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 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT01039532
Eligibility Criteria:
Inclusion Criteria:
* Type 2 Diabetics \>/= 18 yrs of age Diabetic for \>/= 6months
* Inadequately controlled patients treated with human premixed insulin twice daily for at least 3months along with metformin 2g/d and pio30mg/d
* Single dose of insulin exceeding 25 units or total insulin dose is more than 0.7u/kg/day with
* If post lunch blood glucose is not controlled
* If HbA1c ≥7%
* No major cardiac events in the preceding 6 months.
* NYHA \<= Class II.
Exclusion Criteria:
* Deranged LFT's- AST,ALT or ALP values \>= 2 times.
* Deranged RFT Sr. Creatinine \>=1.5
* Allergy to Insulin or its products.
* Recent intake of any new medications for sugar control.
* Illiterate to the level that she/he cannot understand the study.
* Any other acute co morbid illness.
* Pregnancy.
* Decompensated heart failure/UsA/MI all within last 12month
* Untreated proliferative retinopathy/ maculopathy
* Drug or alcohol dependence
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01039532
Study Brief:
Protocol Section:
NCT01039532