Clinical Trials List
Protocol NumberD1690C00007
NCT Number(ClinicalTrials.gov Identfier)N/A
2009-01-01 - 2010-06-30
Phase III
Terminated8
ICD-10E11.9
Type 2 diabetes mellitus without complications
ICD-10E13.9
Other specified diabetes mellitus without complications
ICD-9250.00
Diabetes mellitus without mention of complication, Type II [non-insulin dependent type][NIDDM type] [ adult-onset type] or unspecified type, not stated as uncontrolled
Evaluation Dapagliflozin inhibitor and with Metformin and controls DPP-4 (Sitagliptin) and received unilateral Metformin Metformin therapy with poor glycemic control in diabetic adult still disease international efficacy and safety of 24 weeks after a second type, multi-center, Random assignment, parallel, double-blind, curative effect control group, phase III clinical trial.
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Trial Applicant
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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
- Yu-Yao Huang Division of Endocrinology
- Shu-Fu Lin Shu-Fu Lin Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 林時逸 Division of Endocrinology
- JUN-SING WANG Division of Endocrinology
- 李文珍 Division of Endocrinology
- I-TE LEE Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Chii-Min Hwu Division of Endocrinology
- Harn-Shen Chen Division of Endocrinology
- Ching Fai Kwok Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 陳偉哲 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 張毓泓 Division of Endocrinology
- Pi-Jung Hsiao Division of Endocrinology
- Kun Der Lin Division of Endocrinology
- Mei Yueh Lee Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- - - Division of Endocrinology
- CHIH-YUAN WANG CHIH-YUAN WANG Division of Endocrinology
- CHIH-YUAN WANG Division of Endocrinology
- 李弘元 Division of Endocrinology
- 張恬君 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 陳偉哲 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Patients with type 2 diabetes who still have poor blood sugar control after taking at least 1,500 mg of Metformin daily
Objectives
The main purpose of this trial is to study the type 2 diabetes patients whose blood sugar is still poorly controlled after taking at least 1,500 mg of Metformin daily. After 24 weeks of double-blind oral treatment, Dapagliflozin 10 mg combined with Metformin treatment group HbA1c) Whether the change from the baseline value is not inferior to the Sitagliptin 100 mg and Metformin treatment group.
Test Drug
Dapagliflozin/placebo; Sitagliptin/placebo
Active Ingredient
Dapagliflozin/placebo
Sitagliptin/placebo
Sitagliptin/placebo
Dosage Form
capsule
tablet
tablet
Dosage
10
100
100
Endpoints
The main purpose of this trial is to study the type 2 diabetes patients whose blood sugar is still poorly controlled after taking at least 1,500 mg of Metformin daily. After 24 weeks of double-blind oral treatment, Dapagliflozin 10 mg combined with Metformin treatment group HbA1c) Whether the change from the baseline value is not inferior to the Sitagliptin 100 mg and Metformin treatment group.
Inclution Criteria
Main inclusion conditions: inclusion conditions at the time of inclusion (1st) visit
1. Sign this consent form before the start of any trial specific procedures.
2. At the time of signing the consent form, they must be over 18 years old and under 79 years old.
3. Diagnosed with type 2 diabetes.
4. Inappropriate blood sugar control is defined as: glycosylated hemoglobin (HbA1c) greater than 7% and less than or equal to 10.5%.
5. Currently receiving Metformin monotherapy, and have been taking a stable dose of Metformin greater than or equal to 1,500 milligrams (mg) per day for at least 8 weeks before being included in the trial.
6. Women with fertility need to follow the following instructions: l During the entire trial period and within 4 weeks after the trial, appropriate contraceptive measures must be taken to prevent pregnancy. Only by doing so can the risk of pregnancy be minimized. l The serum or urine pregnancy test must be negative within 72 hours before starting to use the test drug. Women with fertility include: – Anyone who has menstrual cramps, has not undergone successful ligation (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or has not yet menopause (defined as: no menstruation for more than 12 months) ) Of women. – Women who are receiving hormone replacement therapy and have records showing that the serum follicle stimulating hormone is greater than 35 million units/ml (mIU/ml). – Currently using oral, implanted, or injected hormonal contraceptives or device contraceptive products, such as intrauterine contraceptives or barrier methods (uterine caps, condoms, spermicides) for contraception, or practice abstinence or a partner Ligation (vasectomy) should be for women who are likely to become pregnant. Inclusion conditions for the placebo lead-in period (visit 2 based on the inspection data of the first visit)
7. Have received a minimum daily dose of 1,500 mg and a maximum of 2,500 mg of Metformin daily for at least 8 weeks.
8. Glycated hemoglobin is greater than 7% and less than or equal to 10.5%
9. Fasting blood glucose level (FPG) is less than or equal to 270 milligrams per deciliter (mg/dL) (less than or equal to 15 millimoles/liter (mmol/L)) Inclusion conditions for random assignment (visit 3, based on the inspection data of the second visit)
10. Hemoglobin A1c is greater than 7% and less than or equal to 10.5%
11. Fasting blood glucose is less than or equal to 270 mg/dL
1. Sign this consent form before the start of any trial specific procedures.
2. At the time of signing the consent form, they must be over 18 years old and under 79 years old.
3. Diagnosed with type 2 diabetes.
4. Inappropriate blood sugar control is defined as: glycosylated hemoglobin (HbA1c) greater than 7% and less than or equal to 10.5%.
5. Currently receiving Metformin monotherapy, and have been taking a stable dose of Metformin greater than or equal to 1,500 milligrams (mg) per day for at least 8 weeks before being included in the trial.
6. Women with fertility need to follow the following instructions: l During the entire trial period and within 4 weeks after the trial, appropriate contraceptive measures must be taken to prevent pregnancy. Only by doing so can the risk of pregnancy be minimized. l The serum or urine pregnancy test must be negative within 72 hours before starting to use the test drug. Women with fertility include: – Anyone who has menstrual cramps, has not undergone successful ligation (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or has not yet menopause (defined as: no menstruation for more than 12 months) ) Of women. – Women who are receiving hormone replacement therapy and have records showing that the serum follicle stimulating hormone is greater than 35 million units/ml (mIU/ml). – Currently using oral, implanted, or injected hormonal contraceptives or device contraceptive products, such as intrauterine contraceptives or barrier methods (uterine caps, condoms, spermicides) for contraception, or practice abstinence or a partner Ligation (vasectomy) should be for women who are likely to become pregnant. Inclusion conditions for the placebo lead-in period (visit 2 based on the inspection data of the first visit)
7. Have received a minimum daily dose of 1,500 mg and a maximum of 2,500 mg of Metformin daily for at least 8 weeks.
8. Glycated hemoglobin is greater than 7% and less than or equal to 10.5%
9. Fasting blood glucose level (FPG) is less than or equal to 270 milligrams per deciliter (mg/dL) (less than or equal to 15 millimoles/liter (mmol/L)) Inclusion conditions for random assignment (visit 3, based on the inspection data of the second visit)
10. Hemoglobin A1c is greater than 7% and less than or equal to 10.5%
11. Fasting blood glucose is less than or equal to 270 mg/dL
Exclusion Criteria
Exclusion conditions when included in the (1st) visit:
1. Diagnosed as type 1 diabetes, young type diabetes or secondary diabetes.
2. Received insulin therapy within 24 weeks before being included in the trial (except for use during hospitalization or during pregnancy in patients with gestational diabetes).
3. History of diabetes insipidus.
4. History of diabetic ketoacidosis or other acute or chronic metabolic acidosis.
5. Symptoms of poor diabetes control, including but not limited to the following symptoms: significant polyuria, polydipsia, and/or weight loss of more than 10% within 3 months before being included in the trial.
6. Have received Sitagliptin (DPP-4 inhibitor) treatment before.
7. The body mass index is greater than 45 kg/meter square.
8. History of unstable or rapidly progressing kidney disease.
9. Known congenital renal diabetes.
10. Severe liver and gallbladder disease or history of liver toxicity caused by any drug.
11. Currently pregnant and breastfeeding.
12. Within 30 days before being included in the trial, were receiving glucocorticoids at a dose equivalent to daily oral: Prednisolone greater than 10 mg, Betamethasone greater than 1.2 mg, Dexamethasone greater than 1.5 mg, or greater than 40 Milligrams of Hydrocortisone; but inhaled and smeared corticosteroids (corticosteroids) can be used.
13. Have undergone bariatric surgery.
14. Take weight-loss drugs within 30 days before being included in the trial, including but not limited to the following drugs: Sibutramine, Phentermine, Orlistat, Rimonabant, Benzphetamine, Diethylpropion, Methaphetamine and/or Phendimetrazine.
15. Use antiviral drugs: Delavirdine, Indinavir, Ritonavir, Saquinavir to treat human immunodeficiency virus (HIV), and/or conditions known to have immune insufficiency, including having received an organ transplant.
16. Congestive heart failure, defined as: New York Heart Association (NYHA) grade 3 or 4, unstable congestive heart failure and/or left ventricular ejection fraction (LVEF) less than or equal to 40%.
17. A history of major cardiovascular disease within 6 months before the screening visit, defined as: myocardial infarction, unstable angina, transient ischemic attack, unstable or undiagnosed arrhythmia, cardiac surgery, or vascular reconstruction Surgery (coronary artery repair or bypass graft) or cerebrovascular accident.
18. Severe respiratory failure or emphysema.
19. The systolic blood pressure is greater than or equal to 180 millimeters of mercury (mmHg) and/or the diastolic blood pressure is greater than or equal to 110 millimeters of mercury.
20. Any abnormality of clinical significance found in physical examination, electrocardiogram or laboratory test, and determined by the trial physician may affect the safety of the patient during the trial or the successful participation in this trial.
21. Use Teriparatid, Bisphosphonates and/or Calcitonin at unstable doses (Note: If the dose of Teriparatid, Bisphosphonates and/or Calcitonin remains unchanged within 30 days before being included in the trial, you can enter this trial.).
22. According to the doctor, there may be a risk of dehydration.
23. Suffer from chronic hemolytic anemia or hemoglobin disease (sickle cell anemia or thalassemia, sideroblastic anemia).
24. A medical history of drugs causing liver enzymes to rise.
25. A medical history of drug-induced muscle disease or drug-induced increase in creatine kinase (CK).
26. Acute or chronic metabolic acidosis.
27. Malignant tumors in the past 5 years, except for basal cell or squamous cell skin cancers that have been successfully treated. 28. Have a history of alcohol or illegal drug addiction in the past 12 months.
29. To Dapagliflozin, Metformin, Sitagliptin, Glimepiride, other Sulfonylurea, placebo or formulation excipients intolerance, contraindications or possible allergic reactions.
30. According to the trial physician's judgment, suspected or determined to have poor compliance with the plan's regulations and medication.
31. People who have donated or transfused blood, plasma or platelets within 3 months before the first visit.
32. Participate in the plans and implementation of this trial (applicable to employees of Taiwan Astertec Co., Ltd. and Taiwan Bristol-Myers Squibb Co., Ltd. or test center personnel).
33. Those who have been previously enrolled or randomly assigned to enter this trial to receive treatment.
34. Have previously participated in clinical trials of Dapagliflozin (BMS-512148) and/or any other glucose transporter 2 (SGLT2) inhibitors.
35. Participated in other clinical trials in the past month. The exclusion conditions at the beginning of the placebo lead-in period (the second visit, based on the test data of the first visit):
36. Fasting blood glucose is greater than 270 mg/dL (greater than 15 millimoles/liter).
37. The calculated creatinine clearance rate is less than 60/ml/min/1.73 m2, or the measured male serum creatinine value is greater than or equal to 1.5 mg/dL (133 millimoles/L) , Female is greater than or equal to 1.4 mg/dL (124 millimoles/L).
38. Urine albumin/creatinine ratio (UACR) greater than 1,800 mg/g
39. Severe liver dysfunction and/or significant liver dysfunction, defined as: aspartate transaminase (AST) greater than 3 times The upper limit of normal (ULN) and/or acetone transaminase (ALT) is greater than 3 times the upper limit of normal.
40. Total bilirubin (bilirubin) is greater than 34.2 micromole/liter, 2.0 mg/dL (upper limit of normal).
41. Positive serological evidence of patients with infectious liver disease, including hepatitis B virus antibody immunoglobulin M (IgM), hepatitis B surface antigen and hepatitis C virus antibody.
42. Creatine kinase is greater than 3 times the upper limit of normal.
43. Male hemoglobin is less than or equal to 10 g/dL; female hemoglobin is less than or equal to 9.5 g/dL.
44. The value of thyroid hormone (TSH) is not within the normal range, and it is further determined that the value of free thyroxine (T4) is abnormal.
45. Any abnormality of clinical significance found in physical examination, electrocardiogram or laboratory test, and determined by the trial physician may affect the safety of the patient during the trial or the successful participation in this trial. Exclusion criteria for random assignment (Visit 3)
46. Systolic blood pressure is greater than or equal to 160 mm Hg, and/or diastolic blood pressure is greater than or equal to 100 mm Hg.
47. Any abnormality of clinical significance found in physical examination, electrocardiogram or laboratory test, and determined by the trial physician may affect the safety of the patient during the trial or the successful participation in this trial.
1. Diagnosed as type 1 diabetes, young type diabetes or secondary diabetes.
2. Received insulin therapy within 24 weeks before being included in the trial (except for use during hospitalization or during pregnancy in patients with gestational diabetes).
3. History of diabetes insipidus.
4. History of diabetic ketoacidosis or other acute or chronic metabolic acidosis.
5. Symptoms of poor diabetes control, including but not limited to the following symptoms: significant polyuria, polydipsia, and/or weight loss of more than 10% within 3 months before being included in the trial.
6. Have received Sitagliptin (DPP-4 inhibitor) treatment before.
7. The body mass index is greater than 45 kg/meter square.
8. History of unstable or rapidly progressing kidney disease.
9. Known congenital renal diabetes.
10. Severe liver and gallbladder disease or history of liver toxicity caused by any drug.
11. Currently pregnant and breastfeeding.
12. Within 30 days before being included in the trial, were receiving glucocorticoids at a dose equivalent to daily oral: Prednisolone greater than 10 mg, Betamethasone greater than 1.2 mg, Dexamethasone greater than 1.5 mg, or greater than 40 Milligrams of Hydrocortisone; but inhaled and smeared corticosteroids (corticosteroids) can be used.
13. Have undergone bariatric surgery.
14. Take weight-loss drugs within 30 days before being included in the trial, including but not limited to the following drugs: Sibutramine, Phentermine, Orlistat, Rimonabant, Benzphetamine, Diethylpropion, Methaphetamine and/or Phendimetrazine.
15. Use antiviral drugs: Delavirdine, Indinavir, Ritonavir, Saquinavir to treat human immunodeficiency virus (HIV), and/or conditions known to have immune insufficiency, including having received an organ transplant.
16. Congestive heart failure, defined as: New York Heart Association (NYHA) grade 3 or 4, unstable congestive heart failure and/or left ventricular ejection fraction (LVEF) less than or equal to 40%.
17. A history of major cardiovascular disease within 6 months before the screening visit, defined as: myocardial infarction, unstable angina, transient ischemic attack, unstable or undiagnosed arrhythmia, cardiac surgery, or vascular reconstruction Surgery (coronary artery repair or bypass graft) or cerebrovascular accident.
18. Severe respiratory failure or emphysema.
19. The systolic blood pressure is greater than or equal to 180 millimeters of mercury (mmHg) and/or the diastolic blood pressure is greater than or equal to 110 millimeters of mercury.
20. Any abnormality of clinical significance found in physical examination, electrocardiogram or laboratory test, and determined by the trial physician may affect the safety of the patient during the trial or the successful participation in this trial.
21. Use Teriparatid, Bisphosphonates and/or Calcitonin at unstable doses (Note: If the dose of Teriparatid, Bisphosphonates and/or Calcitonin remains unchanged within 30 days before being included in the trial, you can enter this trial.).
22. According to the doctor, there may be a risk of dehydration.
23. Suffer from chronic hemolytic anemia or hemoglobin disease (sickle cell anemia or thalassemia, sideroblastic anemia).
24. A medical history of drugs causing liver enzymes to rise.
25. A medical history of drug-induced muscle disease or drug-induced increase in creatine kinase (CK).
26. Acute or chronic metabolic acidosis.
27. Malignant tumors in the past 5 years, except for basal cell or squamous cell skin cancers that have been successfully treated. 28. Have a history of alcohol or illegal drug addiction in the past 12 months.
29. To Dapagliflozin, Metformin, Sitagliptin, Glimepiride, other Sulfonylurea, placebo or formulation excipients intolerance, contraindications or possible allergic reactions.
30. According to the trial physician's judgment, suspected or determined to have poor compliance with the plan's regulations and medication.
31. People who have donated or transfused blood, plasma or platelets within 3 months before the first visit.
32. Participate in the plans and implementation of this trial (applicable to employees of Taiwan Astertec Co., Ltd. and Taiwan Bristol-Myers Squibb Co., Ltd. or test center personnel).
33. Those who have been previously enrolled or randomly assigned to enter this trial to receive treatment.
34. Have previously participated in clinical trials of Dapagliflozin (BMS-512148) and/or any other glucose transporter 2 (SGLT2) inhibitors.
35. Participated in other clinical trials in the past month. The exclusion conditions at the beginning of the placebo lead-in period (the second visit, based on the test data of the first visit):
36. Fasting blood glucose is greater than 270 mg/dL (greater than 15 millimoles/liter).
37. The calculated creatinine clearance rate is less than 60/ml/min/1.73 m2, or the measured male serum creatinine value is greater than or equal to 1.5 mg/dL (133 millimoles/L) , Female is greater than or equal to 1.4 mg/dL (124 millimoles/L).
38. Urine albumin/creatinine ratio (UACR) greater than 1,800 mg/g
39. Severe liver dysfunction and/or significant liver dysfunction, defined as: aspartate transaminase (AST) greater than 3 times The upper limit of normal (ULN) and/or acetone transaminase (ALT) is greater than 3 times the upper limit of normal.
40. Total bilirubin (bilirubin) is greater than 34.2 micromole/liter, 2.0 mg/dL (upper limit of normal).
41. Positive serological evidence of patients with infectious liver disease, including hepatitis B virus antibody immunoglobulin M (IgM), hepatitis B surface antigen and hepatitis C virus antibody.
42. Creatine kinase is greater than 3 times the upper limit of normal.
43. Male hemoglobin is less than or equal to 10 g/dL; female hemoglobin is less than or equal to 9.5 g/dL.
44. The value of thyroid hormone (TSH) is not within the normal range, and it is further determined that the value of free thyroxine (T4) is abnormal.
45. Any abnormality of clinical significance found in physical examination, electrocardiogram or laboratory test, and determined by the trial physician may affect the safety of the patient during the trial or the successful participation in this trial. Exclusion criteria for random assignment (Visit 3)
46. Systolic blood pressure is greater than or equal to 160 mm Hg, and/or diastolic blood pressure is greater than or equal to 100 mm Hg.
47. Any abnormality of clinical significance found in physical examination, electrocardiogram or laboratory test, and determined by the trial physician may affect the safety of the patient during the trial or the successful participation in this trial.
The Estimated Number of Participants
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Taiwan
50 participants
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Global
494 participants
