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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 (Responsible Party):
Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier:
NCT01162876
First received: July 12, 2010
Last updated: March 7, 2017
Last verified: March 2017
July 12, 2010
March 7, 2017
July 2010
November 2010   (Final data collection date for primary outcome measure)
  • Pharmacokinetics [ Time Frame: daily, up to 42days ]
    Concentrations of plasma saxagliptin and BMS-510849
  • 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
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 ]
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
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Other
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
Sexes Eligible for Study: All
20 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01162876
262-09-003
JapicCTI-101190 ( Other Identifier: JAPIC )
No
Not Provided
Not Provided
Not Provided
Kyowa Hakko Kirin Co., Ltd
Kyowa Hakko Kirin Co., Ltd
Not Provided
Not Provided
Kyowa Hakko Kirin Co., Ltd
March 2017

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