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

Primary Purpose

Diabetes

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
saxaglipitin
Sponsored by
Kyowa Kirin Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes focused on measuring Diabetes, Type 2

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kyushu Clinical Pharmacology Reserch Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

saxagliptin

Arm Description

5 mg daily for 14days

Outcomes

Primary Outcome Measures

Pharmacokinetics
Concentrations of plasma saxagliptin and BMS-510849
Pharmacodynamics
Plasma DPP4 actyivity Concentrations of blood glucose, C-peptide, insulin and glucagon Plasma active GLP-1 concentration

Secondary Outcome Measures

Safety issues
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)

Full Information

First Posted
July 12, 2010
Last Updated
March 7, 2017
Sponsor
Kyowa Kirin Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01162876
Brief Title
A Clinical Pharmacology Study of Saxagliptin in Patients With Type 2 Diabetes Mellitus
Official Title
A Clinical Pharmacology Study of Saxagliptin in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes
Keywords
Diabetes, Type 2

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
saxagliptin
Arm Type
Experimental
Arm Description
5 mg daily for 14days
Intervention Type
Drug
Intervention Name(s)
saxaglipitin
Intervention Description
oral administration of 5 mg tablet before breakfast for 14 consecutive days
Primary Outcome Measure Information:
Title
Pharmacokinetics
Description
Concentrations of plasma saxagliptin and BMS-510849
Time Frame
daily, up to 42days
Title
Pharmacodynamics
Description
Plasma DPP4 actyivity Concentrations of blood glucose, C-peptide, insulin and glucagon Plasma active GLP-1 concentration
Time Frame
daily, up to 42 days
Secondary Outcome Measure Information:
Title
Safety issues
Description
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)
Time Frame
daily, up to 42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kyushu Clinical Pharmacology Reserch Clinic
City
Fukuoka
Country
Japan

12. IPD Sharing Statement

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

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