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NCT Number: 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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 2

Drug

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

GlucaGen® HypoKit®

Drug

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

Primary outcomes

  1. Clinical safety laboratory

    Time frame: 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)

  2. Physical examination

    Time frame: Up to 10 weeks

    Examination of the body systems

  3. ECG parameters

    Time frame: 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)

  4. Vital signs

    Time frame: 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)

  5. Adverse events and serious adverse events

    Time frame: Up to 10 weeks

    Untoward medical occurrence

  6. Assessments of local tolerability at injection site

    Time frame: Up to 10 weeks

    Local reaction at injection site

Secondary outcomes

  1. AUCPK 0-30min

    Time frame: From 0 to 30 min

    area under the baseline adjusted plasma glucagon concentration curve from 0 to 30 min

  2. AUC PK 0-4h

    Time frame: From 0 to 4 hours

    area under the baseline adjusted plasma glucagon concentration curve from 0 to 4 h

  3. ΔAUCPG 0-30min

    Time frame: From 0 to 30 min

    area under the baseline adjusted plasma glucose curve from 0 until 30 min

  4. ΔAUCPG 0-4h

    Time frame: From 0 to 4 hours

    area under the baseline adjusted plasma glucose curve from 0 until 4h

  5. ΔPG 30min

    Time frame: From 0 to 30 min

    baseline adjusted plasma glucose concentration at 30 min

  6. Percentage of patients achieving a plasma glucose increase of ≥20 mg/dL from baseline within 30 minutes after treatment

    Time frame: 30 min after drug administration

    only at day 2

  7. Time to plasma glucose increase of ≥20 mg/dL from baseline

    Time frame: Up to 4 hours after drug administration

    only at day 2

Sponsors and collaborators

Lead sponsor

Adocia

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 5, 2017
Registry last updated
Dec 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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