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

This study has been completed.
Sponsor:
Information provided by:
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01162876
First received: July 12, 2010
Last updated: June 15, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes
 Drug: saxaglipitin
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Clinical Pharmacology Study of Saxagliptin in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

Drug Information available for: Saxagliptin
U.S. FDA Resources

Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: daily, up to 42days ] [ Designated as safety issue: Yes ]
    Concentrations of plasma saxagliptin and BMS-510849

  • Pharmacodynamics [ Time Frame: daily, up to 42 days ] [ Designated as safety issue: Yes ]
    Plasma DPP4 actyivity Concentrations of blood glucose, C-peptide, insulin and glucagon Plasma active GLP-1 concentration


Secondary Outcome Measures:
  • Safety issues [ Time Frame: daily, up to 42 days ] [ Designated as safety issue: Yes ]
    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)


Estimated Enrollment: 20
Study Start Date: July 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: saxagliptin
5 mg daily for 14days
 Drug: saxaglipitin
oral administration of 5 mg tablet before breakfast for 14 consecutive days

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162876

Locations
Japan
Kyushu Clinical Pharmacology Reserch Clinic
Fukuoka, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
  More Information

No publications provided

Responsible Party: Katsuhisa Saito, Senior Operating Officer, Director, Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01162876     History of Changes
Other Study ID Numbers: 262-09-003, JapicCTI-101190
Study First Received: July 12, 2010
Last Updated: June 15, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
Diabetes, Type 2

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Saxagliptin
Dipeptidyl-Peptidase IV Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013