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ClinicalTrials.gov ID

NCT04706637

Lead Sponsor

Kyung Hee University Hospital at GangdongOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 4

Enrollment

120Estimated

Last Update Posted

Jan 13, 2021Actual

Start Date

Feb 1, 2021Estimated

Primary Completion Date

Jan 31, 2022Estimated

Completion Date

Jan 31, 2023Estimated

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

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.

• Bone Diseases, Metabolic
• Diabetes Mellitus, Type 2

• Evogliptin
• Dapagliflozin

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Kyung Hee University Hospital at GangdongOTHER

Collaborators

Dong-A ST Co., Ltd.INDUSTRY

sbhongmd@inha.ac.kr+82-32-890-3363

malcoy@hanmail.net+82-2-958-9431

20050053@kuh.ac.kr+82-2-2030-7533