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

March 7, 2017 updated by: Kyowa Kirin Co., Ltd.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan
        • Kyushu Clinical Pharmacology Reserch Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics
Time Frame: daily, up to 42days
Concentrations of plasma saxagliptin and BMS-510849
daily, up to 42days
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
daily, up to 42 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
daily, up to 42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

July 12, 2010

First Submitted That Met QC Criteria

July 14, 2010

First Posted (Estimate)

July 15, 2010

Study Record Updates

Last Update Posted (Actual)

March 9, 2017

Last Update Submitted That Met QC Criteria

March 7, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 262-09-003
  • JapicCTI-101190 (Other Identifier: JAPIC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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