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 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT01947556
Eligibility Criteria:
Inclusion Criteria:
* diabetes mellitus type 1 or 2
* Age 18-75 years
* Body-Mass Index ≥25 kg/m2 and ≤40 kg/m2
* Stable glycaemic control with HbA1c ≥48 (6.5%) and ≤86 mmol/mol (10%)
* Insulin treatment according to basal-bolus regimen, i.e. by multiple daily injections at least four times daily, or by subcutaneous insulin pump, for at least 12 months, use of metformin allowed
Exclusion Criteria:
* Inability to provide informed consent
* Insulin requirement of \<34 or \>200 units per day
* Treatment with systemic corticosteroids, immunosuppressive or cytostatic drugs
* Known allergy to aspart insulin
* Use of oral antidiabetic drugs other than metformin
* Symptomatic diabetic neuropathy
* History of a major cardiovascular disease event (myocardial infarction, stroke, symptomatic peripheral artery disease, coronary bypass surgery, percutaneous coronary or peripheral artery angioplasty) in the previous 6 months
* Pregnancy or the intention to become pregnant
* Renal disease (creatinine \>150 μmol/l or MDRD-GFR \<30 ml/min/1.73m2)
* Liver disease (aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range)
* Presence of any other medical condition that might interfere with the study protocol
* anemia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01947556
Study Brief:
Protocol Section:
NCT01947556