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 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT01697657
Eligibility Criteria:
Inclusion Criteria:
* Type 1 diabetes
* Fasting c-peptide below lower limit of normal fasting range
* Duration of type 1 diabetes for at least 12 months
* Current treatment: Basal - bolus regimen for at least 4 months with intermediate or long-acting insulin once, twice or three times daily as basal insulin and 3-4 premeal insulin aspart or lispro injections
* HbA1c maximum 9.0% (using Biorad Variant method)
* Able and willing to perform self-monitoring of blood glucose
* Basal insulin requirement at least 30% of the total daily insulin dose
* BMI (body Mass Index) maximum 35 kg/m\^2
Exclusion Criteria:
* Proliferative retinopathy or maculopathy requiring acute treatment
* Total daily insulin dose above 1.4 IU/kg/day
* Known unawareness of hypoglycaemia
* Impaired hepatic function
* Impaired renal function
* Cardiac problems
* Uncontrolled, treated/untreated hypertension
* Known or suspected allergy to trial product or related products
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT01697657
Study Brief:
Protocol Section:
NCT01697657