Back to resultsEffect of Evogliptin on Bone Metabolism in Human
Primary Purpose
Diabetes Mellitus, Type 2, Osteoporosis
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Evogliptin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- Postmenopausal healthy women (at least 5 years)
- BMI 18~30 kg/m2
Exclusion Criteria:
- Presence or history of hypersensitivity or allergic reactions to any drug
- Clinically relevant abnormal medical history or present disease
- Presence or history of drug abuse
- Participation in other clinical trial within 2 months before dose.
- Bood donation during 2 months or apheresis during 1 month before the study.
- Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication or vitamin substances within 1 week before dose.
- Use of any drug which can affect bone metabolism such as sex hormones or their receptor related medicine, calcitonin or parathyroid hormone related medicine, systemic corticosteroid, bisphosphate, or etc.
- Smoking of more than 10 cigarettes/days within 3 months before first dose.
- Use of alcohol over 21 units/weeks
- Subject judged not eligible for study participation by investigator.
Sites / Locations
- Dongguk University Ilsan HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Evogliptin 10 mg
Arm Description
Single oral administration of 2 tablets of evogliptin 5 mg with water 250 mL
Outcomes
Primary Outcome Measures
Serum concentration of C-terminal telopeptide after treatment in comparison with the baseline
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02587975
Brief Title
Effect of Evogliptin on Bone Metabolism in Human
Official Title
Pharmacodynamics Study to Investigate the Effect of Evogliptin on Bone Metabolism in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
DongGuk University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed to measure the effect of evogliptin on bone metabolism in healthy volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Evogliptin 10 mg
Arm Type
Experimental
Arm Description
Single oral administration of 2 tablets of evogliptin 5 mg with water 250 mL
Intervention Type
Drug
Intervention Name(s)
Evogliptin
Other Intervention Name(s)
DA-1229, Suganon
Intervention Description
10 mg
Primary Outcome Measure Information:
Title
Serum concentration of C-terminal telopeptide after treatment in comparison with the baseline
Time Frame
Predose and 1, 2, 3, 4, 6, 14, 20, 24 h postdose on Day 1 and Day 2
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Postmenopausal healthy women (at least 5 years)
BMI 18~30 kg/m2
Exclusion Criteria:
Presence or history of hypersensitivity or allergic reactions to any drug
Clinically relevant abnormal medical history or present disease
Presence or history of drug abuse
Participation in other clinical trial within 2 months before dose.
Bood donation during 2 months or apheresis during 1 month before the study.
Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication or vitamin substances within 1 week before dose.
Use of any drug which can affect bone metabolism such as sex hormones or their receptor related medicine, calcitonin or parathyroid hormone related medicine, systemic corticosteroid, bisphosphate, or etc.
Smoking of more than 10 cigarettes/days within 3 months before first dose.
Use of alcohol over 21 units/weeks
Subject judged not eligible for study participation by investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Namyi Gu, MD, PhD
Phone
+82-31-961-8440
Email
namyi.gu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Namyi Gu, MD, PhD
Organizational Affiliation
Dongguk University College of Medicine and Ilsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dongguk University Ilsan Hospital
City
Goyang
State/Province
Gyeonggi
ZIP/Postal Code
410-773
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Namyi Gu, MD, PhD
Phone
+82-31-961-8440
Email
namyi.gu@gmail.com
12. IPD Sharing Statement
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Effect of Evogliptin on Bone Metabolism in Human
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