Bone Diseases, MetabolicPhase 4EVOMETANCT04706637
A Clinical Trial to Evaluate the Bone Metabolism and the Blood Sugar of Evogliptin and Dapagliflozin
A Phase 4 study testing Evogliptin and Dapagliflozin in people with Bone Diseases, Metabolic and Diabetes Mellitus, Type 2, run by Kyung Hee University Hospital at Gangdong at 7 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Bone Diseases, Metabolic, Diabetes Mellitus, Type 2
- What is being tested?
- Evogliptin and Dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 1 Feb 2021to 31 Jan 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women between 40 and 70 years of age with type 2 diabetes patients who are not taking diabetes drugs or who are not controlled by blood sugar at 7.0≤HbA1c≤9.0 while taking metformin
- ※ 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
- Lumbar, neck of femur and total femur bone density measurements were -2.4≤T-score≤-1.0
- Obtained written informed consent from a patient
- Patients who can participate during clinical trials and perform all planned trial procedures and visits.
Who cannot join
- A person who has taken a diabetes medications other than metformin within 12 weeks, or who is hypersensitivity to DPP4(dipeptidyl peptidase-4) inhibitors or SGLT2 inhibitors.
- AST(ASpartate Transaminase) or ALT(ALanine Transaminase) exceeds 2 times the upper limit of the normal range in laboratory tests
- Patients with moderate or severe renal impairment, end-stage renal disease (ESRD) or dialysis
- 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
- In the case of osteoporosis medication dosage as follows:
- Patients who have ever used bisphosphonate formulations
Show all 14Show fewer
- Patients who have used female hormones, SERM(Selective Estrogen Receptor Modulator), denosumab, and parathyroid hormone preparations within 12 months
- 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
- Patients who have participated in other clinical trials within 3 months
- Patients with a history of malignant tumors within 5 years
- Those who have a history of hypersensitivity to the main ingredients and additives of the trial drugs
- Patients with type 1 diabetes or diabetic ketoacidosis
- Patients with genetic problems such as galactose intolerance, Lapp deficiency, or glucose-galactose malabsorption
- Any other patient that the investigator has determined is unsuitable for this clinical trial
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
GangNeung Asan Hospital
Gangneung, Gangwondo, 25440
Ha Young Kim, MD, PhD, +82-33-610-3072, hykimmd@hanmail.net
Ha Young Kim, MD, PhD
Inha University Hospital
Incheon, 22332
Seong Bin Hong, MD, PhD, +82-32-890-3363, sbhongmd@inha.ac.kr
Seong Bin Hong, MD, PhD
Kyung Hee University Hospital
Seoul, 02447
So Young Park, MD, PhD, +82-2-958-9431, malcoy@hanmail.net
So Young Park, MD, PhD
Soon Chun Hyang University Hospital Seoul
Seoul, 04401
Dong Won Byun, MD,PhD, +82-2-710-4240, byundw@schmc.ac.kr
Dong Won Byun, MD,PhD
Konkuk University Medical Center
Seoul, 05030
Kee Ho Song, MD, PhD, +82-2-2030-7533, 20050053@kuh.ac.kr
Kee Ho Song, MD, PhD
Kyung Hee University Hospital at Gangdong
Seoul, 05278
Hoyeon Chung, MD, PhD, +82-2-440-6124, chy1009@hotmail.com
Hoyeon Chung, MD, PhD
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, 07345
Ki Hyun Baik, MD, PhD, +82-2-3779-1400, drbkh@catholic.ac.kr
Ki Hyun Baik, MD, PhD
About this study
Official title: A Multicenter Randomized Exploratory Clinical Trial to Evaluate the Effect of Bone Metabolism and the Efficacy of Evogliptin and Dapagliflozin for Blood Sugar in the Menopause Female Patients With Osteopenia and Type 2 Diabetes
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.
Read the detailed description
This clinical trial is 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.
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.
- Being tested
- Evogliptin, Dapagliflozin
- Keywords
- osteopenia
- Medical subject headings
- Bone Diseases, Metabolic, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvogliptinDrug
evogliptin 5mg + metformin, oral administration once a day for 48 weeks
DapagliflozinDrug
dapagliflozin 10mg + metformin, oral administration once a day for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| evogliptin | Experimental | evogliptin 5 mg + metformin, oral administration once a day for 48 weeks Receives: Drug: Evogliptin |
| dapagliflozin | Active comparator | dapagliflozin 10mg + metformin, oral administration once a day for 48 weeks Receives: Drug: Dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of bone density
Change from screening bone density of lumbar spine 1-4, neck of femur and whole femur at 48 weeks
Measured: Screening, 48 weeks
Change of CTX(C-terminal telopeptide of type I collagen)
Change from baseline bone marker CTX(C-terminal telopeptide of type I collagen) at 12 weeks and 48 weeks.
Measured: Baseline, 12 weeks, 48 weeks
Change of P1NP(Procollagen type 1 Aminoterminal Propeptide)
Change from baseline bone marker P1NP(Procollagen type 1 Aminoterminal Propeptide) at 12 weeks and 48 weeks
Measured: Baseline, 12 weeks, 48 weeks
Change of 25OHD(25 Hydroxyvitamin D)
Change from baseline bone metabolism indicator 25OHD(25 Hydroxyvitamin D) at 12 weeks and 48 weeks
Measured: Baseline, 12 weeks, 48 weeks
Change of PTH(Parathyroid Hormone) Intact
Change from baseline bone metabolism indicator PTH(Parathyroid Hormone) Intact at 12 weeks and 48 weeks
Measured: Baseline, 12 weeks, 48 weeks
Change of FGF23 (Fibroblast growth factor 23)
Change from baseline bone metabolism indicator FGF23(Fibroblast growth factor 23) at 12 weeks and 48 weeks
Measured: Baseline, 12 weeks, 48 weeks
Change of 24 hour urine calcium
Change from baseline bone metabolism indicator 24 hour urine calcium at 12 weeks and 48 weeks
Measured: Baseline, 12 weeks, 48 weeks
Change of 24 hour urine phosphate
Change from baseline bone metabolism indicator 24 hour urine phosphate at 12 weeks and 48 weeks
Measured: Baseline, 12 weeks, 48 weeks
Change of 24 hour urine creatinine
Change from baseline bone metabolism indicator 24 hour urine creatinine at 12 weeks and 48 weeks
Measured: Baseline, 12 weeks, 48 weeks
Secondary outcomes (7)
Change of HbA1C
Change from baseline HbA1C at 12 weeks and 48 weeks
Measured: Baseline, 12 weeks, 48 weeks
Change of FBS(Fasting Blood Sugar)
Change from baseline FBS(Fasting Blood Sugar) at 12 weeks and 48 weeks
Measured: Baseline, 12 weeks, 48 weeks
Change of insulin
Change from baseline insulin at 12 weeks and 48 weeks
Measured: Baseline, 12 weeks, 48 weeks
Change of c-peptide
Change from baseline c-peptide at 12 weeks and 48 weeks
Measured: Baseline, 12 weeks, 48 weeks
Change of AGE(Advanced Glycation End Products)
Change from baseline AGE(Advanced Glycation End Products) at 12 weeks and 48 weeks
Measured: Baseline, 12 weeks, 48 weeks
Change of CGM(Continuous Glucose Monitoring)
Change from baseline CGM(Continuous Glucose Monitoring) at 12 weeks and 48 weeks
Measured: Baseline, 12 weeks, 48 weeks
Adverse events
Adverse events
Measured: 12 weeks, 24 weeks, 36 weeks, 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start1 Feb 2021 (estimated)
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone Diseases, MetabolicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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. 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
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyung Hee University Hospital at Gangdong
- Sponsor type
- University, hospital or other
- Collaborators
- Dong-A ST Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Hoyeon Chung, MD, PhD, Principal investigator, Kyung Hee University Hospital at Gangdong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706637
- Sponsor's protocol ID
- EVOMETA-04
- Acronym
- EVOMETA
- Status last verified
- Dec 2020
- First submitted
- 29 Dec 2020
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ryu HJ, Park SY, Kim HY, Byun DW, Song KH, Hong S, Lee J, Baek KH, Chung HY. Effects of Evogliptin and Dapagliflozin on Bone and Glucose Metabolism in Postmenopausal Women with Type 2 Diabetes: A Multicenter Randomized Exploratory Clinical Trial. Diabetes Metab Syndr Obes. 2026 Oct 5;19:618336. doi: 10.2147/DMSO.S618336. eCollection 2026.
PubMed 42857284
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Exploratory Clinical Trial to Evaluate the Effect of Bone Metabolism and the Efficacy of Evogliptin and Dapagliflozin for Blood Sugar in the Menopause Female Patients With Osteopenia and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04706637
- Acronym / sponsor ID
- EVOMETA / EVOMETA-04
- Keywords
- osteopenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Kyung Hee University Hospital at GangdongUniversity, hospital or other
- Collaborators
- Dong-A ST Co., Ltd.
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 13 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This clinical trial is 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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. 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
| Arm | Type | Receives |
|---|---|---|
| evogliptin | Experimental | Drug: Evogliptinevogliptin 5 mg + metformin, oral administration once a day for 48 weeks |
| dapagliflozin | Active comparator | Drug: Dapagliflozindapagliflozin 10mg + metformin, oral administration once a day for 48 weeks |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Postmenopausal women between 40 and 70 years of age with type 2 diabetes patients who are not taking diabetes drugs or who are not controlled by blood sugar at 7.0≤HbA1c≤9.0 while taking metformin
- ※ 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
- Lumbar, neck of femur and total femur bone density measurements were -2.4≤T-score≤-1.0
- Obtained written informed consent from a patient
- Patients who can participate during clinical trials and perform all planned trial procedures and visits.
Key exclusion criteria (14 listed)
- A person who has taken a diabetes medications other than metformin within 12 weeks, or who is hypersensitivity to DPP4(dipeptidyl peptidase-4) inhibitors or SGLT2 inhibitors.
- AST(ASpartate Transaminase) or ALT(ALanine Transaminase) exceeds 2 times the upper limit of the normal range in laboratory tests
- Patients with moderate or severe renal impairment, end-stage renal disease (ESRD) or dialysis
- 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
- In the case of osteoporosis medication dosage as follows:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evogliptinevogliptin 5mg + metformin, oral administration once a day for 48 weeks | Drug | evogliptin |
| Dapagliflozindapagliflozin 10mg + metformin, oral administration once a day for 48 weeks | Drug | dapagliflozin |
Primary outcome
Change of bone density
Time frame: Screening, 48 weeks
Change from screening bone density of lumbar spine 1-4, neck of femur and whole femur at 48 weeks
Change of CTX(C-terminal telopeptide of type I collagen)
Time frame: Baseline, 12 weeks, 48 weeks
Change from baseline bone marker CTX(C-terminal telopeptide of type I collagen) at 12 weeks and 48 weeks.
Change of P1NP(Procollagen type 1 Aminoterminal Propeptide)
Time frame: Baseline, 12 weeks, 48 weeks
Change from baseline bone marker P1NP(Procollagen type 1 Aminoterminal Propeptide) at 12 weeks and 48 weeks
Change of 25OHD(25 Hydroxyvitamin D)
Time frame: Baseline, 12 weeks, 48 weeks
Change from baseline bone metabolism indicator 25OHD(25 Hydroxyvitamin D) at 12 weeks and 48 weeks
Change of PTH(Parathyroid Hormone) Intact
Time frame: Baseline, 12 weeks, 48 weeks
Change from baseline bone metabolism indicator PTH(Parathyroid Hormone) Intact at 12 weeks and 48 weeks
Change of FGF23 (Fibroblast growth factor 23)
Time frame: Baseline, 12 weeks, 48 weeks
Change from baseline bone metabolism indicator FGF23(Fibroblast growth factor 23) at 12 weeks and 48 weeks
Change of 24 hour urine calcium
Time frame: Baseline, 12 weeks, 48 weeks
Change from baseline bone metabolism indicator 24 hour urine calcium at 12 weeks and 48 weeks
Change of 24 hour urine phosphate
Time frame: Baseline, 12 weeks, 48 weeks
Change from baseline bone metabolism indicator 24 hour urine phosphate at 12 weeks and 48 weeks
Change of 24 hour urine creatinine
Time frame: Baseline, 12 weeks, 48 weeks
Change from baseline bone metabolism indicator 24 hour urine creatinine at 12 weeks and 48 weeks
7 secondary outcomes
Change of HbA1C
Time frame: Baseline, 12 weeks, 48 weeks
Change of FBS(Fasting Blood Sugar)
Time frame: Baseline, 12 weeks, 48 weeks
Change of insulin
Time frame: Baseline, 12 weeks, 48 weeks
Change of c-peptide
Time frame: Baseline, 12 weeks, 48 weeks
Change of AGE(Advanced Glycation End Products)
Time frame: Baseline, 12 weeks, 48 weeks
Change of CGM(Continuous Glucose Monitoring)
Time frame: Baseline, 12 weeks, 48 weeks
Adverse events
Time frame: 12 weeks, 24 weeks, 36 weeks, 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Derived from this study: PubMed 42857284Ryu HJ, Park SY, Kim HY, Byun DW, Song KH, Hong S, Lee J, Baek KH, Chung HY. Effects of Evogliptin and Dapagliflozin on Bone and Glucose Metabolism in Postmenopausal Women with Type 2 Diabetes: A Multicenter Randomized Exploratory Clinical Trial. Diabetes Metab Syndr Obes. 2026 Oct 5;19:618336. doi: 10.2147/DMSO.S618336. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hoyeon Chung, MD, PhD principal investigator
Kyung Hee University Hospital at Gangdong
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Evogliptin and Dapagliflozin in people with Bone Diseases, Metabolic and Diabetes Mellitus, Type 2, run by Kyung Hee University Hospital at Gangdong at 7 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hoyeon Chung, MD, PhD (+82-2-440-6124, chy1009@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of bone density (time frame: Screening, 48 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04706637, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.