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 @ 5:16 PM
Ignite Modification Date:
2025-12-24 @ 5:16 PM
NCT ID:
NCT00118950
Eligibility Criteria:
Inclusion Criteria:
Type-2 diabetes, defined as:
* Age at onset of diabetes ≥ 40 years
* Fasting serum C-peptide ≥ 300 pmol/l or a non-fasting or glucagon-stimulated serum C-peptide ≥ 600 pmol/l
* No history of ketonuria or ketoacidosis.
* BMI ≤ 27 kg/m2.
* Fasting plasma-glucose ≥ 6.5 mmol/l after at least one month of diet-only treatment.
* HbA1c ≤ 9.5% at ongoing oral anti-hyperglycaemic agents. HbA1c ≥ 6.5% after minimum one month of diet-only treatment.
* Weight-loss of no more than 5.0 kg during the last 6 months prior to enrolment.
Exclusion Criteria:
* Type-1 diabetes
* Insulin-treated type-2 diabetes
* Secondary diabetes, heart-failure
* Serum-creatinine above the upper limit
* Serum-ASAT elevated more than 3 fold above the upper limit
* Factor II-VII-X decreased below 0.7
* Ongoing coexisting illnesses with a life-shortening prognosis
* Mental retardation or reduced intellectual behaviour
* Pregnancy
* History of drug-abuse or HbA1c\>10.5% at two separate visits with at least one month interval during treatment-periods.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT00118950
Study Brief:
Protocol Section:
NCT00118950