Status:
COMPLETED
A Clinical Pharmacology Study of Saxagliptin in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Diabetes
Eligibility:
All Genders
20-65 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- Patients who meet all of the following criteria will be included:
- HbA1c level ≥7.0% and \< 9.0%
- Fasting glucose level ≥130mg/dL and \<210mg/dL
- Patients who are capable of giving informed consent
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01162876
Start Date
July 1 2010
End Date
November 1 2010
Last Update
March 9 2017
Active Locations (1)
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1
Kyushu Clinical Pharmacology Reserch Clinic
Fukuoka, Japan