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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

Primary Purpose

Type 1 Diabetes Mellitus

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

BioChaperone Human Insulin (HinsBet®)

Insulin Lispro (Humalog®)

Regular human insulin (Huminsulin® Normal)

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Profil Mainz GmbH & Co.KG
Profil GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

HinsBet®

Humalog®

Huminsulin® Normal

Arm Description

Outcomes

Primary Outcome Measures

BG1h

Blood glucose (BG) concentration 1 hour after start of intake of a standardised meal

Secondary Outcome Measures

ΔBG1h

Mean change from baseline of blood glucose concentration 1 hour after start of intake of a standardised meal

AUCBG,0-1h

Area under the blood glucose concentration-time curve from 0-1 hour after a standardised meal

ΔAUCBG,0-1h

Incremental area under the blood glucose concentration-time curve from 0-1 hour after a standardised meal

AUCIns,0-1h

Area under the serum insulin concentration-time curve from 0-1 hour

Adverse Events

Number of Adverse Events

Local tolerability (Number of injection site reactions)

Number of injection site reactions

Full Information

NCT ID

NCT02739906

First Posted

April 12, 2016

Last Updated

August 17, 2016

Sponsor

Adocia

1. Study Identification

Unique Protocol Identification Number

NCT02739906

Brief Title

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

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

April 2016 (undefined)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Adocia

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HinsBet®

Arm Type

Experimental

Arm Title

Humalog®

Arm Type

Active Comparator

Arm Title

Huminsulin® Normal

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

BioChaperone Human Insulin (HinsBet®)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Insulin Lispro (Humalog®)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Regular human insulin (Huminsulin® Normal)

Intervention Description

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

Primary Outcome Measure Information:

Title

BG1h

Description

Blood glucose (BG) concentration 1 hour after start of intake of a standardised meal

Time Frame

1 hour

Secondary Outcome Measure Information:

Title

ΔBG1h

Description

Mean change from baseline of blood glucose concentration 1 hour after start of intake of a standardised meal

Time Frame

1 hour

Title

AUCBG,0-1h

Description

Area under the blood glucose concentration-time curve from 0-1 hour after a standardised meal

Time Frame

1 hour

Title

ΔAUCBG,0-1h

Description

Incremental area under the blood glucose concentration-time curve from 0-1 hour after a standardised meal

Time Frame

1 hour

Title

AUCIns,0-1h

Description

Area under the serum insulin concentration-time curve from 0-1 hour

Time Frame

1 hour

Title

Adverse Events

Description

Number of Adverse Events

Time Frame

Up to 11 weeks

Title

Local tolerability (Number of injection site reactions)

Description

Number of injection site reactions

Time Frame

Up to 11 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Oliver Klein, MD

Organizational Affiliation

Profil GmbH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Profil Mainz GmbH & Co.KG

City

Mainz

ZIP/Postal Code

44116

Country

Germany

Facility Name

Profil GmbH

City

Neuss

ZIP/Postal Code

41460

Country

Germany

12. IPD Sharing Statement

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