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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01162876

Enrollment

Registered

2010-07-15

Start date

2010-07-31

Completion date

2010-11-30

Last updated

2017-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

Diabetes, Type 2

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.

Interventions

DRUGsaxaglipitin

oral administration of 5 mg tablet before breakfast for 14 consecutive days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics	daily, up to 42days	Concentrations of plasma saxagliptin and BMS-510849
Pharmacodynamics	daily, up to 42 days	Plasma DPP4 actyivity Concentrations of blood glucose, C-peptide, insulin and glucagon Plasma active GLP-1 concentration

Secondary

Measure	Time frame	Description
Safety issues	daily, up to 42 days	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)

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026