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A Trial to Investigate the Dose-linearity of BioChaperone® Combo 75/25 and the Safety at Three Different Doses in Subjects With Type 2 Diabetes

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

BioChaperone® Combo 75/25 at 0.6 U/kg

BioChaperone® Combo 75/25 at 0.8 U/kg

BioChaperone® Combo 75/25 at 1.0 U/kg

Humalog® Mix25 at 0.8 U/kg

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female subject aged 18-70 years (both inclusive)
Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
HbA1c level between 6.5% and 9.0 % (both inclusive)
Body mass index between 20.0 and 40.0 kg/m2 (both inclusive)
Body weight <= 125.0 kg at the screening visit
Insulin-treated subjects. Total insulin dose of <= 1.2 (I)U/kg/day

Exclusion Criteria:

Type 1 diabetes mellitus
Known or suspected hypersensitivity to IMP(s) or related products
Previous participation in this trial. Participation is defined as randomised.
Receipt of any medicinal product in clinical development within 60 days before randomisation in this trial.
Clinically significant abnormal values for haematology, biochemistry, coagulation, or urinalysis as judged by the Investigator considering the underlying disease.
Supine blood pressure at screening (after resting for at least 5 min in supine position) outside the range of 90-160 mmHg systolically or 50-95 mmHg diastolically (excluding white-coat hypertension; therefore, if a repeated measurement shows values within the range, the subject can be included in the trial); symptoms of arterial hypotension and/or a heart rate at rest outside the range of 50-90 beats per minute. This exclusion criterion also pertains to subjects being on anti-hypertensives.
Women of child bearing potential not willing to use contraceptive methods.

Sites / Locations

Profil Mainz GmbH & Co. KG
Profil Institut für Stoffwechselforschung GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

BioChaperone® Combo 75/25 at 0.6 U/kg

BioChaperone® Combo 75/25 at 0.8 U/kg

BioChaperone® Combo 75/25 at 1.0 U/kg

Humalog® Mix25 at 0.8 U/kg

Arm Description

Single subcutaneous injection of 0.6 U/kg

Single subcutaneous dose of 0.8 U/kg

Single subcutaneous dose of 1.0 U/kg

Single subcutaneous dose of 0.8 U/kg

Outcomes

Primary Outcome Measures

AUC last_total

Area under the plasma insulin concentration-time curve from t=0 to the last measured total insulin plasma concentration above LLOQ. The total insulin concentration is the sum of lispro and basal concentrations.

Cmax_total

Maximum observed plasma insulin total concentration

Secondary Outcome Measures

AUCGIR 0-last (mg/kg)

Area under the glucose infusion rate curve from 0 hours until the end of clamp

GIRmax (mg/kg/min)

Maximum glucose infusion rate

tGIRmax

Time to maximum glucose infusion rate

Adverse Events

Local tolerability: number of injection site reaction

Frequency of injection site reaction in each arm.

Number of hypoglycaemic events in each treatment arm

Full Information

NCT ID

NCT03180710

First Posted

June 6, 2017

Last Updated

January 9, 2018

Sponsor

Adocia

1. Study Identification

Unique Protocol Identification Number

NCT03180710

Brief Title

A Trial to Investigate the Dose-linearity of BioChaperone® Combo 75/25 and the Safety at Three Different Doses in Subjects With Type 2 Diabetes

Official Title

A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-linearity of BioChaperone® Combo 75/25 and the Safety at Three Different Doses in Subjects With Type 2 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

June 6, 2017 (Actual)

Primary Completion Date

August 28, 2017 (Actual)

Study Completion Date

December 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Adocia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a bicentric, double-blinded, randomised, four-period crossover phase 1 trial, using automated 30-hour euglycemic clamp in subjects with type 2 diabetes mellitus.

Detailed Description

This is a bicentric, double-blinded, randomised, four-period crossover phase 1 trial, using automated 30-hour euglycemic clamp in subjects with type 2 diabetes mellitus. Each subject will be randomly allocated to a sequence of four treatments, three single doses of BioChaperone® Combo 75/25 (0.6 U/kg, 0.8 U/kg or 1.0 U/kg) and one single dose of Humalog® Mix25 at 0.8 U/kg on four separate dosing visits. Subjects will come in a fasted state to the clinical trial centre in the morning of each dosing day and stay at the clinical trial centre until the 30-hour clamp procedures have been terminated.

6. Conditions and Keywords

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

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BioChaperone® Combo 75/25 at 0.6 U/kg

Arm Type

Experimental

Arm Description

Single subcutaneous injection of 0.6 U/kg

Arm Title

BioChaperone® Combo 75/25 at 0.8 U/kg

Arm Type

Experimental

Arm Description

Single subcutaneous dose of 0.8 U/kg

Arm Title

BioChaperone® Combo 75/25 at 1.0 U/kg

Arm Type

Experimental

Arm Description

Single subcutaneous dose of 1.0 U/kg

Arm Title

Humalog® Mix25 at 0.8 U/kg

Arm Type

Active Comparator

Arm Description

Single subcutaneous dose of 0.8 U/kg

Intervention Type

Drug

Intervention Name(s)

BioChaperone® Combo 75/25 at 0.6 U/kg

Intervention Description

Injection of BioChaperone® Combo 75/25 at 0.6 U/kg

Intervention Type

Drug

Intervention Name(s)

BioChaperone® Combo 75/25 at 0.8 U/kg

Intervention Description

Injection of BioChaperone® Combo 75/25 at 0.8 U/kg

Intervention Type

Drug

Intervention Name(s)

BioChaperone® Combo 75/25 at 1.0 U/kg

Intervention Description

Injection of BioChaperone® Combo 75/25 at 1.0 U/kg

Intervention Type

Drug

Intervention Name(s)

Humalog® Mix25 at 0.8 U/kg

Intervention Description

Injection of Humalog® Mix25 at 0.8 U/kg

Primary Outcome Measure Information:

Title

AUC last_total

Description

Time Frame

From 0 to 30 hours

Title

Cmax_total

Description

Maximum observed plasma insulin total concentration

Time Frame

From 0 to 30 hours

Secondary Outcome Measure Information:

Title

AUCGIR 0-last (mg/kg)

Description

Area under the glucose infusion rate curve from 0 hours until the end of clamp

Time Frame

From 0 to 30 hours

Title

GIRmax (mg/kg/min)

Description

Maximum glucose infusion rate

Time Frame

From 0 to 30 hours

Title

tGIRmax

Description

Time to maximum glucose infusion rate

Time Frame

From 0 to 30 hours

Title

Adverse Events

Time Frame

Up to 102 days (maximum duration of subject's participation)

Title

Local tolerability: number of injection site reaction

Description

Frequency of injection site reaction in each arm.

Time Frame

Up to 102 days (maximum duration of subject's participation)

Title

Number of hypoglycaemic events in each treatment arm

Time Frame

Up to 102 days (maximum duration of subject's participation)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female subject aged 18-70 years (both inclusive) Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months HbA1c level between 6.5% and 9.0 % (both inclusive) Body mass index between 20.0 and 40.0 kg/m2 (both inclusive) Body weight <= 125.0 kg at the screening visit Insulin-treated subjects. Total insulin dose of <= 1.2 (I)U/kg/day Exclusion Criteria: Type 1 diabetes mellitus Known or suspected hypersensitivity to IMP(s) or related products Previous participation in this trial. Participation is defined as randomised. Receipt of any medicinal product in clinical development within 60 days before randomisation in this trial. Clinically significant abnormal values for haematology, biochemistry, coagulation, or urinalysis as judged by the Investigator considering the underlying disease. Supine blood pressure at screening (after resting for at least 5 min in supine position) outside the range of 90-160 mmHg systolically or 50-95 mmHg diastolically (excluding white-coat hypertension; therefore, if a repeated measurement shows values within the range, the subject can be included in the trial); symptoms of arterial hypotension and/or a heart rate at rest outside the range of 50-90 beats per minute. This exclusion criterion also pertains to subjects being on anti-hypertensives. Women of child bearing potential not willing to use contraceptive methods.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Oliver Klein, MD

Organizational Affiliation

Profil Institut für Stoffwechselforschung GmbH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Profil Mainz GmbH & Co. KG

City

Mainz

Country

Germany

Facility Name

Profil Institut für Stoffwechselforschung GmbH

City

Neuss

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Trial to Investigate the Dose-linearity of BioChaperone® Combo 75/25 and the Safety at Three Different Doses in Subjects With Type 2 Diabetes

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