Clareo Health | Comparison of Explorative Formulation of Insulin Degludec and Insulin Aspart Co-formulation Versus Explorative Formulation of Insulin Degludec and Insulin Aspart Separately Compared With Biphasic Insulin Aspart 30 in Male Subjects With Diabetes
Comparison of Explorative Formulation of Insulin Degludec and Insulin Aspart Co-formulation Versus Explorative Formulation of Insulin Degludec and Insulin Aspart Separately Compared With Biphasic Insulin Aspart 30 in Male Subjects With Diabetes
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novo Nordisk A/S
Age
18–69
Sex
MALE
Healthy volunteers
Accepted
You may be eligible if
The subject will be a male volunteer, who is considered to be generally healthy, except for underlying diabetes mellitus and concomitant medical complications (e.g. hypertension) based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
Glycosylated haemoglobin A1c (HbA1c) below or equal to 10 % based on central laboratory results
ADDITIONAL INCLUSION CRITERA FOR SUBJECTS WITH TYPE 1 DIABETES:
Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months
Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2 (both inclusive)
ADDITIONAL INCLUSION CRITERA FOR SUBJECTS WITH TYPE 2 DIABETES:
Diagnosed with type 2 diabetes mellitus for at least 12 months
Treated with insulin for the last 3 months prior to screening.
Body Mass Index (BMI) between 22.0 and 35.0 kg/m\^2 (both inclusive)
You may not be if
A subject with a history of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trial product, as judged by the Investigator
A subject who has participated in any other trials involving investigational products within the 3 months preceding the start of dosing
