Clinical Trials List
Protocol NumberD1690C00018
NCT Number(ClinicalTrials.gov Identfier)NCT01031680
2010-03-01 - 2012-07-31
Phase III
Terminated9
ICD-10E08.8
Diabetes mellitus due to underlying condition with unspecified complications
ICD-10E09.8
Drug or chemical induced diabetes mellitus with unspecified complications
ICD-10E11.8
Type 2 diabetes mellitus with unspecified complications
ICD-10E13.8
Other specified diabetes mellitus with unspecified complications
ICD-9250.90
Diabetes with unspecified complication, Type II [non-insulin dependent type][NIDDM type][adult-onset type] or unspecified type, not stated as uncontrolled
A 24-week, multicentre, randomised, double-blind, age-stratified, placebo controlled phase III study with a 28-week extension period to evaluate the efficacy and safety of dapagliflozin 10 mg once daily in patients with type 2 diabetes, cardiovascular disease and hypertension, who exhibit inadequate glycaemic control on usual care
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Trial Applicant
-
Sponsor
AstraZeneca
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 傅家保 Division of Endocrinology
- 李文珍 Division of Endocrinology
- JUN-SING WANG Division of Endocrinology
- Wen Lieng LEE Division of Endocrinology
- 梁凱偉 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Wen-Cong Lu Division of Endocrinology
- 劉妙真 Division of Endocrinology
- 王誌慶 Division of Endocrinology
- Yu-Yao Huang Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 郭銘俊 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Ching-Chu Chen Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Kun Der Lin Division of Endocrinology
- Mei Yueh Lee Division of Endocrinology
- Pi-Jung Hsiao Division of Endocrinology
- 何俊緯 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 曾慶孝 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
type 2 diabetes
Objectives
Whether adding Dapagliflozin to the subjects' existing treatment drugs can reduce blood sugar, weight and blood pressure. If it is really effective, how does it compare to conventional treatment without Dapagliflozin? This trial will also collect and analyze safety data to determine the safety and tolerability of Dapagliflozin treatment for patients with diabetes, cardiovascular disease, and hypertension.
Test Drug
dapagliflozin
Active Ingredient
dapagliflozin
Dosage Form
tablet
Dosage
10
Endpoints
1. Main evaluation indicators:
Measure the average change between HbA1c and the basic value in the 24th week
After 24 weeks of treatment, measure the proportion of responders that fully meet the three indicators of clinical benefit, which is defined as:
-Compared with the basic value, the absolute decrease in HbA1c is 0.5% or more, and
-Compared with the basic value, the relative decrease in total body weight is 3% or more, and
-Compared with the basic value, the absolute drop in systolic blood pressure measured while sitting is 3 mmHg or more,
2. Secondary evaluation indicators:
At the 8th week of the measurement, the average change between the systolic blood pressure measured while sitting and the basic value
At the 24th week of the measurement, the average amount of change between the weight percentage and the basic value
At the 24th week of the measurement, the average change between the systolic blood pressure measured while sitting and the basic value
For patients with BMI ≥27 kg/m2, measure the proportion of patients whose body weight at week 24 has decreased by 5% or more from the basic value
Other secondary evaluation indicators:
At the 24th week of the measurement, the average change between the diastolic blood pressure and the basic value
For patients who originally sat and measured systolic blood pressure ≥130 mmHg, at week 24, the proportion of patients who sat and measured systolic blood pressure <130 mmHg
The change between the average weight and the basic value at the 24th week of the measurement
For patients with original HbA1c ≥ 8.0% and HbA1c ≥ 9.0%, measure the average change between HbA1c and the basic value at week 24
At the 24th week of the measurement, the proportion of patients who had a blood glucose response to treatment (defined as HbA1c <7.0%)
Measure the fasting blood glucose (FPG) in the first week and the 24th week, and the average change from the basic value
At 4th, 8th, 16th and 24th weeks, under the pre-specified rescue conditions, the proportion of patients who failed the treatment for maintaining FPG
At 8, 16, and 24 weeks, under the pre-specified rescue conditions, the proportion of patients who failed treatment to maintain blood pressure (systolic and diastolic blood pressure)
At week 24, the proportion of patients who achieved a treatment response (defined as a decrease in HbA1c by 0.5% or more)
At the 24th week, the systolic blood pressure measured while sitting decreased by 3 mmHg or more, and the proportion of patients decreased by 5 mmHg or more
At week 24, the average percentage change of fasting blood lipids (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides and free fatty acids) from the basic value
For patients who were originally treated with insulin, in week 24, the average amount of change between the calculated value of the average daily insulin consumption and the basic value
In week 24, use EuroQol-5D (EQ-5D) questionnaire to evaluate the average change between health-related quality of life and basic values
3. Safety assessment indicators:
Side effects, laboratory data, electrocardiogram, pulse, blood pressure, side effects of hypoglycemia, cardiovascular side effects, calculated value of creatinine clearance rate, estimated value of glomerular filtration rate, findings of physical examination.
Measure the average change between HbA1c and the basic value in the 24th week
After 24 weeks of treatment, measure the proportion of responders that fully meet the three indicators of clinical benefit, which is defined as:
-Compared with the basic value, the absolute decrease in HbA1c is 0.5% or more, and
-Compared with the basic value, the relative decrease in total body weight is 3% or more, and
-Compared with the basic value, the absolute drop in systolic blood pressure measured while sitting is 3 mmHg or more,
2. Secondary evaluation indicators:
At the 8th week of the measurement, the average change between the systolic blood pressure measured while sitting and the basic value
At the 24th week of the measurement, the average amount of change between the weight percentage and the basic value
At the 24th week of the measurement, the average change between the systolic blood pressure measured while sitting and the basic value
For patients with BMI ≥27 kg/m2, measure the proportion of patients whose body weight at week 24 has decreased by 5% or more from the basic value
Other secondary evaluation indicators:
At the 24th week of the measurement, the average change between the diastolic blood pressure and the basic value
For patients who originally sat and measured systolic blood pressure ≥130 mmHg, at week 24, the proportion of patients who sat and measured systolic blood pressure <130 mmHg
The change between the average weight and the basic value at the 24th week of the measurement
For patients with original HbA1c ≥ 8.0% and HbA1c ≥ 9.0%, measure the average change between HbA1c and the basic value at week 24
At the 24th week of the measurement, the proportion of patients who had a blood glucose response to treatment (defined as HbA1c <7.0%)
Measure the fasting blood glucose (FPG) in the first week and the 24th week, and the average change from the basic value
At 4th, 8th, 16th and 24th weeks, under the pre-specified rescue conditions, the proportion of patients who failed the treatment for maintaining FPG
At 8, 16, and 24 weeks, under the pre-specified rescue conditions, the proportion of patients who failed treatment to maintain blood pressure (systolic and diastolic blood pressure)
At week 24, the proportion of patients who achieved a treatment response (defined as a decrease in HbA1c by 0.5% or more)
At the 24th week, the systolic blood pressure measured while sitting decreased by 3 mmHg or more, and the proportion of patients decreased by 5 mmHg or more
At week 24, the average percentage change of fasting blood lipids (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides and free fatty acids) from the basic value
For patients who were originally treated with insulin, in week 24, the average amount of change between the calculated value of the average daily insulin consumption and the basic value
In week 24, use EuroQol-5D (EQ-5D) questionnaire to evaluate the average change between health-related quality of life and basic values
3. Safety assessment indicators:
Side effects, laboratory data, electrocardiogram, pulse, blood pressure, side effects of hypoglycemia, cardiovascular side effects, calculated value of creatinine clearance rate, estimated value of glomerular filtration rate, findings of physical examination.
Inclution Criteria
1) Sign the subject's consent form before starting any test procedure
2) Patients who have been diagnosed with type 2 diabetes
3) Age at the time of inclusion in the visit:
-Males over 45 years old
-Female over 50 years old
4) Before being included in the visit, the hypoglycemic drugs that have been used daily for 8 weeks and the dose has been stable for at least 4 weeks, and meet any of the following conditions:
-Using single or compound oral hypoglycemic drug treatments, such as GLUCOPHAGE/metformin, ACTOS/pioglitazone, sulfonylurea, GLUCOBAY/acarbose or dipeptidyl Peptide 4 (DPP-4) inhibitors (ONGLYZA/saxagliptin), JANUVIA/sitagliptin, (Galvus/vildagliptin), but do not use AVANDIA/rosiglitazone for at least 8 weeks before inclusion.
-Insulin combined with oral hypoglycemic drugs for treatment
-Insulin monotherapy
5) When included in the interview, glycosylated hemoglobin (glycated hemoglobin) is greater than or equal to 7.2%, and less than or equal to 10.5% (the value measured on the blood sample collected in the screening visit)
6) Cardiovascular disease, defined as:
-Previous history of coronary heart disease
-History of myocardial infarction, or
-Vascular reconstruction, or a history of coronary artery stenosis more than 50% confirmed by angiography, or
-Abnormal images of stress test, consistent with history of ischemia or myocardial infarction
-A history of stroke or transient cerebral ischemia (TIA), or
-Peripheral arterial disease (PAD), and the use of revascularization therapy (not receiving resection therapy) medical history
7) Hypertension is defined as follows:
-Be diagnosed with essential hypertension before screening, or
-Use two or more antihypertensive drugs (diuretics, beta blockers, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, calcium channel antagonists) treatment, and start The purpose of using one of them is to lower blood pressure, or
-Have used an antihypertensive drug, and in the past doctors have recorded blood pressure exceeding 130/80 millimeters of mercury (mmHg).
8) Those who are receiving blood pressure lowering treatment must have continued to use blood pressure lowering drugs for at least 4 weeks before being included in the visit.
9) Female subjects:
Women who are not fertile; or who are fertile but comply with the following regulations:
-Use highly effective contraceptive methods to avoid pregnancy during the trial period and within 4 weeks after the trial.
-Within 72 hours before starting to take the test drug, and at each visit, the pregnancy test result is negative (the minimum sensitivity of human chorionic gonadotropin (HCG) testing is 25 International Units/L (IU/L) or its equivalent unit).
Random allocation (the 4th visit, based on the blood test value of the 3rd visit) inclusion conditions:
In the case of random allocation, the inclusion conditions of items 1 to 9 above and the following inclusion conditions should be met:
10) Glycated hemoglobin is greater than or equal to 7.0% and less than or equal to 10.0% (the blood test value of the third visit).
11) Prior to random assignment, the patients have been continuously treated with single or compound oral hypoglycemic drugs (with or without insulin) for at least 12 weeks.
12) Before random assignment, if insulin is injected, it must be used for at least 12 weeks.
13) Before random allocation, the doses of hypoglycemic drugs and insulin formulations must be stable for at least 8 weeks.
14) Before random assignment, those who are currently using antihypertensive drugs must have been using antihypertensive drugs for 8 weeks, and the dosage must be stable for 4 weeks.
15) Before random assignment, if there are people using hypolipidemic drugs and/or antiplatelet therapy, they must have been using them for 4 weeks.
2) Patients who have been diagnosed with type 2 diabetes
3) Age at the time of inclusion in the visit:
-Males over 45 years old
-Female over 50 years old
4) Before being included in the visit, the hypoglycemic drugs that have been used daily for 8 weeks and the dose has been stable for at least 4 weeks, and meet any of the following conditions:
-Using single or compound oral hypoglycemic drug treatments, such as GLUCOPHAGE/metformin, ACTOS/pioglitazone, sulfonylurea, GLUCOBAY/acarbose or dipeptidyl Peptide 4 (DPP-4) inhibitors (ONGLYZA/saxagliptin), JANUVIA/sitagliptin, (Galvus/vildagliptin), but do not use AVANDIA/rosiglitazone for at least 8 weeks before inclusion.
-Insulin combined with oral hypoglycemic drugs for treatment
-Insulin monotherapy
5) When included in the interview, glycosylated hemoglobin (glycated hemoglobin) is greater than or equal to 7.2%, and less than or equal to 10.5% (the value measured on the blood sample collected in the screening visit)
6) Cardiovascular disease, defined as:
-Previous history of coronary heart disease
-History of myocardial infarction, or
-Vascular reconstruction, or a history of coronary artery stenosis more than 50% confirmed by angiography, or
-Abnormal images of stress test, consistent with history of ischemia or myocardial infarction
-A history of stroke or transient cerebral ischemia (TIA), or
-Peripheral arterial disease (PAD), and the use of revascularization therapy (not receiving resection therapy) medical history
7) Hypertension is defined as follows:
-Be diagnosed with essential hypertension before screening, or
-Use two or more antihypertensive drugs (diuretics, beta blockers, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, calcium channel antagonists) treatment, and start The purpose of using one of them is to lower blood pressure, or
-Have used an antihypertensive drug, and in the past doctors have recorded blood pressure exceeding 130/80 millimeters of mercury (mmHg).
8) Those who are receiving blood pressure lowering treatment must have continued to use blood pressure lowering drugs for at least 4 weeks before being included in the visit.
9) Female subjects:
Women who are not fertile; or who are fertile but comply with the following regulations:
-Use highly effective contraceptive methods to avoid pregnancy during the trial period and within 4 weeks after the trial.
-Within 72 hours before starting to take the test drug, and at each visit, the pregnancy test result is negative (the minimum sensitivity of human chorionic gonadotropin (HCG) testing is 25 International Units/L (IU/L) or its equivalent unit).
Random allocation (the 4th visit, based on the blood test value of the 3rd visit) inclusion conditions:
In the case of random allocation, the inclusion conditions of items 1 to 9 above and the following inclusion conditions should be met:
10) Glycated hemoglobin is greater than or equal to 7.0% and less than or equal to 10.0% (the blood test value of the third visit).
11) Prior to random assignment, the patients have been continuously treated with single or compound oral hypoglycemic drugs (with or without insulin) for at least 12 weeks.
12) Before random assignment, if insulin is injected, it must be used for at least 12 weeks.
13) Before random allocation, the doses of hypoglycemic drugs and insulin formulations must be stable for at least 8 weeks.
14) Before random assignment, those who are currently using antihypertensive drugs must have been using antihypertensive drugs for 8 weeks, and the dosage must be stable for 4 weeks.
15) Before random assignment, if there are people using hypolipidemic drugs and/or antiplatelet therapy, they must have been using them for 4 weeks.
Exclusion Criteria
Endocrine and metabolic disorders
1) Diagnosed as Type 1 Diabetes, Young Adult Diabetes (MODY) or Secondary Diabetes
2) Use 3 or more oral hypoglycemic drugs (regardless of whether they are combined with insulin)
3) History of ketoacidosis
4) Within 3 months before the enrollment visit, there are symptoms of poor diabetes control, including (but not limited to these symptoms): obvious polyuria, thirst, and/or weight loss of more than 10%
5) At the time of random assignment, fasting blood glucose (FPG) is greater than 270 mg/dl (blood samples will be collected at the 3rd visit)
6) History of bariatric surgery (any surgery to treat obesity, such as gastric band, or procedures related to bypass surgery, or replacement of part of the small intestine). However, those with a history of liposuction are allowed.
7) Diabetes insipidus
8) Thyroid hormone (TSH) and free thyroxine (T4) values exceed the normal range, and those with abnormal thyroid hormones must undergo a free thyroxine follow-up test. Those with abnormal free thyroxine values will be ruled out
Cardiovascular diseases
9) Recent cardiovascular events:
-Acute Coronary Syndrome (ACS) occurred within 2 months before the enrollment visit
-Hospitalized due to unstable angina or acute myocardial infarction within 2 months before the enrollment
-Acute stroke or transient cerebral ischemic attack occurred within 2 months before the enrollment visit
-In the past two months, underwent coronary artery revascularization surgery
10) Grade 4 congestive heart failure, unstable or acute congestive heart failure defined by the New York Heart Association (NYHA). For patients with congestive heart failure who can join this trial, especially those who are receiving diuretic therapy, their volume status should be carefully monitored during the entire trial.
11) Blood pressure:
-Inclusion (first visit):
The systolic blood pressure is greater than or equal to 165 mmHg and/or the diastolic blood pressure is greater than or equal to 100 mmHg
-Random assignment (visit 4):
The systolic blood pressure is greater than or equal to 160 mmHg and/or the diastolic blood pressure is greater than or equal to 100 mmHg
Kidney disease
12) The calculated value of creatinine clearance rate is less than 60 ml/min (mL/min)
13) Urine albumin: Creatinine ratio (UACR) is greater than 1800 mg/g (mg/g)
14) History of unstable or rapidly deteriorating kidney disease
15) Familial renal diabetes. Those without a diagnosis of diabetes are diagnosed as diabetes (greater than 1.0 millimoles/liter of urine (mmol/L)) when blood sugar is normal
Liver Disease
16) Severe liver dysfunction and/or significant liver dysfunction, defined as aspartate transaminase (AST) greater than 3 times the upper limit of normal and/or alanine transaminase (ALT) greater than 3 times the upper limit of normal
17) Total bilirubin is greater than 2.0 mg/dL (34.2 μmol/L)
18) The current infectious liver disease has positive serum evidence, including: hepatitis B virus antibody IGM, hepatitis B surface antigen and hepatitis C virus antibody, with positive serum evidence
19) Medical history of elevated liver enzymes
20) Any history of severe hepatobiliary disease or drug-associated hepatotoxicity
Disease/state of blood/tumor
21) Male: hemoglobin is less than 10 g/dL (less than 100 g/L) or 6.2 mmol/L; female: hemoglobin is less than 9.0 g/dL (<90 g/L) or 5.9 mmol/L
22) Chronic hemolytic anemia or hemoglobin disease (for example: sickle cell anemia, thalassemia, iron blastic anemia). Slight hemolysis caused by the characteristics of artificial heart valves or sickle cells is not an exclusion condition unless the hemoglobin concentration is too low (the same as the hemoglobin condition defined above)
23) Donated or transfused whole blood, plasma or platelets within 3 months before the first visit
24) A history of malignant tumors within 5 years, excluding successfully treated basal or squamous cell skin cancers
Infectious diseases/immune disorders
25) Known immune function deficits, including patients who have received organ transplants
Skeletal muscle abnormalities
26) Creatine kinase (CK) is greater than 3 times the upper limit of normal
27) History of drug-induced myotoxicity or drug-induced increase in creatine kinase
Fertility status
28) Pregnant or breastfeeding
Banned drugs
29) Have used AVANDIA/Rosiglitazone within 12 weeks before random assignment
30) In the 30 days before inclusion, use weight-loss drugs, including but not limited to: Nuomet (REDUCTIL/sibutramine), Fastin (phentermine), Roche fresh (XENICAL/orlistat), Acomplia (Rimonabant), Didrex (benzphetamine), Tenuate (Diethylpropion), methamphetamine, phendimetrazine
31) In the 30 days before inclusion, use corticosteroids equivalent to daily oral prednisolone greater than or equal to 10 mg (betamethasone greater than or equal to 1.2 mg, dexamethasone greater than or equal to 1.5 mg, hydrocortisone greater than or equal to 40 mg). However, topical or inhaled corticosteroids are allowed.
32) Use unstable doses of FORTEO/teriparatide, bisphosphonates, and calcitonin treatment. Note: In the 30 days before inclusion, if the dosage of bone stability, bisphosphonates, and calcitonin remains unchanged, they can participate in this trial.
33) Treat human immunodeficiency virus (HIV) and/or use the antiviral drugs Rescriptor (delavirdine), CRIXIVAN/indinavir, VIRACEPT/nelfinavir, KALETRA/ritonavir, and TOMI (FORTOVASE /saquinavir)
Other standard conditions
34) Those who have intolerance, contraindications, or may have allergic or sensitive reactions to dapagliflozin, placebo or excipient formulations
35) Any clinically significant abnormalities found in physical examinations, electrocardiograms, and laboratory tests will endanger your safety and successful participation during the trial according to the trial physician's judgment.
36) According to the trial physician's judgment, there may be a risk of dehydration
37) Acute or chronic metabolic acidosis
38) Medical history of alcohol abuse or illegal drug use in the past 12 months
39) Participate in the planning and execution of trials (applicable to employees of Taiwan AstraZeneca Co., Ltd. and Taiwan Bristol-Myers Squibb Co., Ltd. or test center personnel)
40) Have previously participated in the enrollment or random assignment visits of this trial
41) Have previously participated in a clinical trial of dapagliflozin (BMS-512148) and/or any other sodium-glucose co-transporter 2 (SGLT2) inhibitor, and received at least one dose of the trial drug during the trial period
42) Participate in other clinical trials within the last month
43) In the 4 weeks before random assignment, have any clinically significant disease symptoms, including influenza diseases such as avian influenza or type A H1N1 influenza that may be diagnosed
44) Suspected infection of World Health Organization (WHO) risk level 2~4
1) Diagnosed as Type 1 Diabetes, Young Adult Diabetes (MODY) or Secondary Diabetes
2) Use 3 or more oral hypoglycemic drugs (regardless of whether they are combined with insulin)
3) History of ketoacidosis
4) Within 3 months before the enrollment visit, there are symptoms of poor diabetes control, including (but not limited to these symptoms): obvious polyuria, thirst, and/or weight loss of more than 10%
5) At the time of random assignment, fasting blood glucose (FPG) is greater than 270 mg/dl (blood samples will be collected at the 3rd visit)
6) History of bariatric surgery (any surgery to treat obesity, such as gastric band, or procedures related to bypass surgery, or replacement of part of the small intestine). However, those with a history of liposuction are allowed.
7) Diabetes insipidus
8) Thyroid hormone (TSH) and free thyroxine (T4) values exceed the normal range, and those with abnormal thyroid hormones must undergo a free thyroxine follow-up test. Those with abnormal free thyroxine values will be ruled out
Cardiovascular diseases
9) Recent cardiovascular events:
-Acute Coronary Syndrome (ACS) occurred within 2 months before the enrollment visit
-Hospitalized due to unstable angina or acute myocardial infarction within 2 months before the enrollment
-Acute stroke or transient cerebral ischemic attack occurred within 2 months before the enrollment visit
-In the past two months, underwent coronary artery revascularization surgery
10) Grade 4 congestive heart failure, unstable or acute congestive heart failure defined by the New York Heart Association (NYHA). For patients with congestive heart failure who can join this trial, especially those who are receiving diuretic therapy, their volume status should be carefully monitored during the entire trial.
11) Blood pressure:
-Inclusion (first visit):
The systolic blood pressure is greater than or equal to 165 mmHg and/or the diastolic blood pressure is greater than or equal to 100 mmHg
-Random assignment (visit 4):
The systolic blood pressure is greater than or equal to 160 mmHg and/or the diastolic blood pressure is greater than or equal to 100 mmHg
Kidney disease
12) The calculated value of creatinine clearance rate is less than 60 ml/min (mL/min)
13) Urine albumin: Creatinine ratio (UACR) is greater than 1800 mg/g (mg/g)
14) History of unstable or rapidly deteriorating kidney disease
15) Familial renal diabetes. Those without a diagnosis of diabetes are diagnosed as diabetes (greater than 1.0 millimoles/liter of urine (mmol/L)) when blood sugar is normal
Liver Disease
16) Severe liver dysfunction and/or significant liver dysfunction, defined as aspartate transaminase (AST) greater than 3 times the upper limit of normal and/or alanine transaminase (ALT) greater than 3 times the upper limit of normal
17) Total bilirubin is greater than 2.0 mg/dL (34.2 μmol/L)
18) The current infectious liver disease has positive serum evidence, including: hepatitis B virus antibody IGM, hepatitis B surface antigen and hepatitis C virus antibody, with positive serum evidence
19) Medical history of elevated liver enzymes
20) Any history of severe hepatobiliary disease or drug-associated hepatotoxicity
Disease/state of blood/tumor
21) Male: hemoglobin is less than 10 g/dL (less than 100 g/L) or 6.2 mmol/L; female: hemoglobin is less than 9.0 g/dL (<90 g/L) or 5.9 mmol/L
22) Chronic hemolytic anemia or hemoglobin disease (for example: sickle cell anemia, thalassemia, iron blastic anemia). Slight hemolysis caused by the characteristics of artificial heart valves or sickle cells is not an exclusion condition unless the hemoglobin concentration is too low (the same as the hemoglobin condition defined above)
23) Donated or transfused whole blood, plasma or platelets within 3 months before the first visit
24) A history of malignant tumors within 5 years, excluding successfully treated basal or squamous cell skin cancers
Infectious diseases/immune disorders
25) Known immune function deficits, including patients who have received organ transplants
Skeletal muscle abnormalities
26) Creatine kinase (CK) is greater than 3 times the upper limit of normal
27) History of drug-induced myotoxicity or drug-induced increase in creatine kinase
Fertility status
28) Pregnant or breastfeeding
Banned drugs
29) Have used AVANDIA/Rosiglitazone within 12 weeks before random assignment
30) In the 30 days before inclusion, use weight-loss drugs, including but not limited to: Nuomet (REDUCTIL/sibutramine), Fastin (phentermine), Roche fresh (XENICAL/orlistat), Acomplia (Rimonabant), Didrex (benzphetamine), Tenuate (Diethylpropion), methamphetamine, phendimetrazine
31) In the 30 days before inclusion, use corticosteroids equivalent to daily oral prednisolone greater than or equal to 10 mg (betamethasone greater than or equal to 1.2 mg, dexamethasone greater than or equal to 1.5 mg, hydrocortisone greater than or equal to 40 mg). However, topical or inhaled corticosteroids are allowed.
32) Use unstable doses of FORTEO/teriparatide, bisphosphonates, and calcitonin treatment. Note: In the 30 days before inclusion, if the dosage of bone stability, bisphosphonates, and calcitonin remains unchanged, they can participate in this trial.
33) Treat human immunodeficiency virus (HIV) and/or use the antiviral drugs Rescriptor (delavirdine), CRIXIVAN/indinavir, VIRACEPT/nelfinavir, KALETRA/ritonavir, and TOMI (FORTOVASE /saquinavir)
Other standard conditions
34) Those who have intolerance, contraindications, or may have allergic or sensitive reactions to dapagliflozin, placebo or excipient formulations
35) Any clinically significant abnormalities found in physical examinations, electrocardiograms, and laboratory tests will endanger your safety and successful participation during the trial according to the trial physician's judgment.
36) According to the trial physician's judgment, there may be a risk of dehydration
37) Acute or chronic metabolic acidosis
38) Medical history of alcohol abuse or illegal drug use in the past 12 months
39) Participate in the planning and execution of trials (applicable to employees of Taiwan AstraZeneca Co., Ltd. and Taiwan Bristol-Myers Squibb Co., Ltd. or test center personnel)
40) Have previously participated in the enrollment or random assignment visits of this trial
41) Have previously participated in a clinical trial of dapagliflozin (BMS-512148) and/or any other sodium-glucose co-transporter 2 (SGLT2) inhibitor, and received at least one dose of the trial drug during the trial period
42) Participate in other clinical trials within the last month
43) In the 4 weeks before random assignment, have any clinically significant disease symptoms, including influenza diseases such as avian influenza or type A H1N1 influenza that may be diagnosed
44) Suspected infection of World Health Organization (WHO) risk level 2~4
The Estimated Number of Participants
-
Taiwan
125 participants
-
Global
2350 participants
