Diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
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 with negative serological tests. 5, Subject judged as adequate for this study by study physician at screening.
Exclusion criteria
Exclusion criteria: 1, Subjects with present and/or past illness considered inadequate for this study. 2, Subjects with past history of drug allergy. 3, Subjects with history of caffeine, alcohol and/or drug abuse. 4, Subjects who was judged not appropriate for this study by study physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of hyperglycemic glucose clamp technique. Evaluation of the parameters of the first- and second- insulin secretory ability, and the transitions of glucose, insulin and c-peptide | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety by evaluating AEs, serum potassium, and VAS for pain. | — |
Countries
Japan
Contacts
SOUSEIKAI Hakata Clinic Planning & Coordination Dept