| Trial ID: | L5381 |
| Source ID: | NCT02577159
|
| Associated Drug: |
Dapagliflozin
|
| Title: |
Dapagliflozin on Hyperlipidemia and Insulin Resistance in Type 2 Diabetic Patients (DAPHNIS Study)
|
| Acronym: |
DAPHNIS
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Dapagliflozin
|
| Outcome Measures: |
Primary: Changes in fasting lipoprotein profiles, Changes in fasting lipoprotein profiles including concentrations of apoA-1, apoA-2, apoB, apoB-48, apoC-2, apoC-3, apoE, RemL-C, free-fatty acids profile, LPL protein mass and lipoprotein profile assessed by the HPLC at four and eight weeks after the administration of dapagliflozin, at four and eight weeks after the administration of dapagliflozin | Secondary: Changes in fasting lipid profiles, Changes in fasting lipid profiles including concentrations of triglyceride(TG), total cholesterol(TC), HDL-cholesterol (HDL-C) and LDL-C at four and eight weeks after the administration of dapagliflozin, at four and eight weeks after the administration of dapagliflozin|Changes in fasting blood glucose and HbA1c, Changes in fasting blood glucose and HbA1c at four and eight weeks after the administration of dapagliflozin, at four and eight weeks after the administration of dapagliflozin|Changes in insulin and adiponectin, Changes in other clinical profiles including concentrations of insulin and adiponectin, at four and eight weeks after the administration of dapagliflozin|Frequency of adverse side effects, Frequency of adverse side effects at four and eight weeks after the administration of dapagliflozin, at four and eight weeks after the administration of dapagliflozin|Changes in biomarkers for renal and hepatic function, Changes in biomarkers for renal and hepatic function at four and eight weeks after the administration of dapagliflozin., four and eight weeks after the administration of dapagliflozin.
|
| Sponsor/Collaborators: |
Sponsor: Osaka University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
50
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2015-07-01
|
| Completion Date: |
2018-08-31
|
| Results First Posted: |
|
| Last Update Posted: |
2018-08-29
|
| Locations: |
Sousei Hospital, Kadoma, Osaka, 5710025, Japan|Osaka Central Hospital, Osaka city, Osaka, 5300001, Japan|Osaka University Hospital, Suita, Osaka, 5650871, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT02577159
|
