Trial Outcomes & Findings for Foxiga Korea Local Phase 4 Study (NCT NCT02564926)
NCT ID: NCT02564926
Last Updated: 2019-08-20
Results Overview
Adjusted mean changes in total body fat mass from baseline using DXA scan in 52 weeks after the start of the treatment
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
125 participants
Primary outcome timeframe
From baseline to Week 52
Results posted on
2019-08-20
Participant Flow
First patient enrolled: 05 January 2016 Last patient last visit: 15 January 2018
178 patients provided informed consent. 121 patients received study treatment and were included in the SAF population. 112 patients received study treatment and had at least one post-baseline primary efficacy assessment and were included in the FAS population (56 patients in each treatment group).
Participant milestones
| Measure |
Dapagliflozin
Dapagliflozin 10mg + Metformin 1000mg
|
Glimepiride
Glimepiriide 1-2mg + Metformin 1000mg
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
61
|
|
Overall Study
COMPLETED
|
52
|
54
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Foxiga Korea Local Phase 4 Study
Baseline characteristics by cohort
| Measure |
Dapagliflozin
n=60 Participants
Dapagliflozin 10mg + Metformin 1000mg
|
Glimepiride
n=61 Participants
Glimepiriide 1-2mg + Metformin 1000mg
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 9.09 • n=93 Participants
|
55.7 years
STANDARD_DEVIATION 10.24 • n=4 Participants
|
55.2 years
STANDARD_DEVIATION 9.66 • n=27 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
57 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
64 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Korean
|
60 Participants
n=93 Participants
|
61 Participants
n=4 Participants
|
121 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: From baseline to Week 52Adjusted mean changes in total body fat mass from baseline using DXA scan in 52 weeks after the start of the treatment
Outcome measures
| Measure |
Dapagliflozin
n=56 Participants
Dapagliflozin 10mg + Metformin 1000mg
|
Glimepiride
n=56 Participants
Glimepiriide 1-2mg + Metformin 1000mg
|
|---|---|---|
|
Adjusted Mean Changes From Baseline in Total Body Fat Mass by DXA Scan
|
-1485.69 grams
Interval -2025.543 to -945.844
|
1096.34 grams
Interval 556.489 to 1636.187
|
PRIMARY outcome
Timeframe: From baseline to Week 52Adjusted mean percent changes in total body fat mass from baseline using DXA scan in 52 weeks after the start of the treatment
Outcome measures
| Measure |
Dapagliflozin
n=56 Participants
Dapagliflozin 10mg + Metformin 1000mg
|
Glimepiride
n=56 Participants
Glimepiriide 1-2mg + Metformin 1000mg
|
|---|---|---|
|
Adjusted Mean Changes From Baseline in Percentage of Total Body Fat Assessed by DXA Scan
|
-1.21 percent change
Interval -1.821 to -0.604
|
0.73 percent change
Interval 0.123 to 1.341
|
SECONDARY outcome
Timeframe: From baseline to Week 52Adjusted Mean Change in HbA1c at Week 52
Outcome measures
| Measure |
Dapagliflozin
n=56 Participants
Dapagliflozin 10mg + Metformin 1000mg
|
Glimepiride
n=56 Participants
Glimepiriide 1-2mg + Metformin 1000mg
|
|---|---|---|
|
Adjusted Mean Change in HbA1c at Week 52
|
-1.00 percentages
Interval -1.259 to -0.745
|
-0.54 percentages
Interval -0.802 to -0.287
|
SECONDARY outcome
Timeframe: 52 weeksHbA1c \<7.0% at Week 52
Outcome measures
| Measure |
Dapagliflozin
n=56 Participants
Dapagliflozin 10mg + Metformin 1000mg
|
Glimepiride
n=56 Participants
Glimepiriide 1-2mg + Metformin 1000mg
|
|---|---|---|
|
HbA1c <7.0% at Week 52
Count of participants that achieved the response
|
27 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: From baseline to Week 52Adjusted Mean Change in Fasting Blood Sugar (FBS) at Week 52
Outcome measures
| Measure |
Dapagliflozin
n=56 Participants
Dapagliflozin 10mg + Metformin 1000mg
|
Glimepiride
n=56 Participants
Glimepiriide 1-2mg + Metformin 1000mg
|
|---|---|---|
|
Adjusted Mean Change in Fasting Blood Sugar (FBS) at Week 52
|
-30.94 mg/dL
Interval -40.084 to -21.8
|
-12.70 mg/dL
Interval -21.786 to -3.607
|
SECONDARY outcome
Timeframe: From baseline to Week 52Adjusted Mean Change in Total Body Weight at Week 52
Outcome measures
| Measure |
Dapagliflozin
n=56 Participants
Dapagliflozin 10mg + Metformin 1000mg
|
Glimepiride
n=56 Participants
Glimepiriide 1-2mg + Metformin 1000mg
|
|---|---|---|
|
Adjusted Mean Change in Total Body Weight at Week 52
|
-2.4 kg
Interval -3.104 to -1.664
|
1.3 kg
Interval 0.545 to 1.984
|
SECONDARY outcome
Timeframe: From baseline to Week 52Adjusted Mean Change in Waist Circumference at Week 52
Outcome measures
| Measure |
Dapagliflozin
n=56 Participants
Dapagliflozin 10mg + Metformin 1000mg
|
Glimepiride
n=56 Participants
Glimepiriide 1-2mg + Metformin 1000mg
|
|---|---|---|
|
Adjusted Mean Change in Waist Circumference at Week 52
|
-2.37 cm
Interval -3.48 to -1.253
|
-0.16 cm
Interval -1.271 to 0.957
|
SECONDARY outcome
Timeframe: From baseline to Week 52Adjusted Mean Change in Body Mass Index (BMI) at Week 52
Outcome measures
| Measure |
Dapagliflozin
n=56 Participants
Dapagliflozin 10mg + Metformin 1000mg
|
Glimepiride
n=56 Participants
Glimepiriide 1-2mg + Metformin 1000mg
|
|---|---|---|
|
Adjusted Mean Change in Body Mass Index (BMI) at Week 52
|
-0.91 kg/m^2
Interval -1.172 to -0.64
|
0.46 kg/m^2
Interval 0.194 to 0.726
|
SECONDARY outcome
Timeframe: From baseline to Week 52Adjusted Mean Change in Systolic Blood Pressure (SBP) at Week 52
Outcome measures
| Measure |
Dapagliflozin
n=56 Participants
Dapagliflozin 10mg + Metformin 1000mg
|
Glimepiride
n=56 Participants
Glimepiriide 1-2mg + Metformin 1000mg
|
|---|---|---|
|
Adjusted Mean Change in Systolic Blood Pressure (SBP) at Week 52
|
-2.18 mmHg
Interval -5.123 to 0.766
|
4.63 mmHg
Interval 1.682 to 7.57
|
SECONDARY outcome
Timeframe: From baseline to Week 52Adjusted Mean Change in Diastolic Blood Pressure (DBP) at Week 52
Outcome measures
| Measure |
Dapagliflozin
n=56 Participants
Dapagliflozin 10mg + Metformin 1000mg
|
Glimepiride
n=56 Participants
Glimepiriide 1-2mg + Metformin 1000mg
|
|---|---|---|
|
Adjusted Mean Change in Diastolic Blood Pressure (DBP) at Week 52
|
-0.25 mmHg
Interval -2.523 to 2.023
|
2.36 mmHg
Interval 0.092 to 4.638
|
SECONDARY outcome
Timeframe: From baseline to Week 52Adjusted Mean Change in Visceral Adipose Tissue (VAT) area at Week 52
Outcome measures
| Measure |
Dapagliflozin
n=56 Participants
Dapagliflozin 10mg + Metformin 1000mg
|
Glimepiride
n=56 Participants
Glimepiriide 1-2mg + Metformin 1000mg
|
|---|---|---|
|
Adjusted Mean Change in Visceral Adipose Tissue (VAT) Area at Week 52
|
-16.06 cm^2
Interval -23.806 to -8.317
|
1.48 cm^2
Interval -6.407 to 9.377
|
SECONDARY outcome
Timeframe: From baseline to Week 52Adjusted Mean Change in Subcutaneous Adipose Tissue (SAT) area at Week 52
Outcome measures
| Measure |
Dapagliflozin
n=56 Participants
Dapagliflozin 10mg + Metformin 1000mg
|
Glimepiride
n=56 Participants
Glimepiriide 1-2mg + Metformin 1000mg
|
|---|---|---|
|
Adjusted Mean Change in Subcutaneous Adipose Tissue (SAT) Area at Week 52
|
-5.41 cm^2
Interval -11.804 to 0.994
|
12.98 cm^2
Interval 6.462 to 19.506
|
SECONDARY outcome
Timeframe: From baseline to Week 52Adjusted Mean Change in Visceral to Subcutaneous Adipose Tissue Ratio at Week 52
Outcome measures
| Measure |
Dapagliflozin
n=56 Participants
Dapagliflozin 10mg + Metformin 1000mg
|
Glimepiride
n=56 Participants
Glimepiriide 1-2mg + Metformin 1000mg
|
|---|---|---|
|
Adjusted Mean Change in Visceral to Subcutaneous Adipose Tissue Ratio at Week 52
|
-0.05 ratio
Interval -0.115 to 0.017
|
-0.02 ratio
Interval -0.084 to 0.05
|
SECONDARY outcome
Timeframe: From baseline to Week 52Adjusted Mean Change in Lean Body Mass at Week 52
Outcome measures
| Measure |
Dapagliflozin
n=56 Participants
Dapagliflozin 10mg + Metformin 1000mg
|
Glimepiride
n=56 Participants
Glimepiriide 1-2mg + Metformin 1000mg
|
|---|---|---|
|
Adjusted Mean Change in Lean Body Mass at Week 52
|
-1.1 Kg
Interval -1.608 to -0.57
|
0.2 Kg
Interval -0.329 to 0.683
|
SECONDARY outcome
Timeframe: From baseline to Week 52Adjusted Mean Change in Adinopectin at Week 52
Outcome measures
| Measure |
Dapagliflozin
n=56 Participants
Dapagliflozin 10mg + Metformin 1000mg
|
Glimepiride
n=56 Participants
Glimepiriide 1-2mg + Metformin 1000mg
|
|---|---|---|
|
Adjusted Mean Change in Adinopectin at Week 52
|
1746.66 ng/mL
Interval 1296.144 to 2197.181
|
1088.95 ng/mL
Interval 638.431 to 1539.468
|
SECONDARY outcome
Timeframe: From baseline to Week 52Adjusted Mean Change in High Sensitivity C-Reactive Protein (hsCRP) at Week 52
Outcome measures
| Measure |
Dapagliflozin
n=56 Participants
Dapagliflozin 10mg + Metformin 1000mg
|
Glimepiride
n=56 Participants
Glimepiriide 1-2mg + Metformin 1000mg
|
|---|---|---|
|
Adjusted Mean Change in High Sensitivity C-Reactive Protein (hsCRP) at Week 52
|
-0.51 mg/L
Interval -1.03 to 0.014
|
-0.39 mg/L
Interval -0.914 to 0.131
|
Adverse Events
Dapagliflozin
Serious events: 6 serious events
Other events: 11 other events
Deaths: 0 deaths
Glimepiride
Serious events: 6 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dapagliflozin
n=60 participants at risk
Dapagliflozin 10mg + Metformin 1000mg
|
Glimepiride
n=61 participants at risk
Glimepiriide 1-2mg + Metformin 1000mg
|
|---|---|---|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/60 • 52 weeks
|
1.6%
1/61 • Number of events 1 • 52 weeks
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/60 • 52 weeks
|
1.6%
1/61 • Number of events 1 • 52 weeks
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/60 • 52 weeks
|
1.6%
1/61 • Number of events 1 • 52 weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.7%
1/60 • Number of events 1 • 52 weeks
|
0.00%
0/61 • 52 weeks
|
|
Injury, poisoning and procedural complications
Splenic injury
|
1.7%
1/60 • Number of events 1 • 52 weeks
|
0.00%
0/61 • 52 weeks
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
1.7%
1/60 • Number of events 1 • 52 weeks
|
0.00%
0/61 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.7%
1/60 • Number of events 1 • 52 weeks
|
0.00%
0/61 • 52 weeks
|
|
Nervous system disorders
Migraine
|
0.00%
0/60 • 52 weeks
|
1.6%
1/61 • Number of events 1 • 52 weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
1.7%
1/60 • Number of events 1 • 52 weeks
|
0.00%
0/61 • 52 weeks
|
|
Psychiatric disorders
Conversion disorder
|
1.7%
1/60 • Number of events 2 • 52 weeks
|
0.00%
0/61 • 52 weeks
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/60 • 52 weeks
|
1.6%
1/61 • Number of events 1 • 52 weeks
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
1.7%
1/60 • Number of events 1 • 52 weeks
|
0.00%
0/61 • 52 weeks
|
|
General disorders
Chest pain
|
0.00%
0/60 • 52 weeks
|
1.6%
1/61 • Number of events 1 • 52 weeks
|
Other adverse events
| Measure |
Dapagliflozin
n=60 participants at risk
Dapagliflozin 10mg + Metformin 1000mg
|
Glimepiride
n=61 participants at risk
Glimepiriide 1-2mg + Metformin 1000mg
|
|---|---|---|
|
Gastrointestinal disorders
Toothache
|
6.7%
4/60 • Number of events 5 • 52 weeks
|
1.6%
1/61 • Number of events 1 • 52 weeks
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
4/60 • Number of events 4 • 52 weeks
|
3.3%
2/61 • Number of events 2 • 52 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.0%
3/60 • Number of events 3 • 52 weeks
|
11.5%
7/61 • Number of events 12 • 52 weeks
|
Additional Information
EunYoung Kim / Local Study Specialist
Astrazeneca, Korea
Phone: 82 2 2188 0946
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee * The Institution and PI shall provide the Company with copies of any materials relating to the Study that either intends to publish (or submit for publication) or make any presentations relating to, at least 30 days in advance of publication * At the request of the Company, the Institution and PI shall withhold publication for a period of 90 days from the date on which the Company receives the material.
- Publication restrictions are in place
Restriction type: OTHER