Type 2 diabetes
Conditions
Sponsors
Chugai Pharmaceutical Co., Ltd.
Kowa Company, Ltd.
Sanofi K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Has been diagnosed with type 2 diabetes -normal renal function or mild renal impairment patients -HbA1c (Japanese Diabetes Society [JDS] value) >=6.5% and =18.5 kg/m2 and <45.0 kg/m2 Etc.
Exclusion criteria
Exclusion criteria: Had the following history and/or complications within 24 weeks of tests for screening test -Acute diabetic complications such as diabetic ketoacidosis or hyperglycemic hyperosmolar coma -Acute coronary disease (acute myocardial infarction, unstable angina, etc.) or stroke -Recurrent genitourinary tract infection, defined as two or more episodes of complicated or uncomplicated cystitis or pyelonephritis Etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy(change from baseline in HbA1c(JDS)), Safety Absolute change in HbA1c (JDS value) from baseline to treatment week 24 (LOCF) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy(HbA1c, FPG, Body weight) Absolute change in various parameters from baseline to treatment week 24, and percentage of subjects who reached the target HbA1c levels at treatment week 24 | — |
Outcome results
None listed