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

Lead Sponsor: Kyung Hee University Hospital at Gangdong

Collaborator: Dong-A ST Co., Ltd.

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.

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

Intervention Type: Drug

Intervention Name: Evogliptin

Description: evogliptin 5mg + metformin, oral administration once a day for 48 weeks

Arm Group Label: evogliptin

Intervention Type: Drug

Intervention Name: Dapagliflozin

Description: dapagliflozin 10mg + metformin, oral administration once a day for 48 weeks

Arm Group Label: dapagliflozin

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

Gender: Female

Gender Based: Yes

Gender Description: menopause female patients with osteopenia and type 2 diabetes.

Minimum Age: 40 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Last Name: Hoyeon Chung, MD, PhD

Phone: +82-2-440-6124

Email: [email protected]

Korea, Republic of

December 2020

Type: Sponsor

• osteopenia

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

Label: evogliptin

Type: Experimental

Description: evogliptin 5 mg + metformin, oral administration once a day for 48 weeks

Label: dapagliflozin

Type: Active Comparator

Description: dapagliflozin 10mg + metformin, oral administration once a day for 48 weeks

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention 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

Primary Purpose: Treatment

Masking: None (Open Label)

Masking Description: The subject will be randomly assigned to one of the two arms. This is an open-label trial.