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 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 12:07 AM
NCT ID:
NCT01194258
Eligibility Criteria:
Inclusion Criteria:
* Males or females ≥18 years
* Type 2 diabetes mellitus (T2DM) treated with insulin ≥12 months and prandial insulin (at least 2 meals per day) for ≥2 months
* Body mass index (BMI) of 23.0 to 45.0 kilograms per meter squared (kg/m\^2)
* Glycosylated hemoglobin (HbA1C) level 7.0 to 8.5%, inclusive
* Fasting C-peptide \<0.6 nanograms per milliliter (ng/mL)
* Willingness to use insulin glargine twice a day as basal insulin for the duration of the study
* Willingness to avoid use of an insulin infusion pump or unblinded continuous glucose monitoring (CGM) during the study
Exclusion Criteria:
* Known or suspected allergy to any component of any of the study drugs
* Exclusive use of pre-mixed insulins
* Use of pramlintide, exenatide, and/or liraglutide within 30 days of screening
* Use of sulfonylureas within two months of screening
* Use of drugs (such as corticosteroids or antimetabolites) that could interfere with the interpretation of study results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia, during the study or within 30 days of screening
* Recurrent severe hypoglycemia (more than 2 episodes over the last 6 months) or hypoglycemic unawareness, as judged by the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01194258
Study Brief:
Protocol Section:
NCT01194258