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 @ 3:42 PM
Ignite Modification Date:
2025-12-24 @ 3:42 PM
NCT ID:
NCT01865292
Eligibility Criteria:
Inclusion Criteria:
* Glycosylated haemoglobin (HbA1c) below or equal to 10 procent based on central laboratory results
* Specific inclusion criteria for subject with type 1 diabetes:
* Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months prior to screening
* Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2 (both inclusive)
* Specific inclusion criteria for subject with type 2 diabetes:
* Diagnosed with type 2 diabetes mellitus for at least 12 months prior to screening
* Treated with insulin for the past 3 months prior to screening
* Body Mass Index (BMI) between 22.0 and 35.0 kg/ m\^2 (both inclusive)
Exclusion Criteria:
* Subject with a history of significant multiple drug allergies or with a known allergy or suspected allergy to the trial product or any medicine chemically related to the trial product,as judged by the Investigator.
* Subject with a history of or presence of cancer
* Any condition that the Investigator and/or Sponsor feels would interfere with study
* Specific exclusion criteria for subject with type 2 diabetes:
* Therapy with oral antidiabetic drugs within the past 3 months prior to screening
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
69 Years
Study:
NCT01865292
Study Brief:
Protocol Section:
NCT01865292