Effects of Dapagliflozin on Hyperlipidemia, Glycemic Control and Insulin Resistance in Type 2 Diabetic Patients (DAPHNIS study)

Phase 4

• Conditions: type 2 diabetes mellitus

• Registration Number: JPRN-UMIN000018871
• Lead Sponsor: Osaka University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-01
• Study Completion: 2017-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

Exclusion Criteria

1. Type 1 diabetes mellitus 2. Moderate or severe renal dysfunction (eGFR<45 ml/min/1.73m2 or hemodialysis) 3. Severe hepatic insufficiency (AST and/or ALT >3x upper limit of normal) 4. Adrenal insufficiency or pituitary gland dysfunction 5. Malnourishment, starvation, irregular dietary intake, poor dietary intake, debilitating condition or a severe muscle movement 6. Volume depleted patients; concomitant medication such as loop diuretics. 7. Excessive alcohol intake (>60g daily) 8. SGLT2 inhibitors such as dapagliflozin are already administered 9. Contraindication with dapagliflozin 10. Start a new medication of statins, fibratesm ezetimibe or probucol within a month 11. Females who are likely to be pregnant, during pregnancy or lactating 12. Participants in other clinical trials 13. Inability to communicate and comply with all study requirements.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To examine changes of fasting lipoprotein profile by the administration of dapagliflozin; Concentrations of apoB-48 and RemL-C by examining before and 4 and 8 weeks after the administration of dapagliflozin.

Secondary Outcome Measures

Name	Time	Method
Following points will be examined before and 4 and 8 weeks after the administration of dapagliflozin. 1.To examine changes of fasting glucose and HbA1c (NGSP) level by the administration of dapagliflozin 2.To examine changes of fasting lipid profile by the administration of dapagliflozin; Concentrations of TG, TC, HDL-C and LDL-C 3.To examine changes of fractions of free fatty acids, protein mass of LPL, and lipoprotein profile assessed by the HPLC by the administration of dapagliflozin 4.To examine changes of biomarkers for renal and hepatic function by the administration of dapagliflozin 5.To examine the frequency of adverse effects by the administration of dapagliflozin