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 @ 4:59 PM
Ignite Modification Date:
2025-12-24 @ 4:59 PM
NCT ID:
NCT02915250
Eligibility Criteria:
Inclusion Criteria:
* Male or female subject aged 18-70 years (both inclusive)
* Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
* HbA1c level between 7.5% and 9.5% (both inclusive)
* Body mass index between 20.0 and 40.0 kg/m2 (both inclusive)
* Treated with once daily injections with insulin glargine U-100 for ≥ 3 months prior to screening
Exclusion Criteria:
* Type 1 diabetes mellitus
* Known or suspected allergy to the IMPs or related products
* Previous participation in this trial. Participation is defined as randomised.
* Receipt of any medicinal product in clinical development within 60 days prior to this trial.
* Clinically significant abnormal haematology, biochemistry, urinalysis or coagulation 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.
* Current treatment with premixed or intermediate insulin products, or with long acting insulins other than insulin glargine U-100. The use of short or rapid acting prandial insulin products will be allowed provided their use has been stable for ≥ 3 months prior to screening.
* Use of GLP-1 receptor agonists or oral antidiabetic drugs (OADs) other than stable intake of metformin alone or metformin in combination with a DPP-4 inhibitor 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:
70 Years
Study:
NCT02915250
Study Brief:
Protocol Section:
NCT02915250