Trial · NCT02564926
Foxiga Korea Local Phase 4 Study
NCT02564926, Phase 4, Completed, AstraZeneca; results first posted 2019-08-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Foxiga Korea Local Phase 4 Study. Trials, record NCT02564926. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02564926
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Foxiga Korea Local Phase 4 Study
- NCT number
- NCT02564926
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 125 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Dapagliflozin, Glimepiride
- First posted
- 2015-10-01
- Last updated
- 2019-08-20
- Results first posted
- 2019-08-20
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adjusted Mean Changes From Baseline in Total Body Fat Mass by DXA Scan | From baseline to Week 52 | Adjusted mean changes in total body fat mass from baseline using DXA scan in 52 weeks after the start of the treatment |
| Primary | Adjusted Mean Changes From Baseline in Percentage of Total Body Fat Assessed by DXA Scan | From baseline to Week 52 | Adjusted mean percent changes in total body fat mass from baseline using DXA scan in 52 weeks after the start of the treatment |
| Secondary | Adjusted Mean Change in HbA1c at Week 52 | From baseline to Week 52 | Adjusted Mean Change in HbA1c at Week 52 |
| Secondary | HbA1c <7.0% at Week 52 | 52 weeks | HbA1c \<7.0% at Week 52 |
| Secondary | Adjusted Mean Change in Fasting Blood Sugar (FBS) at Week 52 | From baseline to Week 52 | Adjusted Mean Change in Fasting Blood Sugar (FBS) at Week 52 |
| Secondary | Adjusted Mean Change in Total Body Weight at Week 52 | From baseline to Week 52 | Adjusted Mean Change in Total Body Weight at Week 52 |
| Secondary | Adjusted Mean Change in Waist Circumference at Week 52 | From baseline to Week 52 | Adjusted Mean Change in Waist Circumference at Week 52 |
| Secondary | Adjusted Mean Change in Body Mass Index (BMI) at Week 52 | From baseline to Week 52 | Adjusted Mean Change in Body Mass Index (BMI) at Week 52 |
| Secondary | Adjusted Mean Change in Systolic Blood Pressure (SBP) at Week 52 | From baseline to Week 52 | Adjusted Mean Change in Systolic Blood Pressure (SBP) at Week 52 |
| Secondary | Adjusted Mean Change in Diastolic Blood Pressure (DBP) at Week 52 | From baseline to Week 52 | Adjusted Mean Change in Diastolic Blood Pressure (DBP) at Week 52 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Adjusted Mean Changes From Baseline in Total Body Fat Mass by DXA Scan | From baseline to Week 52 | grams | LEAST_SQUARES_MEAN | |
| SECONDARY | Adjusted Mean Change in HbA1c at Week 52 | From baseline to Week 52 | percentages | LEAST_SQUARES_MEAN | |
| SECONDARY | HbA1c <7.0% at Week 52 | 52 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Adjusted Mean Change in Fasting Blood Sugar (FBS) at Week 52 | From baseline to Week 52 | mg/dL | LEAST_SQUARES_MEAN | |
| SECONDARY | Adjusted Mean Change in Total Body Weight at Week 52 | From baseline to Week 52 | kg | LEAST_SQUARES_MEAN | |
| SECONDARY | Adjusted Mean Change in Waist Circumference at Week 52 | From baseline to Week 52 | cm | LEAST_SQUARES_MEAN | |
| SECONDARY | Adjusted Mean Change in Body Mass Index (BMI) at Week 52 | From baseline to Week 52 | kg/m^2 | LEAST_SQUARES_MEAN | |
| SECONDARY | Adjusted Mean Change in Systolic Blood Pressure (SBP) at Week 52 | From baseline to Week 52 | mmHg | LEAST_SQUARES_MEAN | |
| SECONDARY | Adjusted Mean Change in Diastolic Blood Pressure (DBP) at Week 52 | From baseline to Week 52 | mmHg | LEAST_SQUARES_MEAN | |
| SECONDARY | Adjusted Mean Change in Visceral Adipose Tissue (VAT) Area at Week 52 | From baseline to Week 52 | cm^2 | LEAST_SQUARES_MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Adjusted Mean Changes From Baseline in Total Body Fat Mass by DXA Scan | Dapagliflozin | -1485.69 | 95% Confidence Interval -2025.543 to -945.844 | grams | |
| Adjusted Mean Changes From Baseline in Total Body Fat Mass by DXA Scan | Glimepiride | 1096.34 | 95% Confidence Interval 556.489 to 1636.187 | grams | |
| Adjusted Mean Change in HbA1c at Week 52 | Dapagliflozin | -1.00 | 95% Confidence Interval -1.259 to -0.745 | percentages | |
| Adjusted Mean Change in HbA1c at Week 52 | Glimepiride | -0.54 | 95% Confidence Interval -0.802 to -0.287 | percentages | |
| HbA1c <7.0% at Week 52 | Dapagliflozin | Count of participants that achieved the response | 27 | Participants | |
| HbA1c <7.0% at Week 52 | Glimepiride | Count of participants that achieved the response | 22 | Participants | |
| Adjusted Mean Change in Fasting Blood Sugar (FBS) at Week 52 | Dapagliflozin | -30.94 | 95% Confidence Interval -40.084 to -21.800 | mg/dL | |
| Adjusted Mean Change in Fasting Blood Sugar (FBS) at Week 52 | Glimepiride | -12.70 | 95% Confidence Interval -21.786 to -3.607 | mg/dL | |
| Adjusted Mean Change in Total Body Weight at Week 52 | Dapagliflozin | -2.4 | 95% Confidence Interval -3.104 to -1.664 | kg | |
| Adjusted Mean Change in Total Body Weight at Week 52 | Glimepiride | 1.3 | 95% Confidence Interval 0.545 to 1.984 | kg |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dapagliflozin | 60 | |
| Overall Study | STARTED | Glimepiride | 61 | |
| Overall Study | COMPLETED | Dapagliflozin | 52 | |
| Overall Study | COMPLETED | Glimepiride | 54 | |
| Overall Study | NOT COMPLETED | Dapagliflozin | 8 | |
| Overall Study | NOT COMPLETED | Glimepiride | 7 |
Source ClinicalTrials.gov
Adverse events32
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Toothache | Gastrointestinal disorders | Dapagliflozin | 4 | 60 | 5 |
| other | Toothache | Gastrointestinal disorders | Glimepiride | 1 | 61 | 1 |
| other | Nasopharyngitis | Infections and infestations | Dapagliflozin | 4 | 60 | 4 |
| other | Nasopharyngitis | Infections and infestations | Glimepiride | 2 | 61 | 2 |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Dapagliflozin | 3 | 60 | 3 |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Glimepiride | 7 | 61 | 12 |
| serious | Pyelonephritis acute | Infections and infestations | Dapagliflozin | 0 | 60 | 0 |
| serious | Pyelonephritis acute | Infections and infestations | Glimepiride | 1 | 61 | 1 |
| serious | Ankle fracture | Injury, poisoning and procedural complications | Dapagliflozin | 0 | 60 | 0 |
| serious | Ankle fracture | Injury, poisoning and procedural complications | Glimepiride | 1 | 61 | 1 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dapagliflozin | 0 | 60 |
| Total, all-cause mortality | Glimepiride | 0 | 61 |
| Total, other adverse events | Dapagliflozin | 11 | 60 |
| Total, other adverse events | Glimepiride | 10 | 61 |
| Total, serious adverse events | Dapagliflozin | 6 | 60 |
| Total, serious adverse events | Glimepiride | 6 | 61 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dapagliflozin vs Glimepiride: HbA1c <7.0% at Week 52 | Trial comparisons |
| Dapagliflozin vs Glimepiride: deaths from any cause | Trial comparisons |
| Dapagliflozin vs Glimepiride: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02564926
GET https://conductscience.org/api/trials/v1/NCT02564926/results?page=2