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 @ 6:34 PM
Ignite Modification Date:
2025-12-24 @ 6:34 PM
NCT ID:
NCT00928057
Eligibility Criteria:
Inclusion Criteria:
* Insulin requiring diabetics (type 1 or type 2)
* Using a pen device for injections at least once per day, for at least two months prior to baseline (Study Visit Two).
* 18 to 75 years of age, inclusive.
* Body Mass Index from 18 to 50 kg/m², inclusive.
* Hemoglobin A1c from 5.5 to 9.5 percent (%), inclusive.
* Largest single dose of insulin a day less than or equal to 40 units
Exclusion Criteria:
* Current status or history of a medical condition that would contraindicate treatment with the study product or other conditions which, in the opinion of the Investigator, would place the subject at risk or have the potential to confound interpretation of the study results (i.e. recent history of ketoacidosis, hypoglycemic unawareness, etc.).
* Hemophilia or any other disorder which causes excessive bleeding or requires frequent transfusions.
* History of intravenous drug abuse (self-reported).
* Bleeding disorder, hemophilia or subject is currently taking anti-coagulant medications (e.g., heparin, Coumadin®, warfarin).
* Self-reported blood borne infection.
* Pregnant (from medical history only).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00928057
Study Brief:
Protocol Section:
NCT00928057