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Postprandial Blood Glucose Control With BioChaperone® Combo and Insulin Lispro (Humalog®) Mix 25 in People With Type 1 Diabetes Mellitus

Primary Purpose

Type 1 Diabetes Mellitus

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Biochaperone® Combo

Humalog® Mix25

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:

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.

Sites / Locations

Profil Institut für Stoffwechselforschung GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BioChaperone® Combo

Humalog® Mix25

Arm Description

1 single dose 400 U/mL

1 single dose 100 U/mL

Outcomes

Primary Outcome Measures

Delta AUCBG,0-2h

Incremental area under the blood glucose concentration-time curve from 0-2 hours after a standardised meal

Secondary Outcome Measures

Delta AUCBG,0-6h

Incremental area under the blood glucose concentration-time curve from 0-6 hours after a standardised meal

BGmax

Maximum blood glucose concentration after a standardised meal (0-6 hours)

tBGmax

Time to maximum blood glucose concentration after a standardised meal (0-6 hours)

AUCLisp,0-6h,

Area under the plasma insulin lispro concentration-time curve from 0-6 hours

AUCGlarg,0-6h

Area under the plasma insulin glargine concentration-time curve from 0-6 hours

Cmax,Lisp

Maximum observed plasma insulin lispro concentration

Cmax,Glarg

Maximum observed plasma insulin glargine concentration

Adverse events

Number of adverse events

Local tolerability

Number and intensity of injection site reactions

Full Information

NCT ID

NCT02514954

First Posted

July 29, 2015

Last Updated

November 5, 2015

Sponsor

Adocia

1. Study Identification

Unique Protocol Identification Number

NCT02514954

Brief Title

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

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

July 2015 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 2015 (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

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.

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

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BioChaperone® Combo

Arm Type

Experimental

Arm Description

1 single dose 400 U/mL

Arm Title

Humalog® Mix25

Arm Type

Active Comparator

Arm Description

1 single dose 100 U/mL

Intervention Type

Drug

Intervention Name(s)

Biochaperone® Combo

Intervention Description

Subcutaneous injection of an individualized dose

Intervention Type

Drug

Intervention Name(s)

Humalog® Mix25

Intervention Description

Subcutaneous injection of an individualized dose

Primary Outcome Measure Information:

Title

Delta AUCBG,0-2h

Description

Incremental area under the blood glucose concentration-time curve from 0-2 hours after a standardised meal

Time Frame

2 hours

Secondary Outcome Measure Information:

Title

Delta AUCBG,0-6h

Description

Incremental area under the blood glucose concentration-time curve from 0-6 hours after a standardised meal

Time Frame

6 hours

Title

BGmax

Description

Maximum blood glucose concentration after a standardised meal (0-6 hours)

Time Frame

6 hours

Title

tBGmax

Description

Time to maximum blood glucose concentration after a standardised meal (0-6 hours)

Time Frame

6 hours

Title

AUCLisp,0-6h,

Description

Area under the plasma insulin lispro concentration-time curve from 0-6 hours

Time Frame

6 hours

Title

AUCGlarg,0-6h

Description

Area under the plasma insulin glargine concentration-time curve from 0-6 hours

Time Frame

6 hours

Title

Cmax,Lisp

Description

Maximum observed plasma insulin lispro concentration

Time Frame

6 hours

Title

Cmax,Glarg

Description

Maximum observed plasma insulin glargine concentration

Time Frame

6 hours

Title

Adverse events

Description

Number of adverse events

Time Frame

Up to 7 weeks

Title

Local tolerability

Description

Number and intensity of injection site reactions

Time Frame

Up to 7 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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ulrike Hövelmann, MD

Organizational Affiliation

Profil Institut Für Stoffwechselfforschung GmbH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Profil Institut für Stoffwechselforschung GmbH

City

Neuss

ZIP/Postal Code

41460

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Postprandial Blood Glucose Control With BioChaperone® Combo and Insulin Lispro (Humalog®) Mix 25 in People With Type 1 Diabetes Mellitus

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