Type 1 Diabetes Mellitus
Conditions
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.
Interventions
DRUGBioChaperone® glucagon formulation 1
Injection of BioChaperone® glucagon formulation 1 at Day 1: 50 µg and at Day 2: 1 mg
DRUGBioChaperone® glucagon formulation 2
Injection of BioChaperone® glucagon formulation 2 at Day 1: 50 µg and at Day 2: 1 mg
DRUGGlucaGen® HypoKit®
Injection of GlucaGen® HypoKit® at Day 1: 50 µg and at Day 2: 1 mg
Sponsors
Adocia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| Assessments of local tolerability at injection site | Up to 10 weeks | Local reaction at injection site |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUCPK 0-30min | From 0 to 30 min | area under the baseline adjusted plasma glucagon concentration curve from 0 to 30 min |
| Time to plasma glucose increase of ≥20 mg/dL from baseline | Up to 4 hours after drug administration | only at day 2 |
| AUC PK 0-4h | From 0 to 4 hours | area under the baseline adjusted plasma glucagon concentration curve from 0 to 4 h |
| ΔAUCPG 0-30min | From 0 to 30 min | area under the baseline adjusted plasma glucose curve from 0 until 30 min |
| 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 |
Countries
Germany
Outcome results
None listed