Clinical trial NCT02739906: A Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With T1DM
Official title: A Randomised, Double Blind, Three-period Cross-over Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With Type 1 Diabetes Mellitus (T1DM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Adocia
Sponsor class: INDUSTRY
First posted: 2016-04-15
Enrollment: 36
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: This is a 2 centres, randomised, double blind, three-treatment, three-period cross-over trial in subjects with type 1 diabetes mellitus.

Each subject will be administered individualised single subcutaneous doses of BioChaperone Human Insulin (HinsBet®), insulin lispro (Humalog®) and regular human insulin (Huminsulin® Normal) immediately before ingesting a standardised mixed meal.

Following trial drug administration, PK and PD assessments will be carried until 6 hours after start of the standardized test meal.

The total trial duration for an individual subject will be up to 11 weeks.


Eligibility criteria: Inclusion Criteria:

* Male or female subject aged 18-64 years (both inclusive).
* 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.
* BMI 18.5-28.0 kg/m\^2 (both inclusive).
* HbA1c \<= 9.0 % by local laboratory analysis
* Fasting C-peptide \<= 0.30 nmol/L.

Exclusion Criteria:

* Known or suspected hypersensitivity to IMPs 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, coagulation, 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.
* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using highly effective contraceptive methods

Primary outcomes:
measure: BG1h
timeFrame: 1 hour
Secondary outcomes:
measure: ΔBG1h
timeFrame: 1 hour
measure: AUCBG,0-1h
timeFrame: 1 hour
measure: ΔAUCBG,0-1h
timeFrame: 1 hour
measure: AUCIns,0-1h
timeFrame: 1 hour
measure: Adverse Events
timeFrame: Up to 11 weeks
measure: Local tolerability (Number of injection site reactions)
timeFrame: Up to 11 weeks
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Profil Mainz GmbH & Co.KG
city: Neuss
country: Germany
facility: Profil GmbH
Study officials:
affiliation: Profil GmbH
name: Oliver Klein, MD
role: PRINCIPAL_INVESTIGATOR
References: