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 @ 4:58 PM
Ignite Modification Date:
2025-12-24 @ 4:58 PM
NCT ID:
NCT02514850
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
* HbA1c levels ≤ 9.0%
* Total insulin dose of \< 1.2 U/kg/day
* Body mass index between 20.0 and 35.0 kg/m2 (both inclusive)
* Body weight ≤ 125.0 kg
* Fasting serum C-peptide ≤ 1 nmol/L
* Treated with a stable insulin regimen for ≥ 3 months prior to screening
Exclusion Criteria:
* Type 1 diabetes mellitus
* Known or suspected allergy to the trial products or related products
* Previous participation in this trial. Participation is defined as randomised
* Participation in any clinical trial within 3 months prior to this trial
* Clinically significant abnormal haematology, biochemistry, lipids, or urinalysis screening tests, as judged by the Investigator considering the underlying disease
* Supine blood pressure at screening outside the range of 90-160 mmHg for systolic or 50-95 mmHg for diastolic and/or resting supine heart rate outside the range 50 -90 beats per minute. This exclusion criterion also pertains to subjects being on antihypertensives
* Use of GLP-1 receptor agonists or oral antidiabetic drugs (OADs) other than stable intake of metformin within 4 weeks prior to screening
* Women of child bearing potential, not willing to use contraceptive methods
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT02514850
Study Brief:
Protocol Section:
NCT02514850