A Clinical Pharmacology Study of Saxagliptin in Patients With Type 2 Diabetes Mellitus

Kyowa Kirin

Status and phase

Completed

Phase 3

Conditions

Diabetes

Treatments

Drug: saxaglipitin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01162876

262-09-003

JapicCTI-101190 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of saxagliptin administered before breakfast for 14 consecutive days in patients with type 2 diabetes mellitus.

Enrollment

20 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients who meet all of the following criteria will be included:
1. HbA1c level ≥7.0% and < 9.0%
2. Fasting glucose level ≥130mg/dL and <210mg/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

Patients with type 1 diabetes mellitus; patients with diabetes mellitus due to other specified drugs, mechanisms, or diseases; and patients with gestational diabetes mellitus
Patients with a medical history of diabetic coma
Patients with heart failure
Patients with a complication of active chronic hepatitis or hepatic cirrhosis
Patients undergoing treatment of glomerular diseases other than diabetic nephropathy
Patients with a history or complication of malignant tumor