Type 2 diabetes
Conditions
Interventions
investigational material(s)
Generic name etc : Onglyza tablet
INN of investigational material : saxagliptin
Therapeutic category code : 396 Antidiabetic agents
Dosage and Administration for Investigat
Sponsors
Kyowa Hakko Kirin Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects with a diagnosis of type 2 diabetes mellitus. 2) Subjects who have been undergoing dietary and exercise therapy and have not taken any oral antihyperglycemic medications for more than 12 weeks prior to initiation of study treatment.
Exclusion criteria
Exclusion criteria: 1) Subjects with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety and efficacy | — |
Outcome results
None listed