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Trial record 1 of 1 for:    BioChaperone glucagon
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A Trial to Investigate the Safety and the Pharmacokinetic, Pharmacodynamic Characteristics of Two BioChaperone® Glucagon Formulations Compared to Marketed GlucaGen® in Subjects With T1DM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03176524
Recruitment Status : Completed
First Posted : June 5, 2017
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: BioChaperone® glucagon formulation 1 Drug: BioChaperone® glucagon formulation 2 Drug: GlucaGen® HypoKit® Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 6, 2017
Actual Primary Completion Date : September 4, 2017
Actual Study Completion Date : September 4, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Glucagon

Arm Intervention/treatment
Experimental: BioChaperone® glucagon formulation 1
Single subcutaneous fixed doses (50 µg and 1.0 mg)
Drug: BioChaperone® glucagon formulation 1
Injection of BioChaperone® glucagon formulation 1 at Day 1: 50 µg and at Day 2: 1 mg

Experimental: BioChaperone® glucagon formulation 2
Single subcutaneous fixed doses (50 µg and 1.0 mg)
Drug: BioChaperone® glucagon formulation 2
Injection of BioChaperone® glucagon formulation 2 at Day 1: 50 µg and at Day 2: 1 mg

Active Comparator: GlucaGen® HypoKit®
Single subcutaneous fixed doses (50 µg and 1.0 mg)
Drug: GlucaGen® HypoKit®
Injection of GlucaGen® HypoKit® at Day 1: 50 µg and at Day 2: 1 mg




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176524


Locations
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Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, 41460
Sponsors and Collaborators
Adocia
Investigators
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Principal Investigator: Ulrike Hövelmann, MD Profil Institut für Stoffwechselforschung GmbH
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Responsible Party: Adocia
ClinicalTrials.gov Identifier: NCT03176524    
Other Study ID Numbers: BC13-CT028
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glucagon
Glucagon-Like Peptide 1
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins