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

Diabetes Mellitus, Type 2 Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04706637
• Other study ID #: EVOMETA-04
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 1, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: December 2020
• Source: Kyung Hee University Hospital at Gangdong
• Contact: Hoyeon Chung, MD, PhD
• Phone: +82-2-440-6124
• Email: chy1009[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

1. 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

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:

1. 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.

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

Related Conditions & MeSH terms

• Bone Diseases
• Bone Diseases, Metabolic
• Diabetes Mellitus, Type 2
• Metabolic Diseases

Intervention

Drug:
• Evogliptin
evogliptin 5mg + metformin, oral administration once a day for 48 weeks
• Dapagliflozin
dapagliflozin 10mg + metformin, oral administration once a day for 48 weeks

Locations

Country	Name	City	State
Korea, Republic of	GangNeung Asan Hospital	Gangneung	Gangwondo
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul
Korea, Republic of	Soon Chun Hyang University Hospital Seoul	Seoul
Korea, Republic of	The Catholic University of Korea, Yeouido St. Mary's Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Kyung Hee University Hospital at Gangdong	Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of bone density	Change from screening bone density of lumbar spine 1-4, neck of femur and whole femur at 48 weeks	Screening, 48 weeks
Primary	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.	Baseline, 12 weeks, 48 weeks
Primary	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	Baseline, 12 weeks, 48 weeks
Primary	Change of 25OHD(25 Hydroxyvitamin D)	Change from baseline bone metabolism indicator 25OHD(25 Hydroxyvitamin D) at 12 weeks and 48 weeks	Baseline, 12 weeks, 48 weeks
Primary	Change of PTH(Parathyroid Hormone) Intact	Change from baseline bone metabolism indicator PTH(Parathyroid Hormone) Intact at 12 weeks and 48 weeks	Baseline, 12 weeks, 48 weeks
Primary	Change of FGF23 (Fibroblast growth factor 23)	Change from baseline bone metabolism indicator FGF23(Fibroblast growth factor 23) at 12 weeks and 48 weeks	Baseline, 12 weeks, 48 weeks
Primary	Change of 24 hour urine calcium	Change from baseline bone metabolism indicator 24 hour urine calcium at 12 weeks and 48 weeks	Baseline, 12 weeks, 48 weeks
Primary	Change of 24 hour urine phosphate	Change from baseline bone metabolism indicator 24 hour urine phosphate at 12 weeks and 48 weeks	Baseline, 12 weeks, 48 weeks
Primary	Change of 24 hour urine creatinine	Change from baseline bone metabolism indicator 24 hour urine creatinine at 12 weeks and 48 weeks	Baseline, 12 weeks, 48 weeks
Secondary	Change of HbA1C	Change from baseline HbA1C at 12 weeks and 48 weeks	Baseline, 12 weeks, 48 weeks
Secondary	Change of FBS(Fasting Blood Sugar)	Change from baseline FBS(Fasting Blood Sugar) at 12 weeks and 48 weeks	Baseline, 12 weeks, 48 weeks
Secondary	Change of insulin	Change from baseline insulin at 12 weeks and 48 weeks	Baseline, 12 weeks, 48 weeks
Secondary	Change of c-peptide	Change from baseline c-peptide at 12 weeks and 48 weeks	Baseline, 12 weeks, 48 weeks
Secondary	Change of AGE(Advanced Glycation End Products)	Change from baseline AGE(Advanced Glycation End Products) at 12 weeks and 48 weeks	Baseline, 12 weeks, 48 weeks
Secondary	Change of CGM(Continuous Glucose Monitoring)	Change from baseline CGM(Continuous Glucose Monitoring) at 12 weeks and 48 weeks	Baseline, 12 weeks, 48 weeks
Secondary	Adverse events	Adverse events	12 weeks, 24 weeks, 36 weeks, 48 weeks