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

This study has been completed.
Sponsor:
Information provided by:
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01162876
First received: July 12, 2010
Last updated: January 6, 2014
Last verified: January 2014

July 12, 2010
January 6, 2014
July 2010
November 2010   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01162876 on ClinicalTrials.gov Archive Site
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)
Same as current
Not Provided
Not Provided
 
A Clinical Pharmacology Study of Saxagliptin in Patients With Type 2 Diabetes Mellitus
A Clinical Pharmacology Study of Saxagliptin in Patients With Type 2 Diabetes Mellitus

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Diabetes
Drug: saxaglipitin
oral administration of 5 mg tablet before breakfast for 14 consecutive days
Experimental: saxagliptin
5 mg daily for 14days
Intervention: Drug: saxaglipitin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01162876
262-09-003, JapicCTI-101190
No
Katsuhisa Saito, Senior Operating Officer, Director, Otsuka Pharmaceutical Co., Ltd.
Kyowa Hakko Kirin Company, Limited
Not Provided
Not Provided
Kyowa Hakko Kirin Company, Limited
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP