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

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ClinicalTrials.gov Identifier: NCT02514954
Recruitment Status : Completed
First Posted : August 4, 2015
Last Update Posted : November 6, 2015
Sponsor:
Information provided by (Responsible Party):
Adocia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Biochaperone® Combo Drug: Humalog® Mix25 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Postprandial Blood Glucose Control With BioChaperone® Combo and Insulin Lispro (Humalog®) Mix 25 in People With Type 1 Diabetes Mellitus
Study Start Date : July 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BioChaperone® Combo
1 single dose 400 U/mL
Drug: Biochaperone® Combo
Subcutaneous injection of an individualized dose

Active Comparator: Humalog® Mix25
1 single dose 100 U/mL
Drug: Humalog® Mix25
Subcutaneous injection of an individualized dose




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02514954


Locations
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Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, 41460
Sponsors and Collaborators
Adocia
Investigators
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Principal Investigator: Ulrike Hövelmann, MD Profil Institut Für Stoffwechselfforschung GmbH
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Responsible Party: Adocia
ClinicalTrials.gov Identifier: NCT02514954    
Other Study ID Numbers: BC3-CT019
First Posted: August 4, 2015    Key Record Dates
Last Update Posted: November 6, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs