Diabetes Mellitus, Type 1
Conditions
Interventions
investigational material(s)
Generic name etc : LY2963016
INN of investigational material : Insulin glargin
Therapeutic category code : 396 Antidiabetic agents
Dosage and Administration for Investigati
Sponsors
Eli Lilly Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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
Exclusion criteria
Exclusion criteria: -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
Outcome results
None listed