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 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT01640834
Eligibility Criteria:
Inclusion Criteria:
* Have had type 1 diabetes mellitus (T1DM) based on the World Health Organization classification for at least 1 year and have a daily insulin dose ≤1.5 international units (IU) per kilogram (kg) of body weight
* Have a glycated hemoglobin A1c (HbA1c) of no greater than 9.0% as measured at screening
* Have a body mass index (BMI) ≥19.0 and ≤35.0 kilograms per meter squared (kg/m\^2)
* Have given written informed consent approved by Lilly
Exclusion Criteria:
* Received any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 3 months prior to screening
* Have had more than 1 episode of severe hypoglycemia within 3 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness
* Are pregnant or intend to become pregnant during the course of the study
* Women who are breastfeeding
* Have a history of stroke, myocardial infarction, heart failure, unstable angina, or a coronary revascularization procedure within 6 months of screening
* Have fasting triglycerides \>500 milligrams per deciliter (mg/dL) (5.65 millimoles per liter \[mmol/L\])
* Have obvious clinical signs, symptoms, or laboratory evidence of liver disease (alanine transaminase \[ALT\] or aspartate transaminase \[AST\] greater than 2 times the upper limit of normal at screening)
* Have a history of renal transplantation or are currently receiving renal dialysis or have a screening creatinine \>2.0 mg/dL (177 micromoles per liter \[μmol/L\])
* Have had any other disease, illness, or condition (including known diabetic autonomic neuropathy, drug or alcohol abuse, or psychiatric disorder) within the 6 months prior to screening that precludes the participant from following and completing the study or could increase their risk for hypoglycemia, according to the investigator's judgment
* Are currently enrolled in, have completed, or have discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01640834
Study Brief:
Protocol Section:
NCT01640834