Pharmacokinetics and Glucodynamics of LY900014 Compared to Insulin Lispro (Humalog) Following Single Dose Administration in Japanese Patients With Type 1 Diabetes Mellitus
Phase 1
- Conditions
- Diabetes Mellitus, Type 1
- Registration Number
- JPRN-jRCT2080223803
- Lead Sponsor
- Eli Lilly Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- preinitiation
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Inclusion Criteria:
- Are Japanese male or female participant with a diagnosis of T1DM
- Have a body mass index (BMI) of 18.5 to 30.0 kilograms per square meter (kg/m2)
- Have a glycated hemoglobin <9.0%
Exclusion Criteria
- Are receiving chronic systemic or inhaled glucocorticoid therapy, or have received such therapy before screening
- Have a history of renal impairment, or have a high serum creatinine level
- Have proliferative retinopathy or maculopathy and/or severe neuropathy; in particular, autonomic neuropathy based onophthalmologic examination
- Have had any significant changes in insulin regimen and/or unstable blood glucose control prior to screening
- Require daily insulin treatment >1.5 units per kilogram (U/kg)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method