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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Drug: Biochaperone® Combo; Drug: Humalog® Mix25

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany, 41460
    • Profil Institut für Stoffwechselforschung GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delta AUCBG,0-2h	Incremental area under the blood glucose concentration-time curve from 0-2 hours after a standardised meal	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delta AUCBG,0-6h	Incremental area under the blood glucose concentration-time curve from 0-6 hours after a standardised meal	6 hours
BGmax	Maximum blood glucose concentration after a standardised meal (0-6 hours)	6 hours
tBGmax	Time to maximum blood glucose concentration after a standardised meal (0-6 hours)	6 hours
AUCLisp,0-6h,	Area under the plasma insulin lispro concentration-time curve from 0-6 hours	6 hours
AUCGlarg,0-6h	Area under the plasma insulin glargine concentration-time curve from 0-6 hours	6 hours
Cmax,Lisp	Maximum observed plasma insulin lispro concentration	6 hours
Cmax,Glarg	Maximum observed plasma insulin glargine concentration	6 hours
Adverse events	Number of adverse events	Up to 7 weeks
Local tolerability	Number and intensity of injection site reactions	Up to 7 weeks

Collaborators and Investigators

• Sponsor: Adocia
• Investigators: Principal Investigator: Ulrike Hövelmann, MD, Profil Institut Für Stoffwechselfforschung GmbH

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: July 29, 2015
• First Submitted That Met QC Criteria: July 31, 2015
• First Posted (Estimate): August 4, 2015

Study Record Updates

• Last Update Posted (Estimate): November 6, 2015
• Last Update Submitted That Met QC Criteria: November 5, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Lispro
• Other Study ID Numbers: BC3-CT019