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

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03176524
• Other study ID #: BC13-CT028
• Status: Completed
• Phase: Phase 1
• First received: June 1, 2017
• Last updated: December 11, 2017
• Start date: June 6, 2017
• Est. completion date: September 4, 2017

Study information

• Verified date: December 2017
• Source: Adocia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 4, 2017
• Est. primary completion date: September 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• BioChaperone® glucagon formulation 1
Injection of BioChaperone® glucagon formulation 1 at Day 1: 50 µg and at Day 2: 1 mg
• BioChaperone® glucagon formulation 2
Injection of BioChaperone® glucagon formulation 2 at Day 1: 50 µg and at Day 2: 1 mg
• GlucaGen® HypoKit®
Injection of GlucaGen® HypoKit® at Day 1: 50 µg and at Day 2: 1 mg

Locations

Country	Name	City	State
Germany	Profil Institut für Stoffwechselforschung GmbH	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Adocia

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Up to 10 weeks
Primary	Physical examination	Examination of the body systems	Up to 10 weeks
Primary	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)	Up to 10 weeks
Primary	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)	Up to 10 weeks
Primary	Adverse events and serious adverse events	Untoward medical occurrence	Up to 10 weeks
Primary	Assessments of local tolerability at injection site	Local reaction at injection site	Up to 10 weeks
Secondary	AUCPK 0-30min	area under the baseline adjusted plasma glucagon concentration curve from 0 to 30 min	From 0 to 30 min
Secondary	AUC PK 0-4h	area under the baseline adjusted plasma glucagon concentration curve from 0 to 4 h	From 0 to 4 hours
Secondary	?AUCPG 0-30min	area under the baseline adjusted plasma glucose curve from 0 until 30 min	From 0 to 30 min
Secondary	?AUCPG 0-4h	area under the baseline adjusted plasma glucose curve from 0 until 4h	From 0 to 4 hours
Secondary	?PG 30min	baseline adjusted plasma glucose concentration at 30 min	From 0 to 30 min
Secondary	Percentage of patients achieving a plasma glucose increase of =20 mg/dL from baseline within 30 minutes after treatment	only at day 2	30 min after drug administration
Secondary	Time to plasma glucose increase of =20 mg/dL from baseline	only at day 2	Up to 4 hours after drug administration