Skip to main content
OpenTrials
Completed

NCT Number: NCT02344992

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil GmbH

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BioChaperone insulin lispro

Drug

Single dose of 0.2 U/kg body weight injected subcutaneously

Humalog®

Drug

Single dose of 0.2 U/kg body weight injected subcutaneously

Primary outcomes

  1. Area under the blood glucose time curve: AUCbg(0-2h)

    Time frame: 2 hours

    Area under the blood glucose concentration time curve from 0-2 hours after a standardised meal

Secondary outcomes

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

    Time frame: 8 hours

  2. Pharmacodynamic: maximum blood glucose concentration after a standardized meal: BGmax

    Time frame: 8 hours

  3. Pharmacokinetic: Area under the serum insulin lispro concentration time curve from 0-8hours: AUClisp(0-8h)

    Time frame: 8 hours

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

    Time frame: 8 hours

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

    Time frame: Up to 7 weeks

Sponsors and collaborators

Lead sponsor

Adocia

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 26, 2015
Registry last updated
Jun 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.