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A Clinical Trial to Evaluate the Bone Metabolism and the Blood Sugar of Evogliptin and Dapagliflozin

NCT04706637 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-01-13

No results posted yet for this study

Summary

This multi-center, randomized and exploratory clinical trial is designed to evaluate the effect of bone metabolism and blood sugar of evogliptin and dapagliflozin in the menopause female patients with osteopenia and type 2 diabetes.

The trial will evaluate bone metabolism (bone markers and bone density) and blood sugar (AGE and glucose variability) after 12 weeks and 48 weeks.

This clinical trial conducts in two arms, and each arm recruits 60 subjects.

Conditions

  • Bone Diseases, Metabolic
  • Diabetes Mellitus, Type 2

Interventions

DRUG

Evogliptin

evogliptin 5mg + metformin, oral administration once a day for 48 weeks

DRUG

Dapagliflozin

dapagliflozin 10mg + metformin, oral administration once a day for 48 weeks

Sponsors & Collaborators

  • Dong-A ST Co., Ltd.

    collaborator INDUSTRY

  • Kyung Hee University Hospital at Gangdong

    lead OTHER

Principal Investigators

  • Hoyeon Chung, MD, PhD · Kyung Hee University Hospital at Gangdong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2022-01-31
Completion
2023-01-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04706637 on ClinicalTrials.gov