Postprandial Blood Glucose Control With BioChaperone® Combo and Insulin Lispro (Humalog®) Mix 25 in People With Type 1 Diabetes Mellitus
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Adocia
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Delta AUCBG,0-2h
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
BioChaperone® Combo
1 single dose 400 U/mL
Intervention: Biochaperone® Combo (Drug)
Humalog® Mix25
1 single dose 100 U/mL
Intervention: Humalog® Mix25 (Drug)
Outcomes
Primary Outcomes
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
- Cmax,Glarg(6 hours)
- BGmax(6 hours)
- Delta AUCBG,0-6h(6 hours)
- AUCLisp,0-6h,(6 hours)
- Adverse events(Up to 7 weeks)
- Cmax,Lisp(6 hours)
- Local tolerability(Up to 7 weeks)
- tBGmax(6 hours)
- AUCGlarg,0-6h(6 hours)