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

NCT03176524 | Completed Phase 1

• 1 other identifier: BC13-CT028
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• AUCPK 0-30min

  From 0 to 30 min

• AUC PK 0-4h

  From 0 to 4 hours

• ΔAUCPG 0-30min

  From 0 to 30 min

• ΔAUCPG 0-4h

  From 0 to 4 hours

• ΔPG 30min

  From 0 to 30 min

Study Arms (3)

BioChaperone® glucagon formulation 1

EXPERIMENTAL

Single subcutaneous fixed doses (50 µg and 1.0 mg)

Drug: BioChaperone® glucagon formulation 1

BioChaperone® glucagon formulation 2

EXPERIMENTAL

Single subcutaneous fixed doses (50 µg and 1.0 mg)

Drug: BioChaperone® glucagon formulation 2

GlucaGen® HypoKit®

ACTIVE COMPARATOR

Single subcutaneous fixed doses (50 µg and 1.0 mg)

Drug: GlucaGen® HypoKit®

Interventions

BioChaperone® glucagon formulation 1 DRUG

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

BioChaperone® glucagon formulation 1

BioChaperone® glucagon formulation 2 DRUG

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

BioChaperone® glucagon formulation 2

GlucaGen® HypoKit® DRUG

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

GlucaGen® HypoKit®

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adocia: lead

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ulrike Hövelmann, MD

  Profil Institut für Stoffwechselforschung GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 5, 2017
• Study Start: June 6, 2017
• Primary Completion: September 4, 2017
• Study Completion: September 4, 2017
• Last Updated: December 12, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)