A clinical pharmacology study of saxagliptin in patients with type 2 diabetes mellitus

Phase 3

• Conditions: type 2 diabetes

• Registration Number: JPRN-jRCT2080221155
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified