with type 1 diabetes mellitus. Each subject will be randomly assigned to a treatment sequence consisting of 3 dosing visits during which the subject will receive the investigational products. In a euglycaemic clamp setting, subjects will be given a bolus dose of 0.15 U/kg body weight. Throughout the glucose clamp procedure, blood glucose will be stabilised at a target level of 100 mg/dL by means of an intravenous infusion of glucose. Blood samples for pharmacokinetic assessment will be drawn at specified timepoints and glucose infusion rates and blood glucose concentrations will be recorded for pharmacodynamic assessment during the 10-hour clamp procedure after dosing.

Conditions

Type1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• AUCGIR(0-60min)

  Baseline corrected area under the glucose infusion rate curve from 0 to 60 minutes after bolus administration

  60 minutes

Secondary Outcomes (9)

• AUCins(0-30min)

  30 minutes

• AUCins(0-60min)

  60 minutes

• AUCins(0-600min)

  600 minutes

• Cmax insulin

  10 hours

• Tmax insulin

  10 hours

Study Arms (3)

BioChaperone® insulin lispro

EXPERIMENTAL

Single subcutaneous administration of BioChaperone® insulin lispro

Drug: BioChaperone® insulin lispro

Fiasp®

ACTIVE COMPARATOR

Single subcutaneous administration of Fiasp® (insulin aspart)

Drug: Fiasp®

Novorapid®

ACTIVE COMPARATOR

Single subcutaneous administration of Novorapid® (insulin aspart)

Drug: Novorapid®

Interventions

BioChaperone® insulin lispro DRUG

Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump

BioChaperone® insulin lispro

Fiasp® DRUG

Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump

Fiasp®

Novorapid® DRUG

Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump

Novorapid®

Eligibility Criteria

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

You may qualify if:

• Type 1 Diabetes Mellitus for more than 12 months.
• BMI between 18.5 and 28.5 kg/m².
• HbA1C level \<=9.0%.
• Insulin treated for at least 12 months with total insulin dose \<1.2U/kg/day.

You may not qualify if:

• Type 2 Diabetes Mellitus.
• History of multiple and/or severe allergies to drugs or foods.
• Any history or presence of clinically relevant cardiovascular, pulmonary, respiratory, gastrointestinal, hepatic, renal, metabolic, endocrinological (with the exception of conditions associated with diabetes mellitus), haematological, dermatological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the Investigator.
• More than one episode of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months.
• Proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy.
• Females of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant or are not using highly effective contraceptive methods.

Sponsors & Collaborators

• Adocia: lead

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

MeSH Terms

Interventions

Insulin Aspart

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

• Oliver Klein, MD

  Profil Institut für Stoffwechselforschung GmbH

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: June 7, 2017
• Study Start: June 20, 2017
• Primary Completion: September 27, 2017
• Study Completion: September 27, 2017
• Last Updated: December 12, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)