A Trial to Investigate the Safety and the Pharmacokinetic, Pharmacodynamic Characteristics of Two BioChaperone® Glucagon Formulations Compared to Marketed GlucaGen® in Subjects With T1DM
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Drug: BioChaperone® glucagon formulation 1Drug: BioChaperone® glucagon formulation 2
- Registration Number
- NCT03176524
- Lead Sponsor
- Adocia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description BioChaperone® glucagon formulation 1 BioChaperone® glucagon formulation 1 Single subcutaneous fixed doses (50 µg and 1.0 mg) GlucaGen® HypoKit® GlucaGen® HypoKit® Single subcutaneous fixed doses (50 µg and 1.0 mg) BioChaperone® glucagon formulation 2 BioChaperone® glucagon formulation 2 Single subcutaneous fixed doses (50 µg and 1.0 mg)
- Primary Outcome Measures
Name Time Method Clinical safety laboratory Up to 10 weeks 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)
Assessments of local tolerability at injection site Up to 10 weeks Local reaction at injection site
Physical examination Up to 10 weeks Examination of the body systems
ECG parameters Up to 10 weeks 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 Up to 10 weeks 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 Up to 10 weeks Untoward medical occurrence
- Secondary Outcome Measures
Name Time Method ΔAUCPG 0-30min From 0 to 30 min area under the baseline adjusted plasma glucose curve from 0 until 30 min
AUCPK 0-30min From 0 to 30 min area under the baseline adjusted plasma glucagon concentration curve from 0 to 30 min
AUC PK 0-4h From 0 to 4 hours area under the baseline adjusted plasma glucagon concentration curve from 0 to 4 h
ΔAUCPG 0-4h From 0 to 4 hours area under the baseline adjusted plasma glucose curve from 0 until 4h
ΔPG 30min From 0 to 30 min 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 30 min after drug administration only at day 2
Time to plasma glucose increase of ≥20 mg/dL from baseline Up to 4 hours after drug administration only at day 2
Trial Locations
- Locations (1)
Profil Institut für Stoffwechselforschung GmbH
🇩🇪Neuss, Germany