Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-24 @ 1:41 PM
NCT ID:
NCT04236895
Eligibility Criteria:
Inclusion Criteria:
* Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedures that would not have been performed during normal management of the subject).
* Male subjects with type 1 diabetes mellitus for at least 12 months prior to screening as diagnosed clinically.
* Age between 18 and 64 years, both inclusive.
* Body Mass Index (BMI) between 18.5 and 29.0 kg/m\^2, both inclusive.
* HbA1c \<= 9.0%.
* Fasting negative C-peptide (\<= 0.30 nmol/L).
* Total insulin dose of \< 1.2 (I)U/kg/day.
* Stable insulin regimen for at least 2 months prior to screening (with respect to safety of the subject and scientific integrity of the trial).
* Considered generally healthy (apart from type 1 diabetes mellitus) upon completion of medical history, physical examination, vital signs, ECG and analysis of laboratory safety variables, as judged by the Investigator
Exclusion Criteria:
* Known or suspected hypersensitivity to IMPs or related products
* Previous participation in this trial. Participation is defined as randomized
* Receipt of any medicinal product in clinical development within 30 days or 5 half-lives (whichever is longer) before randomization in this trial
* History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
* Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the Investigator
* Any history or presence of clinically relevant comorbidity (with the exception of conditions associated with diabetes mellitus), or signs of acute illness, as judged by the Investigator
* Proliferative retinopathy or maculopathy (based on a recent (\<1.5 years) ophthalmologic examination) and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator
* Recurrent severe hypoglycemia (more than 1 severe hypoglycemic event during the past 6 months) or hypoglycemic unawareness as judged by the Investigator
* Increased risk of thrombosis, e.g. subjects with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the Investigator
* Significant history of alcoholism or drug abuse as judged by the Investigator or consuming more than 24 grams alcohol/day
* Symptomatic hypotension or supine blood pressure at screening (after resting for at least 5 min in supine position) outside the range of 90-140 mmHg for systolic or greater than 90 mmHg for diastolic pressure
* Heart rate at rest outside the range of 50-90 beats per minute
* Clinically significant abnormal standard 12-lead ECG after 5 minutes resting in supine position at screening, as judged by the Investigator
* A positive result in the alcohol and/or urine drug screen at the screening visit
* Not able or willing to refrain from smoking and use of nicotine substitute products one day before and during the inpatient period
* Positive to the screening test for Hepatitis Bs antigen or Hepatitis C antibodies and/or a positive result to the test for HIV-1/2 antibodies or HIV-1 antigen
* Any medication (prescription and non-prescription drugs) within 14 days before IMP administration, with the exception of occasional use of Paracetamol or NSAIDs
* Blood donation or blood loss of more than 500 mL within the last 3 months
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Fertile male with female partner(s) without using a highly effective contraceptive method in combination with spermicide-coated condoms from the first dosing until 1 month after dosing
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT04236895
Study Brief:
Protocol Section:
NCT04236895