Effect of Evogliptin on Bone Metabolism in Human

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Pharmacodynamics Study to Investigate the Effect of Evogliptin on Bone Metabolism in Healthy Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02587975
• Other study ID #: DUMC-EVOG-BONE
• Status: Recruiting
• Phase: Phase 4
• First received: October 26, 2015
• Last updated: July 21, 2016
• Start date: June 2016
• Est. completion date: March 2017

Study information

• Verified date: July 2016
• Source: DongGuk University
• Contact: Namyi Gu, MD, PhD
• Phone: +82-31-961-8440
• Email: namyi.gu[@]gmail.com
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

This study is designed to measure the effect of evogliptin on bone metabolism in healthy volunteers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Osteoporosis

Intervention

Drug:
• Evogliptin
10 mg

Locations

Country	Name	City	State
Korea, Republic of	Dongguk University Ilsan Hospital	Goyang	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
DongGuk University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum concentration of C-terminal telopeptide after treatment in comparison with the baseline		Predose and 1, 2, 3, 4, 6, 14, 20, 24 h postdose on Day 1 and Day 2	No