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 @ 9:13 PM
Ignite Modification Date:
2025-12-24 @ 9:13 PM
NCT ID:
NCT00258804
Eligibility Criteria:
The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.
Main criteria are listed hereafter:
Inclusion Criteria:
* Patients with Type 2 Diabetes mellitus (but without history of ketoacidosis);
* BMI \> 25 and \< 40 kg/m2;
* Willingness to participate and to fast during Ramadan;
* Patients should be either:
* Insulin naïve patients
* Patients already receiving insulin
Exclusion Criteria:
* Pregnancy (as determined by pregnancy blood test at inclusion visit)
* Breast- feeding
* Women of childbearing potential who do not have adequate contraceptive protection
* Need for treatment during the study period with medications that may interfere with the study protocol
* Treatment with any investigational drug (only if in trial) in the last 3 months before entry into the study
* History of drug or alcohol abuse
* Severe and unbalanced diabetic retinopathy
* Clinically relevant cardiovascular, gastrointestinal, hepatic, renal, neurological, endocrine, hematological or other major systemic diseases that may interfere with the study protocol or complicate the interpretation of study results
* Night shift workers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Study:
NCT00258804
Study Brief:
Protocol Section:
NCT00258804