I8R-JE-IGBJ
- Conditions
- Diabetes Mellitus
- Registration Number
- JPRN-jRCT2080223805
- Lead Sponsor
- Eli Lilly Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 75
Type 1 diabetes
Age of 18 to 64 years old
Have been on multiple daily injection of insulin or continuous subcutaneous insulin infusion therapy for at least one year
Body mass Index (BMI) of 18.5 to 30.0 kilograms per meter squared (kg/m2)
Hemoglobin A1c (HbA1c) 10% or less
Type 2 diabetes
Age of 20 to 70 years old
Have been on multiple daily injection of insulin or continuous subcutaneous insulin infusion therapy with/ without oral anti hyperglycemic medications for at least 1 year
BMI of 18.5 to 35.0 kg/m2
HbA1c 10% or less
Have significant changes in insulin regimen and/ or unstable blood sugar control within the past 3 month
Have received a total daily dose of insulin >1.2 units per kilogram (U/kg)
Have a history of an episode of severe hypoglycemia in the 1 month prior to screening or have a history of loss of consciousness within the last 2 years induced other than by hypoglycemia
Have known allergies or sensitivity to LY900018, glucagon, related compounds, or any components of the formulation, or history of significant atopy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>The percentage of the patients who achieved treatment success
- Secondary Outcome Measures
Name Time Method safety<br>pharmacokinetics<br>pharmacodynamics<br>SAE,TEAE, Vital sign, PK and PD parameters