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A Trial to Investigate the Safety and the Pharmacokinetic, Pharmacodynamic Characteristics of Two BioChaperone® Glucagon Formulations Compared to Marketed GlucaGen® in Subjects With T1DM

NCT ID: NCT03176524

Last Updated: 2017-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-06

Study Completion Date

2017-09-04

Brief Summary

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This is a single centre, double-blind, randomised, three-period crossover phase 1 trial in subjects with type 1 diabetes mellitus (T1DM). Each subject will be randomly allocated to a sequence of three treatments, i.e. two single subcutaneous doses of BioChaperone® Glucagon (BC Glucagon) formulation 1, BioChaperone® Glucagon formulation 2 and GlucaGen® HypoKit®, each at the fixed doses of 50 µg and 1 mg on 3 separate dosing visits.

Following trial drug administration, pharmacokinetics (PK) and pharmacodynamics (PD) assessments will be carried until 4 hours. Safety will be assessed during all the trial period.

The total trial maximum duration for the individual subject will be up to 10 weeks.

Detailed Description

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Conditions

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Type 1 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BioChaperone® glucagon formulation 1

Single subcutaneous fixed doses (50 µg and 1.0 mg)

Group Type EXPERIMENTAL

BioChaperone® glucagon formulation 1

Intervention Type DRUG

Injection of BioChaperone® glucagon formulation 1 at Day 1: 50 µg and at Day 2: 1 mg

BioChaperone® glucagon formulation 2

Single subcutaneous fixed doses (50 µg and 1.0 mg)

Group Type EXPERIMENTAL

BioChaperone® glucagon formulation 2

Intervention Type DRUG

Injection of BioChaperone® glucagon formulation 2 at Day 1: 50 µg and at Day 2: 1 mg

GlucaGen® HypoKit®

Single subcutaneous fixed doses (50 µg and 1.0 mg)

Group Type ACTIVE_COMPARATOR

GlucaGen® HypoKit®

Intervention Type DRUG

Injection of GlucaGen® HypoKit® at Day 1: 50 µg and at Day 2: 1 mg

Interventions

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BioChaperone® glucagon formulation 1

Injection of BioChaperone® glucagon formulation 1 at Day 1: 50 µg and at Day 2: 1 mg

Intervention Type DRUG

BioChaperone® glucagon formulation 2

Injection of BioChaperone® glucagon formulation 2 at Day 1: 50 µg and at Day 2: 1 mg

Intervention Type DRUG

GlucaGen® HypoKit®

Injection of GlucaGen® HypoKit® at Day 1: 50 µg and at Day 2: 1 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female patients aged between 18 and 64 years (both inclusive)
* Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months prior to the screening visit
* Treated with daily insulin for T1DM ≥ 12 months prior to the screening visit
* Stable insulin treatment at least 3 months prior to the screening visit
* Stable disease with HbA1c \<9.0 %
* C peptide \<=0.30 nmol/L
* Body mass index (BMI) \< 30.0 kg/m2

Exclusion Criteria

* Type 2 Diabetes mellitus
* Previous participation in this trial. Participation is defined as being randomised
* Receipt of any medicinal product in clinical development within 60 days prior to this trial
* Clinically significant abnormal haematology, biochemistry, urinalysis, or coagulation screening tests, as judged by the Investigator considering the underlying disease
* Known or suspected hypersensitivity to the trial products or related products
* Severe hypoglycaemic events within one month prior to screening, as judged by the investigator
* Recent administration of glucagon (within 3 months prior to Screening)
* Clinically relevant diabetic complications as judged by the investigator
* Women of child bearing potential not willing to use contraceptive methods
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adocia

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ulrike Hövelmann, MD

Role: PRINCIPAL_INVESTIGATOR

Profil Institut für Stoffwechselforschung GmbH

Locations

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Profil Institut für Stoffwechselforschung GmbH

Neuss, , Germany

Site Status

Countries

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Germany

Other Identifiers

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BC13-CT028

Identifier Type: -

Identifier Source: org_study_id