Effect of SGLT2 inhibitor, Dapagliflozin combined with or without metformin on body composition in patients with type 2 diabetes

Not Applicable

• Conditions: type 2 diabetes mellitus

• Registration Number: JPRN-UMIN000030446
• Lead Sponsor: St. Marianna University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-01
• Study Completion: 2020-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

Exclusion Criteria

1)patients who administrating less than 750mg of metformin 2)patients who receive insulin injection therapy 3)hypersensitivity to study drugs on this study, 4)severe ketosis and diabetic coma or pre-coma 5)serious infective diseases, serious injury, pre- and per-operation 6)pregnancy, nursing woman or possibly pregnant woman 7)moderate or severe renal dysfunction (eGFR: less than 30 mL/min/1.73m2) 8)patients who receive steroids, growth hormone secretagogue, sex hormone agents 9)patients who are inadequate to enter this study due to the other reasons by physician's judgments

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of the changes in total body muscle mass evaluated by dual-energy x-ray absorptiometry (DXA) before and after 24 weeks between the two groups

Secondary Outcome Measures

Name	Time	Method
Comparison of the changes in quadriceps muscle strength measured by a hand-held dynamometer before and after 24 weeks between the two groups