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

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ClinicalTrials.gov Identifier: NCT01162876
Recruitment Status : Completed
First Posted : July 15, 2010
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd

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.

Condition or disease Intervention/treatment Phase
Diabetes Drug: saxaglipitin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Clinical Pharmacology Study of Saxagliptin in Patients With Type 2 Diabetes Mellitus
Study Start Date : July 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Saxagliptin

Arm Intervention/treatment
Experimental: saxagliptin
5 mg daily for 14days
Drug: saxaglipitin
oral administration of 5 mg tablet before breakfast for 14 consecutive days




Primary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: daily, up to 42days ]
    Concentrations of plasma saxagliptin and BMS-510849

  2. Pharmacodynamics [ Time Frame: daily, up to 42 days ]
    Plasma DPP4 actyivity Concentrations of blood glucose, C-peptide, insulin and glucagon Plasma active GLP-1 concentration


Secondary Outcome Measures :
  1. Safety issues [ Time Frame: 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)



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01162876


Locations
Japan
Kyushu Clinical Pharmacology Reserch Clinic
Fukuoka, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd

Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT01162876     History of Changes
Other Study ID Numbers: 262-09-003
JapicCTI-101190 ( Other Identifier: JAPIC )
First Posted: July 15, 2010    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017

Keywords provided by Kyowa Hakko Kirin Co., Ltd:
Diabetes, Type 2

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