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

Phase 1

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Drug: Humalog® Mix25; Drug: Biochaperone® Combo

• Registration Number: NCT02514954
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-29
• Study First Submitted QC: 2015-07-31
• Study First Posted: 2015-08-04
• Status Verified: 2015-11
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2015-11-05
• Last Update Posted: 2015-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Humalog® Mix25	Humalog® Mix25	1 single dose 100 U/mL
BioChaperone® Combo	Biochaperone® Combo	1 single dose 400 U/mL

Primary Outcome Measures

Name	Time	Method
Delta AUCBG,0-2h	2 hours	Incremental area under the blood glucose concentration-time curve from 0-2 hours after a standardised meal

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Profil Institut für Stoffwechselforschung GmbH; 🇩🇪 Neuss, Germany