Back to resultsA Clinical Trial to Evaluate the Bone Metabolism and the Blood Sugar of Evogliptin and Dapagliflozin (EVOMETA)
Primary Purpose
Bone Diseases, Metabolic, Diabetes Mellitus, Type 2
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Evogliptin
Dapagliflozin
Sponsored by
About this trial
This is an interventional treatment trial for Bone Diseases, Metabolic focused on measuring osteopenia
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- 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
- 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
Sites / Locations
- GangNeung Asan Hospital
- Inha University Hospital
- Kyung Hee University Hospital
- Soon Chun Hyang University Hospital Seoul
- Konkuk University Medical Center
- Kyung Hee University Hospital at Gangdong
- The Catholic University of Korea, Yeouido St. Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
evogliptin
dapagliflozin
Arm Description
evogliptin 5 mg + metformin, oral administration once a day for 48 weeks
dapagliflozin 10mg + metformin, oral administration once a day for 48 weeks
Outcomes
Primary Outcome Measures
Change of bone density
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)
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)
Change from baseline bone marker P1NP(Procollagen type 1 Aminoterminal Propeptide) at 12 weeks and 48 weeks
Change of 25OHD(25 Hydroxyvitamin D)
Change from baseline bone metabolism indicator 25OHD(25 Hydroxyvitamin D) at 12 weeks and 48 weeks
Change of PTH(Parathyroid Hormone) Intact
Change from baseline bone metabolism indicator PTH(Parathyroid Hormone) Intact at 12 weeks and 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
Change of 24 hour urine calcium
Change from baseline bone metabolism indicator 24 hour urine calcium at 12 weeks and 48 weeks
Change of 24 hour urine phosphate
Change from baseline bone metabolism indicator 24 hour urine phosphate at 12 weeks and 48 weeks
Change of 24 hour urine creatinine
Change from baseline bone metabolism indicator 24 hour urine creatinine at 12 weeks and 48 weeks
Secondary Outcome Measures
Change of HbA1C
Change from baseline HbA1C at 12 weeks and 48 weeks
Change of FBS(Fasting Blood Sugar)
Change from baseline FBS(Fasting Blood Sugar) at 12 weeks and 48 weeks
Change of insulin
Change from baseline insulin at 12 weeks and 48 weeks
Change of c-peptide
Change from baseline c-peptide at 12 weeks and 48 weeks
Change of AGE(Advanced Glycation End Products)
Change from baseline AGE(Advanced Glycation End Products) at 12 weeks and 48 weeks
Change of CGM(Continuous Glucose Monitoring)
Change from baseline CGM(Continuous Glucose Monitoring) at 12 weeks and 48 weeks
Adverse events
Adverse events
Full Information
NCT ID
NCT04706637
First Posted
December 29, 2020
Last Updated
January 10, 2021
Sponsor
Kyung Hee University Hospital at Gangdong
Collaborators
Dong-A ST Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04706637
Brief Title
A Clinical Trial to Evaluate the Bone Metabolism and the Blood Sugar of Evogliptin and Dapagliflozin
Acronym
EVOMETA
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Anticipated)
Primary Completion Date
January 31, 2022 (Anticipated)
Study Completion Date
January 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyung Hee University Hospital at Gangdong
Collaborators
Dong-A ST Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Diseases, Metabolic, Diabetes Mellitus, Type 2
Keywords
osteopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Arm 1: evogliptin 5mg + metformin, oral administration once a day for 48 weeks
Arm 2: dapagliflozin 10mg + metformin, oral administration once a day for 48 weeks
Masking
None (Open Label)
Masking Description
The subject will be randomly assigned to one of the two arms. This is an open-label trial.
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
evogliptin
Arm Type
Experimental
Arm Description
evogliptin 5 mg + metformin, oral administration once a day for 48 weeks
Arm Title
dapagliflozin
Arm Type
Active Comparator
Arm Description
dapagliflozin 10mg + metformin, oral administration once a day for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Evogliptin
Intervention Description
evogliptin 5mg + metformin, oral administration once a day for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Intervention Description
dapagliflozin 10mg + metformin, oral administration once a day for 48 weeks
Primary Outcome Measure Information:
Title
Change of bone density
Description
Change from screening bone density of lumbar spine 1-4, neck of femur and whole femur at 48 weeks
Time Frame
Screening, 48 weeks
Title
Change of CTX(C-terminal telopeptide of type I collagen)
Description
Change from baseline bone marker CTX(C-terminal telopeptide of type I collagen) at 12 weeks and 48 weeks.
Time Frame
Baseline, 12 weeks, 48 weeks
Title
Change of P1NP(Procollagen type 1 Aminoterminal Propeptide)
Description
Change from baseline bone marker P1NP(Procollagen type 1 Aminoterminal Propeptide) at 12 weeks and 48 weeks
Time Frame
Baseline, 12 weeks, 48 weeks
Title
Change of 25OHD(25 Hydroxyvitamin D)
Description
Change from baseline bone metabolism indicator 25OHD(25 Hydroxyvitamin D) at 12 weeks and 48 weeks
Time Frame
Baseline, 12 weeks, 48 weeks
Title
Change of PTH(Parathyroid Hormone) Intact
Description
Change from baseline bone metabolism indicator PTH(Parathyroid Hormone) Intact at 12 weeks and 48 weeks
Time Frame
Baseline, 12 weeks, 48 weeks
Title
Change of FGF23 (Fibroblast growth factor 23)
Description
Change from baseline bone metabolism indicator FGF23(Fibroblast growth factor 23) at 12 weeks and 48 weeks
Time Frame
Baseline, 12 weeks, 48 weeks
Title
Change of 24 hour urine calcium
Description
Change from baseline bone metabolism indicator 24 hour urine calcium at 12 weeks and 48 weeks
Time Frame
Baseline, 12 weeks, 48 weeks
Title
Change of 24 hour urine phosphate
Description
Change from baseline bone metabolism indicator 24 hour urine phosphate at 12 weeks and 48 weeks
Time Frame
Baseline, 12 weeks, 48 weeks
Title
Change of 24 hour urine creatinine
Description
Change from baseline bone metabolism indicator 24 hour urine creatinine at 12 weeks and 48 weeks
Time Frame
Baseline, 12 weeks, 48 weeks
Secondary Outcome Measure Information:
Title
Change of HbA1C
Description
Change from baseline HbA1C at 12 weeks and 48 weeks
Time Frame
Baseline, 12 weeks, 48 weeks
Title
Change of FBS(Fasting Blood Sugar)
Description
Change from baseline FBS(Fasting Blood Sugar) at 12 weeks and 48 weeks
Time Frame
Baseline, 12 weeks, 48 weeks
Title
Change of insulin
Description
Change from baseline insulin at 12 weeks and 48 weeks
Time Frame
Baseline, 12 weeks, 48 weeks
Title
Change of c-peptide
Description
Change from baseline c-peptide at 12 weeks and 48 weeks
Time Frame
Baseline, 12 weeks, 48 weeks
Title
Change of AGE(Advanced Glycation End Products)
Description
Change from baseline AGE(Advanced Glycation End Products) at 12 weeks and 48 weeks
Time Frame
Baseline, 12 weeks, 48 weeks
Title
Change of CGM(Continuous Glucose Monitoring)
Description
Change from baseline CGM(Continuous Glucose Monitoring) at 12 weeks and 48 weeks
Time Frame
Baseline, 12 weeks, 48 weeks
Title
Adverse events
Description
Adverse events
Time Frame
12 weeks, 24 weeks, 36 weeks, 48 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
menopause female patients with osteopenia and type 2 diabetes.
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hoyeon Chung, MD, PhD
Phone
+82-2-440-6124
Email
chy1009@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hoyeon Chung, MD, PhD
Organizational Affiliation
Kyung Hee University Hospital at Gangdong
Official's Role
Principal Investigator
Facility Information:
Facility Name
GangNeung Asan Hospital
City
Gangneung
State/Province
Gangwondo
ZIP/Postal Code
25440
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ha Young Kim, MD, PhD
Phone
+82-33-610-3072
Email
hykimmd@hanmail.net
First Name & Middle Initial & Last Name & Degree
Ha Young Kim, MD, PhD
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seong Bin Hong, MD, PhD
Phone
+82-32-890-3363
Email
sbhongmd@inha.ac.kr
First Name & Middle Initial & Last Name & Degree
Seong Bin Hong, MD, PhD
Facility Name
Kyung Hee University Hospital
City
Seoul
ZIP/Postal Code
02447
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
So Young Park, MD, PhD
Phone
+82-2-958-9431
Email
malcoy@hanmail.net
First Name & Middle Initial & Last Name & Degree
So Young Park, MD, PhD
Facility Name
Soon Chun Hyang University Hospital Seoul
City
Seoul
ZIP/Postal Code
04401
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Won Byun, MD,PhD
Phone
+82-2-710-4240
Email
byundw@schmc.ac.kr
First Name & Middle Initial & Last Name & Degree
Dong Won Byun, MD,PhD
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kee Ho Song, MD, PhD
Phone
+82-2-2030-7533
Email
20050053@kuh.ac.kr
First Name & Middle Initial & Last Name & Degree
Kee Ho Song, MD, PhD
Facility Name
Kyung Hee University Hospital at Gangdong
City
Seoul
ZIP/Postal Code
05278
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hoyeon Chung, MD, PhD
Phone
+82-2-440-6124
Email
chy1009@hotmail.com
First Name & Middle Initial & Last Name & Degree
Hoyeon Chung, MD, PhD
Facility Name
The Catholic University of Korea, Yeouido St. Mary's Hospital
City
Seoul
ZIP/Postal Code
07345
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ki Hyun Baik, MD, PhD
Phone
+82-2-3779-1400
Email
drbkh@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Ki Hyun Baik, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Clinical Trial to Evaluate the Bone Metabolism and the Blood Sugar of Evogliptin and Dapagliflozin
We'll reach out to this number within 24 hrs