Phase 4
Completed N=121
Foxiga Korea Local Phase 4 Study
Source: ClinicalTrials.gov NCT02564926 ↗Enrolled (actual)
121
Serious AEs
9.9%
Results posted
Aug 2019
Primary outcomePrimary: Adjusted Mean Changes From Baseline in Total Body Fat Mass by DXA Scan — -1485.69; 1096.34 grams — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
To evaluate the effect of dapagliflozin on body composition in Korean T2DM subjects.12-month, randomised, open-label, parallel-group, multi-centre phase IV study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Changes From Baseline in Total Body Fat Mass by DXA Scan |
-1485.69; 1096.34 | <0.001 sig |
| PRIMARY Adjusted Mean Changes From Baseline in Percentage of Total Body Fat Assessed by DXA Scan |
-1.21; 0.73 | <0.001 sig |
| SECONDARY Adjusted Mean Change in HbA1c at Week 52 |
-1.00; -0.54 | 0.014 sig |
| SECONDARY HbA1c <7.0% at Week 52 |
27; 22 | 0.343 |
| SECONDARY Adjusted Mean Change in Fasting Blood Sugar (FBS) at Week 52 |
-30.94; -12.70 | 0.006 sig |
| SECONDARY Adjusted Mean Change in Total Body Weight at Week 52 |
-2.4; 1.3 | <0.001 sig |
| SECONDARY Adjusted Mean Change in Waist Circumference at Week 52 |
-2.37; -0.16 | 0.006 sig |
| SECONDARY Adjusted Mean Change in Body Mass Index (BMI) at Week 52 |
-0.91; 0.46 | <0.001 sig |
| SECONDARY Adjusted Mean Change in Systolic Blood Pressure (SBP) at Week 52 |
-2.18; 4.63 | 0.002 sig |
| SECONDARY Adjusted Mean Change in Diastolic Blood Pressure (DBP) at Week 52 |
-0.25; 2.36 | 0.110 |
| SECONDARY Adjusted Mean Change in Visceral Adipose Tissue (VAT) Area at Week 52 |
-16.06; 1.48 | 0.002 sig |
| SECONDARY Adjusted Mean Change in Subcutaneous Adipose Tissue (SAT) Area at Week 52 |
-5.41; 12.98 | <0.001 sig |
| SECONDARY Adjusted Mean Change in Visceral to Subcutaneous Adipose Tissue Ratio at Week 52 |
-0.05; -0.02 | 0.503 |
| SECONDARY Adjusted Mean Change in Lean Body Mass at Week 52 |
-1.1; 0.2 | <0.001 sig |
| SECONDARY Adjusted Mean Change in Adinopectin at Week 52 |
1746.66; 1088.95 | 0.044 sig |
| SECONDARY Adjusted Mean Change in High Sensitivity C-Reactive Protein (hsCRP) at Week 52 |
-0.51; -0.39 | 0.756 |
Eligibility Criteria
Inclusion Criteria
- Adults with T2DM (Male or female, ≥ 19 and ≤ 75 yrs)
- Patients in insufficient glycemic control (HbA1c > 7.5% and 8 weeks prior to randomization
- Written informed consent
- WOCBP must take precautions to avoid pregnancy throughout the study and for 4 weeks after intake of the last dose.
- WOCBP must have a negative urine pregnancy test at screening visit WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal.
- WOCBP must be willing to use a medically accepted method of contraception that is considered reliable in the judgment of the Investigator.
Exclusion Criteria
- Type 1 diabetes or history of diabetic ketoacidosis
- Pregnant or breast-feeding patients
- eGFR 3 X upper limits of normal) on visit 1.
- Acute coronary syndrome, stroke or TIA within 3 months prior to randomization
- Bariatric surgery within 2 years; treatment of anti-obesity drugs 3 months prior to randomization; any treatment leading to unstable body weight. (Unstable body weight is considered reliable in the judgment of the Investigator.)
- History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
- History of any other malignancy within 5 years (with the exception of successfully treated non-melanoma skin cancers)
- History of alcohol or drug abuse judged by physician within 3 months prior to randomization
- Concomitant participation in any other clinical study.
Data sourced from ClinicalTrials.gov (NCT02564926). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.