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 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT00121966
Eligibility Criteria:
Inclusion Criteria:
* Ages between 30 and 70 years
* Fasting C-peptide \>300 pmol/l
* Body mass index (BMI) \> 25 kg/m2
* Diabetes for more than 2 years
* Pharmacological antidiabetic treatment for more than 3 months
* 7.0%\<HbA1c\<12.0% at randomisation
* Patient willing to sign informed consent
* Fertile women: negative pregnancy test and use of oral or intra-uterine contraception or depot gestagen.
Exclusion Criteria:
* S-creatinine \> 120 μmol/l
* History of intolerance to metformin or glitazones
* S-ALAT/S-ASAT \> 2.5 x upper normal limit
* Total cholesterol \> 10 mmol/l
* Total triglyceride \> 8 mmol/l
* Hemoglobin (Hb) \< normal range
* Treatment with glitazone preceding 30 days New York Heart Association (NYHA) functional class III or IV
* Night work
* Present or planned pregnancy
* Poor vision impeding insulin administration
* Unawareness of hypoglycaemia (complete or partly)
* Mental illness or alcohol abuse
* Clinically relevant major organ or systemic illness
* Uncontrolled hypertension \>180/110 mmHg, systolic or diastolic
* Steroid treatment
* Severe lung disease
* A history of malign disease
* An expectation that the patient will not be collaborative or will not be able to understand the character of this trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
70 Years
Study:
NCT00121966
Study Brief:
Protocol Section:
NCT00121966