NCT02344992

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 1, 2017

Status Verified

June 1, 2015

Enrollment Period

5 months

First QC Date

January 19, 2015

Last Update Submit

May 31, 2017

Conditions

Diabetes Mellitus Type 1

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Pharmacodynamic: Area under the blood glucose concentration time curve from 0-8 hours after a standardized meal: AUCbg(0-8h)

    8 hours

  • 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

  • Pharmacokinetic: Maximum observed serum insulin lispro concentration: Cmax(lisp)

    8 hours

  • Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters

    Up to 7 weeks

Study Arms (2)

Biochaperone Insulin Lispro

EXPERIMENTAL
Drug: BioChaperone insulin lispro

Humalog®

ACTIVE COMPARATOR
Drug: Humalog®

Interventions

BioChaperone insulin lisproDRUG

Single dose of 0.2 U/kg body weight injected subcutaneously

Biochaperone Insulin Lispro
Humalog®DRUG

Single dose of 0.2 U/kg body weight injected subcutaneously

Humalog®

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Profil GmbH

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Grit Andersen, 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

January 19, 2015

First Posted

January 26, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 1, 2017

Record last verified: 2015-06

Locations

DE(1)