A Clinical Trial to Evaluate the Bone Metabolism and the Blood Sugar of Evogliptin and Dapagliflozin
NCT ID: NCT04706637
Last Updated: 2021-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2021-02-01
2023-01-31
Brief Summary
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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.
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Detailed Description
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Bone metabolism (bone markers and bone density) and blood sugar (AGE and glucose variability) after 12 weeks and 48 weeks will be evaluated.
This clinical trial conducts in two arms, and each arm recruits 60 subjects. If a subject voluntarily agrees to participate and meets the inclusion and exclusion criteria for the clinical trial, the subject will be randomly assigned to one of the two arms.
The total period after the subject enrollment is 48 weeks, and a total of six visits are made with screening, baseline, 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Efficacy evaluation will be carried out changes on blood sugar, bone markers and density and after 12 and 48 weeks.
The results of this study are intended to be a reference to future clinical trials.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
1. Arm 1: evogliptin 5mg + metformin, oral administration once a day for 48 weeks
2. Arm 2: dapagliflozin 10mg + metformin, oral administration once a day for 48 weeks
TREATMENT
NONE
Study Groups
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evogliptin
evogliptin 5 mg + metformin, oral administration once a day for 48 weeks
Evogliptin
evogliptin 5mg + metformin, oral administration once a day for 48 weeks
dapagliflozin
dapagliflozin 10mg + metformin, oral administration once a day for 48 weeks
Dapagliflozin
dapagliflozin 10mg + metformin, oral administration once a day for 48 weeks
Interventions
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Evogliptin
evogliptin 5mg + metformin, oral administration once a day for 48 weeks
Dapagliflozin
dapagliflozin 10mg + metformin, oral administration once a day for 48 weeks
Eligibility Criteria
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Inclusion Criteria
※ Menopause corresponds when one or more of the following three conditions are satisfied. (1) 12 months of amenorrhea (2) In the case of FSH≥40 mIL(milli-international unit)/mL in women over 50 years who have undergone a hysterectomy or 6 months of amenorrhea (3) Patients 6 weeks after ovariectomy
2. Lumbar, neck of femur and total femur bone density measurements were -2.4≤T-score≤-1.0
3. Obtained written informed consent from a patient
4. Patients who can participate during clinical trials and perform all planned trial procedures and visits.
Exclusion Criteria
2. AST(ASpartate Transaminase) or ALT(ALanine Transaminase) exceeds 2 times the upper limit of the normal range in laboratory tests
3. Patients with moderate or severe renal impairment, end-stage renal disease (ESRD) or dialysis
4. Patients whose eGFR(epidermal growth factor receptor) calculated using MDRD formula within 4 weeks before screening or at screening is less than 60 mL/minute/1.73 m2
5. In the case of osteoporosis medication dosage as follows:
* Patients who have ever used bisphosphonate formulations
* Patients who have used female hormones, SERM(Selective Estrogen Receptor Modulator), denosumab, and parathyroid hormone preparations within 12 months
6. Have bone or mineral metabolic diseases or have received treatment that affects them (1) Steroid; - Oral steroid 2.5mg or more has been continuously taken for more than 3 months from the date of consent - Continuous use of systemic or inhaled steroids for more than 3 months from the date of consent (2) Taking diuretics (3) Patients at risk for secondary osteoporosis
7. Patients who have participated in other clinical trials within 3 months
8. Patients with a history of malignant tumors within 5 years
9. Those who have a history of hypersensitivity to the main ingredients and additives of the trial drugs
10. Patients with type 1 diabetes or diabetic ketoacidosis
11. Patients with genetic problems such as galactose intolerance, Lapp deficiency, or glucose-galactose malabsorption
12. Any other patient that the investigator has determined is unsuitable for this clinical trial
40 Years
70 Years
FEMALE
No
Sponsors
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Dong-A ST Co., Ltd.
INDUSTRY
Kyung Hee University Hospital at Gangdong
OTHER
Responsible Party
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Principal Investigators
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Hoyeon Chung, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kyung Hee University Hospital at Gangdong
Locations
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GangNeung Asan Hospital
Gangneung, Gangwondo, South Korea
Inha University Hospital
Incheon, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Soon Chun Hyang University Hospital Seoul
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Kyung Hee University Hospital at Gangdong
Seoul, , South Korea
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EVOMETA-04
Identifier Type: -
Identifier Source: org_study_id
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