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 @ 5:00 AM
Ignite Modification Date:
2025-12-25 @ 5:00 AM
NCT ID:
NCT02224118
Eligibility Criteria:
Inclusion Criteria:
Part 1
* Weighs greater than or equal to (\>=) 50 kilogram (kg) and less than (\<) 100 kg and has a body mass index (BMI) of \>= 18.5 and \<25.0 at the time of screening tests
* Is a non-smoker, or is able to refrain from smoking from 2 days before screening tests until completion of post-treatment examinations or follow-up investigations
* Is able to refrain from consuming alcohol from 2 days before screening tests until completion of screening tests, from 2 days before hospitalization (Day -4) until after discharge (Day 8), from 2 days before clinic visits (Days 13 and 20) until completion of tests at clinic visits (Days 15 and 22), and from 2 days before post-treatment examinations or follow-up investigations until completion of post-treatment examinations or follow-up investigations
* Has agreed to use a medically acceptable form of contraception (example \[eg\], condoms) from the day of hospitalization (Day -2) until completion of post-treatment examinations or follow-up investigations
* Has no clinically problematic abnormalities in medical examinations and tests before study treatment
Part 2
* Weighs \>= 50 kg and \<100 kg and has a BMI of \>=18.5 and \<37.0 at the time of screening tests
* Was diagnosed with type 2 diabetes mellitus at least 3 months before screening tests and this is being stably managed with dietary modification, exercise therapy, or sulfonylureas or biguanides If sulfonylureas or biguanides are being used, these have been used at a fixed dosage to stably manage the disease since at least 3 months before screening tests
* If the participant has hyperlipidemia, this has been stably managed with antihyperlipidemic drugs at a fixed dosage since at least 3 months before screening tests
* If the participant has hypertension, this has been stably managed with antihypertensive drugs at a fixed dosage since at least 3 months before screening tests
* Is a non-smoker, or is able to refrain from smoking during the hospitalization period and from 1 day before clinic visit days until completion of tests
Exclusion Criteria:
Part 1
* Has or has had hepatic, renal, central nervous system (including psychiatric), cardiovascular, respiratory, gastrointestinal, hematopoietic, ophthalmic, infectious, or endocrine disease that would make the participant unsuitable as a study participant
* Has had a malignant tumor within 5 years before study treatment
* Has undergone surgery that would make the participant unsuitable as a study participant within 12 weeks before screening tests
* Has or had acute disease that occurred within 7 days before study treatment
* Has or has had an eating disorder (pathological anorexia or bulimia)
Part 2
* If only dietary modification and exercise therapy are being used, fasting blood glucose is \<130 milligram per deciliters (mg/dL) or \>= 270 mg/dL in screening tests and at hospitalization (Day -1). If oral antihyperglycemic drugs are being used, fasting blood glucose is \<100 mg/dL or \>= 240 mg/dL at the time of screening tests and \<120 mg/dL or \>= 270 mg/dL at hospitalization (Day -1)
* If only dietary modification and exercise therapy are being used, HbA 1C at the time of Screening tests is \<6% or \>= 10 percent (%). If oral antihyperglycemic drugs are being used, HbA 1C at the time of screening tests is \<6% or \>=9%
* Has blood pressure or a pulse rate that is outside of the following ranges, or has hypertension and blood pressure or a pulse rate that is outside of the following ranges despite taking an antihypertensive drug at the same dosage since at least 3 months before screening tests
* Has or has had type 1 diabetes mellitus
* Has or has had autoimmune diabetes mellitus
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
64 Years
Study:
NCT02224118
Study Brief:
Protocol Section:
NCT02224118