A Study in Adults With Type 1 Diabetes
- Conditions
- Diabetes Mellitus, Type 1
- Registration Number
- JPRN-jRCT2080221613
- Lead Sponsor
- Eli Lilly Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Have Type 1 Diabetes Mellitus based on the disease diagnostic criteria (World Health Organization [WHO] Classification)
-Have duration of diabetes greater than or equal to one year
-Have HbA1c less than or equal to 11.0%
-On basal-bolus insulin therapy for at least 1 year (basal insulin must be once daily (QD) injection of human insulin isophane suspension (NPH), Lantus, or detemir and combined with mealtime injections of human regular insulin, or insulin analog lispro, aspart or glulisine)
-Have a body mass index (BMI) of less than or equal to 35 kg/m^2
-Have had more than one episode of severe low blood sugar (defined as needing someone else to help because you had very low blood sugar) within the 6 months before entering the study
-Have had more than one episode of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months before entering the study
-Have known hypersensitivity or allergy to any of the study insulins (insulin glargine or insulin lispro) or to excipients of the study insulins
-Have significant renal, cardiac, gastrointestinal or liver disease
-Have active cancer or cancer within the past 5 years
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method