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

Tracking Information
First Received Date ^ICMJE	July 12, 2010
Last Updated Date	June 15, 2011
Start Date ^ICMJE	July 2010
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 14, 2010)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01162876 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 14, 2010)	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)
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Clinical Pharmacology Study of Saxagliptin in Patients With Type 2 Diabetes Mellitus
Official Title ^ICMJE	A Clinical Pharmacology Study of Saxagliptin in Patients With Type 2 Diabetes Mellitus
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label
Condition ^ICMJE	Diabetes
Intervention ^ICMJE	Drug: saxaglipitin oral administration of 5 mg tablet before breakfast for 14 consecutive days
Study Arm (s)	Experimental: saxagliptin 5 mg daily for 14days Intervention: Drug: saxaglipitin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	20
Completion Date	November 2010
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients who meet all of the following criteria will be included: HbA1c level ≥7.0% and < 9.0% Fasting glucose level ≥130mg/dL and <210mg/dL Patients who are capable of giving informed consent 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
Gender	Both
Ages	20 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Japan

Administrative Information
NCT Number ^ICMJE	NCT01162876
Other Study ID Numbers ^ICMJE	262-09-003, JapicCTI-101190
Has Data Monitoring Committee	No
Responsible Party	Katsuhisa Saito, Senior Operating Officer, Director, Otsuka Pharmaceutical Co., Ltd.
Study Sponsor ^ICMJE	Otsuka Pharmaceutical Co., Ltd.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Otsuka Pharmaceutical Co., Ltd.
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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