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

Adocia

Status and phase

Completed

Phase 2

Phase 1

Conditions

Type 1 Diabetes Mellitus

Treatments

Drug: Insulin Lispro (Humalog®)

Drug: Regular human insulin (Huminsulin® Normal)

Drug: BioChaperone Human Insulin (HinsBet®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02739906

BC3-CT021

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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