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 @ 9:23 PM
Ignite Modification Date:
2025-12-24 @ 9:23 PM
NCT ID:
NCT00888732
Eligibility Criteria:
Inclusion Criteria:
* Informed consent obtained before any trial-related activities.
* Diagnosed type 1 diabetes before the age of 40 and on insulin treatment within one year of diagnosis.
* Insulin treatment of any regime for more than one year at time of inclusion.
* Total insulin demand ≥ 0,4 U/IU/kg/24 hrs
* HbA1c between 7% and 12% (both values included).
* Age ≥ 18 years.
* BMI between 18 and 35 kg /m2 (including both values).
Exclusion Criteria:
* Known or suspected allergy to trial product(s) or related products.
* Recurrent major hypoglycaemic episodes.
* Heart: Unstable Angina Pectoris, AMI \< 12 months or heart insufficiency classified according to NYHA III-IV
* Blood Pressure: Severe uncontrolled hypertension with BP \> 180/110 mmHg, sitting
* Liver: Impaired hepatic function corresponding to serum-ALAT or basic phosphatase \> 2 x upper reference limit of the local laboratory.
* Kidneys: Impaired renal function corresponding to serum-creatinin \> 150 μmol/l according to the local laboratory.
* Any disease judged by the investigator to affect the trial.
* Pregnancy, breast-feeding or the intention of becoming pregnant or fertile women not using adequate contraceptive measures - adequate contraceptive method is sterilisation, hysterectomy or current use of contraceptive pills or intra uterine device.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00888732
Study Brief:
Protocol Section:
NCT00888732