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:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT00996658
Eligibility Criteria:
Inclusion criteria:
1. Diagnosis of diabetes mellitus prior to informed consent
2. Patients treated with metformin and pioglitazone (therapy should be unchanged for 12 weeks)
3. Glycosylated haemoglobin A1 \>= 7.5% and \<= 10%
4. Age between 18 and less than 80
5. \- Body Mass index less or equal to 45
Exclusion criteria:
1. Uncontrolled hyperglycaemia during run in period
2. Myocardial infarction, stroke or transient ischaemic accident within 3 months prior to informed consent
3. Impaired hepatic function
4. Gastric by pass surgery
5. Treatment with roziglitazone, GLP 1 analogues, DPP-4 inhibitors or insulin within 3 months prior to informed consent
6. Treatment with anti-obesity drugs
7. Current treatment with systemic steroids at the time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
8. Premenopausal women who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control or do not plan to continue using this method during the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT00996658
Study Brief:
Protocol Section:
NCT00996658