None listed
Conditions
Interventions
Drug, Medical Device : Participants who meet the inclusion and exclusion Criteria based on the screening results will be randomized to receive either Enavogliflozin 0.3 mg or placebo, administered ora
Sponsors
The Catholic University of Korea, Uijeongbu St. Mary’s Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or postmenopausal female participants aged =65 years at informed consent 2. Diagnosed with type 2 diabetes mellitus (T2DM) before screening (Visit 1) 3. Laboratory test results at screening (Visit 1) meet eligibility criteria 4. BMI =22 kg/m² at screening (Visit 1)
Exclusion criteria
Exclusion criteria: 1. Diagnosed with type 1 diabetes mellitus (insulin-dependent diabetes) or diabetic ketoacidosis 2. Uncontrolled hypertension 3. Severe hepatic impairment 4. eGFR < 45 mL/min/1.73 m² 5. Low handgrip strength at screening (Visit 1): <28 kg for males, <18 kg for females 6. Previously diagnosed with sarcopenia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c (%) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in HbA1c (%);Change in body weight;Change in muscle mass;Change in body fat mass and lean mass;Change in percentage of body fat and lean mass;Change in total body water content;Change in bone mineral content;Change in skeletal muscle mass index (SMI);Change in handgrip strength (kg);Change in time (seconds) and score on the 5-times sit-to-stand test (5xSTS);Change in K-MoCA scores | — |
Countries
Korea, Republic of
Contacts
Public ContactTae Seo Sohn
The Catholic University of Korea, Uijeongbu St. Mary’s Hospital
Outcome results
None listed