Clinical trial NCT03176524: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Adocia
Sponsor class: INDUSTRY
First posted: 2017-06-05
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Clinical safety laboratory
timeFrame: Up to 10 weeks
measure: Physical examination
timeFrame: Up to 10 weeks
measure: ECG parameters
timeFrame: Up to 10 weeks
measure: Vital signs
timeFrame: Up to 10 weeks
measure: Adverse events and serious adverse events
timeFrame: Up to 10 weeks
measure: Assessments of local tolerability at injection site
timeFrame: Up to 10 weeks
Secondary outcomes:
measure: AUCPK 0-30min
timeFrame: From 0 to 30 min
measure: AUC PK 0-4h
timeFrame: From 0 to 4 hours
measure: ΔAUCPG 0-30min
timeFrame: From 0 to 30 min
measure: ΔAUCPG 0-4h
timeFrame: From 0 to 4 hours
measure: ΔPG 30min
timeFrame: From 0 to 30 min
measure: Percentage of patients achieving a plasma glucose increase of ≥20 mg/dL from baseline within 30 minutes after treatment
timeFrame: 30 min after drug administration
measure: Time to plasma glucose increase of ≥20 mg/dL from baseline
timeFrame: Up to 4 hours after drug administration
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung GmbH
Study officials:
affiliation: Profil Institut für Stoffwechselforschung GmbH
name: Ulrike Hövelmann, MD
role: PRINCIPAL_INVESTIGATOR
References: