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

NCT04706637 | Unknown Phase 4

• 1 other identifier: EVOMETA-04
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 7

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.

Conditions

Bone Diseases, Metabolic; Diabetes Mellitus, Type 2

Keywords

osteopenia

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (7)

• Change of HbA1C

  Baseline, 12 weeks, 48 weeks

• Change of FBS(Fasting Blood Sugar)

  Baseline, 12 weeks, 48 weeks

• Change of insulin

  Baseline, 12 weeks, 48 weeks

• Change of c-peptide

  Baseline, 12 weeks, 48 weeks

• Change of AGE(Advanced Glycation End Products)

  Baseline, 12 weeks, 48 weeks

Study Arms (2)

evogliptin

EXPERIMENTAL

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

Drug: Evogliptin

dapagliflozin

ACTIVE COMPARATOR

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

Drug: Dapagliflozin

Interventions

Evogliptin DRUG

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

evogliptin

Dapagliflozin DRUG

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

dapagliflozin

Eligibility Criteria

• Age: 40 Years - 70 Years
• Gender Eligibility Details: menopause female patients with osteopenia and type 2 diabetes.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyung Hee University Hospital at Gangdong: lead
• Dong-A ST Co., Ltd.: collaborator

Study Sites (7)

GangNeung Asan Hospital

Gangneung, Gangwondo, 25440, South Korea

Location

Inha University Hospital

Incheon, 22332, South Korea

Location

Kyung Hee University Hospital

Seoul, 02447, South Korea

Location

Soon Chun Hyang University Hospital Seoul

Seoul, 04401, South Korea

Location

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, 05278, South Korea

Location

The Catholic University of Korea, Yeouido St. Mary's Hospital

Seoul, 07345, South Korea

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Diabetes Mellitus, Type 2

Interventions

4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one; dapagliflozin

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases

Study Officials

• Hoyeon Chung, MD, PhD

  Kyung Hee University Hospital at Gangdong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hoyeon Chung, MD, PhD

CONTACT

+82-2-440-6124; chy1009@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The subject will be randomly assigned to one of the two arms. This is an open-label trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: January 13, 2021
• Study Start: February 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2023
• Last Updated: January 13, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (7)