Diabetes Mellitus
Conditions
Interventions
investigational material(s)
Generic name etc : LY900018
INN of investigational material : glucagon
Therapeutic category code : 249 Other hormone preparations (including antihormone preparations)
Dosag
Sponsors
Eli Lilly Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy The percentage of the patients who achieved treatment success | — |
Secondary
| Measure | Time frame |
|---|---|
| safety pharmacokinetics pharmacodynamics SAE,TEAE, Vital sign, PK and PD parameters | — |
Countries
Japan
Outcome results
None listed