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 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT01087567
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed T2DM (≤ 6 months since diagnosis)
* Drug naïve (less than 2 weeks of insulin and OHAs)
* A1C ≥ 8%
* Age ≥ 18 years
* Normal to high baseline C-peptide (≥ 0.5 ug/dL)
* FBG \> 180 mg/dL, A1C \> 8%.
Exclusion Criteria:
* Pregnancy
* Clinically evident heart failure
* Nephrotic syndrome
* Allergy to insulin or any of the oral medications in the study
* Presence of anti-GAD antibodies
* Islet cell antibodies
* Anti-insulin antibodies
* Any physical disabilities that would preclude self-administration of injectable insulin.
* Evidence of hypoglycemia during screening phase.
* History of lactic acidosis, allergy to metformin or history of chronic renal disease or a serum creatinine \> 1.5 in men or \> 1.4 in women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01087567
Study Brief:
Protocol Section:
NCT01087567