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 @ 7:56 PM
Ignite Modification Date:
2025-12-24 @ 7:56 PM
NCT ID:
NCT01183104
Eligibility Criteria:
Inclusion Criteria:
1. Patients with type 2 diabetes who are oral hypoglycemic agent naive or, α-glucosidase inhibitor or biguanide monotherapy (to be washed out 4 weeks prior to randomization)
2. Signed informed consent obtained before any trial-related activities
3. Treatment with diet and exercise for 12 weeks and longer at screening
4. Age =\>60 y.o.
5. Male and Female
6. HbA1c 6.9%=\< \<8.9%
Exclusion Criteria:
1. Active proliferative retinopathy or maculopathy requiring treatment
2. Liver dysfunction (\>x2 of upper normal limit), moderate or severe renal dysfunction(serum Cr\>1.5mg/dL in male, Cr\>1.3mg/dL in female, eGFR\<30), severe cardiac disease (NYHA III or IV), malignancy or uncontrolled hypertension (treated or untreated) as judged by the Investigator
3. Mental incapacity (including moderate or severe dementia) precluding adequate understanding and/or cooperation as judged by the Investigator
4. Recurrent hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
5. Previous history of severe allergy to pharmaceutical products
6. Systemic glucocorticoids users or potential users
7. Suspected type 1 diabetes (including slowly progressive insulin dependent diabetes mellitus) or positive anti-glutamic acid decarboxylase antibody
8. Any condition that the investigator considers a potential obstacle to trial participation and/or data analysis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT01183104
Study Brief:
Protocol Section:
NCT01183104