search
Back to results

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

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
BioChaperone® glucagon formulation 1
BioChaperone® glucagon formulation 2
GlucaGen® HypoKit®
Sponsored by
Adocia
About
Eligibility
Locations
Arms
Outcomes
Full info

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 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

Sites / Locations

  • Profil Institut für Stoffwechselforschung GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

BioChaperone® glucagon formulation 1

BioChaperone® glucagon formulation 2

GlucaGen® HypoKit®

Arm Description

Single subcutaneous fixed doses (50 µg and 1.0 mg)

Single subcutaneous fixed doses (50 µg and 1.0 mg)

Single subcutaneous fixed doses (50 µg and 1.0 mg)

Outcomes

Primary Outcome Measures

Clinical safety laboratory
Haematology, biochemistry and urinalysis: changes or findings from baseline in clinical safety laboratory parameters during the trial duration (screening visit, treatment visits and follow up visit)
Physical examination
Examination of the body systems
ECG parameters
Heart rate, PQ, QRS, QT, QTcB: changes or findings from baseline in ECG parameters during the trial duration (screening visit, treatment visits and follow up visit)
Vital signs
Diastolic and systolic blood pressure (mmHg), Pulse (beats/min), Body temperature (°C), Respiratory frequency (RF/min): changes or findings from baseline in vital signs during the trial duration (screening visit, treatment visits and follow up visit)
Adverse events and serious adverse events
Untoward medical occurrence
Assessments of local tolerability at injection site
Local reaction at injection site

Secondary Outcome Measures

AUCPK 0-30min
area under the baseline adjusted plasma glucagon concentration curve from 0 to 30 min
AUC PK 0-4h
area under the baseline adjusted plasma glucagon concentration curve from 0 to 4 h
ΔAUCPG 0-30min
area under the baseline adjusted plasma glucose curve from 0 until 30 min
ΔAUCPG 0-4h
area under the baseline adjusted plasma glucose curve from 0 until 4h
ΔPG 30min
baseline adjusted plasma glucose concentration at 30 min
Percentage of patients achieving a plasma glucose increase of ≥20 mg/dL from baseline within 30 minutes after treatment
only at day 2
Time to plasma glucose increase of ≥20 mg/dL from baseline
only at day 2

Full Information

First Posted
June 1, 2017
Last Updated
December 11, 2017
Sponsor
Adocia
search

1. Study Identification

Unique Protocol Identification Number
NCT03176524
Brief Title
A Trial to Investigate the Safety and the Pharmacokinetic, Pharmacodynamic Characteristics of Two BioChaperone® Glucagon Formulations Compared to Marketed GlucaGen® in Subjects With T1DM
Official Title
A Randomised, Double-blind, Three-period Crossover Trial to Investigate the Safety and the Pharmacokinetic, Pharmacodynamic Characteristics of Two BioChaperone® Glucagon Formulations Compared to Marketed GlucaGen® in Subjects With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
June 6, 2017 (Actual)
Primary Completion Date
September 4, 2017 (Actual)
Study Completion Date
September 4, 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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

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 ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BioChaperone® glucagon formulation 1
Arm Type
Experimental
Arm Description
Single subcutaneous fixed doses (50 µg and 1.0 mg)
Arm Title
BioChaperone® glucagon formulation 2
Arm Type
Experimental
Arm Description
Single subcutaneous fixed doses (50 µg and 1.0 mg)
Arm Title
GlucaGen® HypoKit®
Arm Type
Active Comparator
Arm Description
Single subcutaneous fixed doses (50 µg and 1.0 mg)
Intervention Type
Drug
Intervention Name(s)
BioChaperone® glucagon formulation 1
Intervention Description
Injection of BioChaperone® glucagon formulation 1 at Day 1: 50 µg and at Day 2: 1 mg
Intervention Type
Drug
Intervention Name(s)
BioChaperone® glucagon formulation 2
Intervention Description
Injection of BioChaperone® glucagon formulation 2 at Day 1: 50 µg and at Day 2: 1 mg
Intervention Type
Drug
Intervention Name(s)
GlucaGen® HypoKit®
Intervention Description
Injection of GlucaGen® HypoKit® at Day 1: 50 µg and at Day 2: 1 mg
Primary Outcome Measure Information:
Title
Clinical safety laboratory
Description
Haematology, biochemistry and urinalysis: changes or findings from baseline in clinical safety laboratory parameters during the trial duration (screening visit, treatment visits and follow up visit)
Time Frame
Up to 10 weeks
Title
Physical examination
Description
Examination of the body systems
Time Frame
Up to 10 weeks
Title
ECG parameters
Description
Heart rate, PQ, QRS, QT, QTcB: changes or findings from baseline in ECG parameters during the trial duration (screening visit, treatment visits and follow up visit)
Time Frame
Up to 10 weeks
Title
Vital signs
Description
Diastolic and systolic blood pressure (mmHg), Pulse (beats/min), Body temperature (°C), Respiratory frequency (RF/min): changes or findings from baseline in vital signs during the trial duration (screening visit, treatment visits and follow up visit)
Time Frame
Up to 10 weeks
Title
Adverse events and serious adverse events
Description
Untoward medical occurrence
Time Frame
Up to 10 weeks
Title
Assessments of local tolerability at injection site
Description
Local reaction at injection site
Time Frame
Up to 10 weeks
Secondary Outcome Measure Information:
Title
AUCPK 0-30min
Description
area under the baseline adjusted plasma glucagon concentration curve from 0 to 30 min
Time Frame
From 0 to 30 min
Title
AUC PK 0-4h
Description
area under the baseline adjusted plasma glucagon concentration curve from 0 to 4 h
Time Frame
From 0 to 4 hours
Title
ΔAUCPG 0-30min
Description
area under the baseline adjusted plasma glucose curve from 0 until 30 min
Time Frame
From 0 to 30 min
Title
ΔAUCPG 0-4h
Description
area under the baseline adjusted plasma glucose curve from 0 until 4h
Time Frame
From 0 to 4 hours
Title
ΔPG 30min
Description
baseline adjusted plasma glucose concentration at 30 min
Time Frame
From 0 to 30 min
Title
Percentage of patients achieving a plasma glucose increase of ≥20 mg/dL from baseline within 30 minutes after treatment
Description
only at day 2
Time Frame
30 min after drug administration
Title
Time to plasma glucose increase of ≥20 mg/dL from baseline
Description
only at day 2
Time Frame
Up to 4 hours after drug administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrike Hövelmann, MD
Organizational Affiliation
Profil Institut für Stoffwechselforschung 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

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs