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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Drug: BioChaperone® glucagon formulation 1; Drug: BioChaperone® glucagon formulation 2; Drug: GlucaGen® HypoKit®

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany, 41460
    • Profil Institut für Stoffwechselforschung GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BioChaperone® glucagon formulation 1; Single subcutaneous fixed doses (50 µg and 1.0 mg)	Drug: BioChaperone® glucagon formulation 1; Injection of BioChaperone® glucagon formulation 1 at Day 1: 50 µg and at Day 2: 1 mg
Experimental: BioChaperone® glucagon formulation 2; Single subcutaneous fixed doses (50 µg and 1.0 mg)	Drug: BioChaperone® glucagon formulation 2; Injection of BioChaperone® glucagon formulation 2 at Day 1: 50 µg and at Day 2: 1 mg
Active Comparator: GlucaGen® HypoKit®; Single subcutaneous fixed doses (50 µg and 1.0 mg)	Drug: GlucaGen® HypoKit®; Injection of GlucaGen® HypoKit® at Day 1: 50 µg and at Day 2: 1 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Physical examination	Examination of the body systems	Up to 10 weeks
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
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
Adverse events and serious adverse events	Untoward medical occurrence	Up to 10 weeks
Assessments of local tolerability at injection site	Local reaction at injection site	Up to 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCPK 0-30min	area under the baseline adjusted plasma glucagon concentration curve from 0 to 30 min	From 0 to 30 min
AUC PK 0-4h	area under the baseline adjusted plasma glucagon concentration curve from 0 to 4 h	From 0 to 4 hours
ΔAUCPG 0-30min	area under the baseline adjusted plasma glucose curve from 0 until 30 min	From 0 to 30 min
ΔAUCPG 0-4h	area under the baseline adjusted plasma glucose curve from 0 until 4h	From 0 to 4 hours
ΔPG 30min	baseline adjusted plasma glucose concentration at 30 min	From 0 to 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	30 min after drug administration
Time to plasma glucose increase of ≥20 mg/dL from baseline	only at day 2	Up to 4 hours after drug administration

Collaborators and Investigators

• Sponsor: Adocia

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2017
• Primary Completion (Actual): September 4, 2017
• Study Completion (Actual): September 4, 2017

Study Registration Dates

• First Submitted: June 1, 2017
• First Submitted That Met QC Criteria: June 1, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): December 12, 2017
• Last Update Submitted That Met QC Criteria: December 11, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Physiological Effects of Drugs; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Glucagon; Glucagon-Like Peptide 1
• Other Study ID Numbers: BC13-CT028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No