A trial to compare how much Dasiglucagon and GlucaGen® activates the immune system after injection under the skin in patients with Type 1Diabetes
- Conditions
- Type 1 Diabetes mellitusMedDRA version: 20.0Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2017-000062-30-DE
- Lead Sponsor
- Zealand Pharma A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 112
- Male or female patients with T1DM for at least 1 year. Diagnostic criteria as defined by the American Diabetes Association
- Hemoglobin A1c (HbA1c) <10%
- Stable anti-diabetic treatment for at least 1 month (e.g. within 10% insulin dose adjustment)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 112
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
3. History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema)
6. Patients on a closed loop artificial pancreas
8. Active malignancy within the last 5 years
9. Congestive heart failure, New York Heart Association class II-IV
10. Inadequately treated blood pressure as defined as systolic blood pressure =160 mmHg or diastolic blood pressure =90 mmHg at screening
11. Current bleeding disorder, including use of anticoagulant treatment
12. Known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma (i.e. insulin-secreting pancreas tumor)
13. Known or suspected HIV infection
14. Use of a systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs in the previous 28 days before Day 1 of this trial
15. Use of systemic corticosteroids, anti-inflammatory biological agents, kinase inhibitors or other immune modulating agents within the last 3 months prior to screening
16. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 X the upper limit of normal (ULN), bilirubin >1.5 X ULN, estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 according to the Modification of Diet in Renal Disease (MDRD) Study definition. Altered electrolytes values of clinical relevance for cardiac conduction, as judged by the investigator.
17. Clinically significant abnormal ECG at screening as evaluated by Investigator
19. A positive result in the alcohol and/or urine drug screen at the screening visit. Significant history of alcoholism or drug abuse as judged by the investigator or consuming more than 24 g alcohol per day for men, or more than 12 g alcohol per day for women.
23. Use of prescription or non-prescription medications known to cause QT prolongation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to evaluate the immunogenicity of repeated single doses of dasiglucagon and GlucaGen following subcutaneous (s.c.) administration compared with s.c. GlucaGen in T1DM patients.;Secondary Objective: The secondary objective is to evaluate the safety, tolerability and pharmacodynamic response of repeated single doses of dasiglucagon following s.c. administration compared with s.c. GlucaGen in T1DM<br>patients.;Primary end point(s): Overall ADA incidence<br>This will be calculated as a percentage of the combined results of treatment-induced ADA-positive patients and treatment-boosted ADA-positive patients and the total number of evaluable patients, excluding baseline-positive patients without any samples available after drug administration. <br>;Timepoint(s) of evaluation of this end point: Visit 7(Day 104 of the follow-up period; EoT visit)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •Treatment-induced ADA<br>Incidence calculated as a percentage of the total number of evaluable patients that were ADA negative at baseline and ADA positive after drug administration and the total number of evaluable patients, excluding baseline positive patients without any samples available after drug administration. <br>•Treatment-boosted ADA<br>Incidence calculated as percentage of baseline ADA-positive patients with significant increases (=5-fold) in ADA titer after drug administration and the total number of evaluable patients, excluding baseline-positive patients without any samples available after drug administration. <br>;Timepoint(s) of evaluation of this end point: Visit 7 (Day 104 of the follow-up period; EoT visit)