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OpenTrials
Completed

NCT Number: NCT02514954

Postprandial Blood Glucose Control With BioChaperone® Combo and Insulin Lispro (Humalog®) Mix 25 in People With Type 1 Diabetes Mellitus

Each subject will be randomly allocated to a sequence of two treatments applied at two separate dosing visits. At each dosing visit subjects will be injected with individualised doses of either BioChaperone® Combo or Humalog® Mix 25 immediately before ingesting a standardised mixed meal [(t=0 min) start of the meal]. Insulin doses will be identical at both dosing visits of one individual and will be administered subcutaneously in the abdominal region. Subjects will be asked to consume a standardised meal (e.g. pizza) for dinner at home in the evening before each dosing visit. Subjects will attend the clinical site in a fasted state in the morning of each dosing day and stay at the clinical trial centre until 10-hour after dosing (standardised test-meal procedure has been terminated after 6h). The two dosing visits will be separated by a wash-out period of 5-15 days.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institut für Stoffwechselforschung 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 (as diagnosed clinically) >= 12 months.
  • Treated with multiple daily insulin injections or CSII >= 12 months.
  • Current total daily insulin treatment < 1.2 (I)U/kg/day.
  • Current total daily bolus insulin treatment < 0.7 (I)U/kg/day.
  • Usual Insulin bolus dose between 0.8 and 2 (I)U per 10 g CH (both inclusive). Expecting prandial insulin dose range for standardised meal test between 5 and 12 (I)U.
  • BMI 18.5-28.0 kg/m^2 (both inclusive).
  • HbA1c <= 9.0% by local laboratory analysis
  • Fasting C-peptide <= 0.3 nmol/L.

Exclusion criteria

  • Known or suspected hypersensitivity to trial products or related products.
  • Type 2 diabetes mellitus.
  • Previous participation in this trial. Participation is defined as randomised.
  • Participation in any Clinical Trial within 3 months 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 gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), 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.
  • Unusual meal habits and special diet requirements or unwillingness to eat the food provided in the trial.
  • Women of child bearing potential, not willing to use contraceptive methods.

Treatment and study plan

Biochaperone® Combo

Drug

Subcutaneous injection of an individualized dose

Humalog® Mix25

Drug

Subcutaneous injection of an individualized dose

Primary outcomes

  1. Delta AUCBG,0-2h

    Time frame: 2 hours

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

Secondary outcomes

  1. Delta AUCBG,0-6h

    Time frame: 6 hours

    Incremental area under the blood glucose concentration-time curve from 0-6 hours after a standardised meal

  2. BGmax

    Time frame: 6 hours

    Maximum blood glucose concentration after a standardised meal (0-6 hours)

  3. tBGmax

    Time frame: 6 hours

    Time to maximum blood glucose concentration after a standardised meal (0-6 hours)

  4. AUCLisp,0-6h,

    Time frame: 6 hours

    Area under the plasma insulin lispro concentration-time curve from 0-6 hours

  5. AUCGlarg,0-6h

    Time frame: 6 hours

    Area under the plasma insulin glargine concentration-time curve from 0-6 hours

  6. Cmax,Lisp

    Time frame: 6 hours

    Maximum observed plasma insulin lispro concentration

  7. Cmax,Glarg

    Time frame: 6 hours

    Maximum observed plasma insulin glargine concentration

  8. Adverse events

    Time frame: Up to 7 weeks

    Number of adverse events

  9. Local tolerability

    Time frame: Up to 7 weeks

    Number and intensity of injection site reactions

Sponsors and collaborators

Lead sponsor

Adocia

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 4, 2015
Registry last updated
Nov 6, 2015

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.

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