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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT00457093
Eligibility Criteria:
Inclusion Criteria:
* Type 2 Diabetes
* Currently on a basal insulin, that is, NPH, glargine or detemir
* Capable of self monitoring glucose \>4/day
* Previously complaint with clinical recommendations
* Subject may be on oral antiglycemic medications but no change in treatment is permitted during study.
Exclusion Criteria:
* Hb A1c \>9.0%
* Urinary ketosis
* Currently or expected alteration in insulin sensitivity such as major surgery, infection, renal failure (creatine \>1.5 mg/dL) glucocorticoid treatment, recent (within 2 weeks) serious hypoglycaemic episode (requires assistance of another)
* Currently participating in another clinical trial
* Known or suspected allergy to insulin glargine or detemir
* Using other insulins, such as, bolus insulin or premixed insulin
* Sight or hearing impaired
* Pregnancy oor nursing of the intention of becoming pregnant or not using adequate contraceptive measures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00457093
Study Brief:
Protocol Section:
NCT00457093