Diabetes Mellitus
Conditions
Interventions
Subcutaneous administration of insulin glargine, 0.2IU/kg.
Subcutaneous administration of insulin glargine, 0.4IU/kg.
Sponsors
Medical Co. LTA, Clinical Pharmacology Center
JCL bioassay corporation
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1, Healthy Japanese male subjects who provide signed written informed consent. 2, Subjects between 20 and 40 (inclusive) year of age at the time of consent. 3, Subjects with BMI <=18.5 and >25.0 at the time of screening. 4, Subjects judged as adequate for this study by study physician.
Exclusion criteria
Exclusion criteria: 1, Subjects with present illness which requires treatment. 2, Subjects with past medical history which was considered not adequate for this study. 3, Subjects with past history of drug allergy. 4, Subjects who took prescribed medicine and/or OTC drug 1 week prior to admission to the clinic. 5. Subjects who donated and/or withdrawn whole blood more than 400mL within 12 weeks, 200mL within 4 weeks, and/or blood component within 2 weeks prior to admission. 6, Subjects who were participated in a clinical trial and administered new compound study drug within 4 weeks, or any kind of study drug within 3 weeks prior to admission. 7, Subjects with history of alcohol and/or drug abuse. 8, Subjects who was judged not appropriate for this study by study physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum insulin glargine concentration | — |
Countries
Japan
Outcome results
None listed