type 2 diabetes
Conditions
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria will be included: 1) HbA1c level equal or more than 7.0 % and less than 9.0 % 2) Fasting glucose level equal or more than 130 mg/dL and less than 210 mg/dL 3) Patients who are capable of giving informed consent 4) Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after completion of the study
Exclusion criteria
Exclusion criteria: 1) Patients with type 1 diabetes mellitus; patients with diabetes mellitus due to other specified drugs, mechanisms, or diseases; and patients with gestational diabetes mellitus 2) Patients with a medical history of diabetic coma 3) Patients with heart failure 4) Patients with a complication of active chronic hepatitis or hepatic cirrhosis 5) Patients undergoing treatment of glomerular diseases other than diabetic nephropathy 6) Patients with a history or complication of malignant tumor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics 1) Plasma saxagliptin concentration 2) Plasma BMS-510849 concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamics 1) Plasma DPP4 activity 2) Blood glucose level 3) Blood C-peptide concentration 4) Blood insulin concentration 5) Blood glucagon concentration 6) Plasma active GLP-1 concentration | — |
Outcome results
None listed