Clinical trial NCT02514954: Postprandial Blood Glucose Control With BioChaperone® Combo and Insulin Lispro (Humalog®) Mix 25 in People With Type 1 Diabetes Mellitus
Official title: Postprandial Blood Glucose Control With BioChaperone® Combo and Insulin Lispro (Humalog®) Mix 25 in People With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Adocia
Sponsor class: INDUSTRY
First posted: 2015-08-04
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Delta AUCBG,0-2h
timeFrame: 2 hours
Secondary outcomes:
measure: Delta AUCBG,0-6h
timeFrame: 6 hours
measure: BGmax
timeFrame: 6 hours
measure: tBGmax
timeFrame: 6 hours
measure: AUCLisp,0-6h,
timeFrame: 6 hours
measure: AUCGlarg,0-6h
timeFrame: 6 hours
measure: Cmax,Lisp
timeFrame: 6 hours
measure: Cmax,Glarg
timeFrame: 6 hours
measure: Adverse events
timeFrame: Up to 7 weeks
measure: Local tolerability
timeFrame: Up to 7 weeks
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung GmbH
Study officials:
affiliation: Profil Institut Für Stoffwechselfforschung GmbH
name: Ulrike Hövelmann, MD
role: PRINCIPAL_INVESTIGATOR
References: