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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01162876
• Other study ID #: 262-09-003
• Secondary ID: JapicCTI-101190
• Status: Completed
• Phase: Phase 3
• First received: July 12, 2010
• Last updated: March 7, 2017
• Start date: July 2010
• Est. completion date: November 2010

Study information

• Verified date: March 2017
• Source: Kyowa Hakko Kirin Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• saxaglipitin
oral administration of 5 mg tablet before breakfast for 14 consecutive days

Locations

Country	Name	City	State
Japan	Kyushu Clinical Pharmacology Reserch Clinic	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics	Concentrations of plasma saxagliptin and BMS-510849	daily, up to 42days
Primary	Pharmacodynamics	Plasma DPP4 actyivity Concentrations of blood glucose, C-peptide, insulin and glucagon Plasma active GLP-1 concentration	daily, up to 42 days
Secondary	Safety issues	Adverse events, skin symptom findings, blood pressure and pulse rate, body temperature, body weight, hypoglycemic symptoms, 12-lead ECG, clinical laboratory tests, and pregnancy test (in women of childbearing potential only)	daily, up to 42 days