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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT01438632
Eligibility Criteria:
Inclusion Criteria:
* Body-mass index 18-32 kg/m2
* Stable glycaemic control with HbA1c 6.0-9.0%
* Duration of diabetes \>1 year
* Insulin use at least once daily or with subcutaneous pump
* Blood pressure \<160/90 mmHg
Exclusion Criteria:
* Inability to provide informed consent
* Requirement of \<8 units of rapid-acting insulin (analogue) before meals
* Chronic use of sulphonylurea derivatives, GLP-1 based treatments, acarbose or thiazolidinediones
* Treatment with prednisolone, non-steroidal anti-inflammatory drugs (NSAIDs), immunosuppressive agents, cytostatic drugs, hormone therapy except insulin, thyroid supplementation and oral anticonceptives
* Known allergy to aspart insulin
* 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 past 6 months
* Pregnancy or the intention to become pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01438632
Study Brief:
Protocol Section:
NCT01438632