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

NCT ID: NCT02739906

Last Updated: 2016-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2016-08-31

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

HinsBet®

Group Type: EXPERIMENTAL

BioChaperone Human Insulin (HinsBet®)

Intervention Type: DRUG

BioChaperone Human Insulin (HinsBet®) individualised single subcutaneous injection followed by test meal intake

Humalog®

Group Type: ACTIVE_COMPARATOR

Insulin Lispro (Humalog®)

Intervention Type: DRUG

Insulin Lispro (Humalog®) individualised single subcutaneous injection followed by test meal intake

Huminsulin® Normal

Group Type: ACTIVE_COMPARATOR

Regular human insulin (Huminsulin® Normal)

Intervention Type: DRUG

Regular human insulin (Huminsulin® Normal) individualised single subcutaneous injection followed by test meal intake

Interventions

BioChaperone Human Insulin (HinsBet®)

BioChaperone Human Insulin (HinsBet®) individualised single subcutaneous injection followed by test meal intake

Intervention Type: DRUG

Insulin Lispro (Humalog®)

Insulin Lispro (Humalog®) individualised single subcutaneous injection followed by test meal intake

Intervention Type: DRUG

Regular human insulin (Huminsulin® Normal)

Regular human insulin (Huminsulin® Normal) individualised single subcutaneous injection followed by test meal intake

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adocia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oliver Klein, MD

Role: PRINCIPAL_INVESTIGATOR

Profil GmbH

Locations

Profil Mainz GmbH & Co.KG

Mainz, , Germany

Profil GmbH

Neuss, , Germany

Countries

Germany

Other Identifiers

BC3-CT021

Identifier Type: -

Identifier Source: org_study_id