EUCTR2009-012806-37-PL进行中（未招募）不适用
A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, International Phase III Study with a 24-week Extension Period to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg Daily in Patients with Type 2 Diabetes who have Inadequate Glycaemic Control on a DPP-4 inhibitor (Sitagliptin) Alone or in Combination with Metformin
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 810
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Provision of informed consent prior to any study specific procedures 2. Diagnosis of type 2 diabetes 3. Men or women age =18 years old (for patients taking metformin, the upper age limit should be based on local metformin label restrictions) 4. Current antihyperglycaemic treatment: - Drug naïve (defined as no antihyperglycaemic therapy for at least 10 weeks prior to enrolment), or - Ongoing treatment with sitagliptin monotherapy 100 mg QD for at least 10 weeks prior to enrolment, or - Ongoing treatment with vildagliptin monotherapy 50 mg BID for at least 10 weeks prior to enrolment, or - Ongoing treatment with metformin IR or XR monotherapy =1500 mg/day for at least 10 weeks prior to enrolment, or - Ongoing treatment with metformin IR or XR =1500 mg/day plus sitagliptin 100 mg/day for at least 10 weeks prior to enrolment, or - Ongoing treatment with metformin IR or XR =1500 mg/day plus vildagliptin 50 mg BID for at least 10 weeks prior to enrolment. 5. HbA1c: At enrolment (Visit 1) - =7.2% and =10.0% for patients entering the study on sitagliptin100 mg QD or vildagliptin 50 mg BID monotherapy, sitagliptin 100 mg QD plus metformin =1500 mg/day or vildagliptin 50 mg BID plus metformin =1500 mg/day - =7.7% and =10.5% for patients who are drug naïve or who are treated with metformin =1500 mg/day monotherapy 6. Women of childbearing potential who comply with defined criteria.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Diagnosis of Type 1 diabetes mellitus, known diagnosis of MODY or secondary diabetes mellitus 2. History of diabetic ketoacidosis 3. Symptoms of poorly controlled diabetes including, but not limited to, marked polyuria, polydipsia, and/or greater than 10% weight loss during the 3 months prior to enrolment 4. FPG >270 mg/dL (>15 mmol/L) 5. History of bariatric surgery 6. Diabetes insipidus 7. Thyroid-stimulating hormone (TSH) values outside normal range 8. Renal failure or renal dysfunction (Calculated Creatinine Clearance <50 mL/min calculated by Cockroft-Gault formula for patients not taking metformin, further specified for patients taking metformin; Urine albumin: creatinine ratio >1800 mg/g (>203.4 mg/mmol)) 9. Known condition of familial renal glucosuria 10. AST >3 xULN and/or ALT >3 x ULN, total bilirubin >2.0 mg/dL (>34.2 µmol/L) 11. Congestive heart failure NYHA class IV, unstable or acute congestive heart failure 12. Significant cardiovascular history within the past 3 months prior to the screening visit (myocardial infarction, unstable angina pectoris, transient ischemic attack, unstable or previously undiagnosed arrhythmia, cardiac surgery or revascularization, cerebrovascular accident), unstable cardiovascular disease at enrolment as judged by investigator 13. Systolic BP =170 mmHg and/or diastolic BP =110 mmHg 14. Haemoglobin =10 g/dL (=100 g/L) for men; haemoglobin =9.0 g/dL (=90 g/L) for women 15. Creatinine Kinase >3X ULN, history of drug-induced myopathy or drug-induced CK elevation 16. Use of: antihyperglycaemic medications other than DPP-4 inhibitors or metformin during the 10 weeks prior to enrolment, insulin within 24 weeks of enrolment (with exceptions), weight loss medication (including but not limited to sibutramine, phentermine, orlistat, rimonabant, benzphetamine, diethylproprion, methamphetamine, and/or phendimetrazine) within 30 days prior to enrolment, glucocorticoids equivalent to oral prednisolone =10 mg (betametasone =1.2 mg, dexamethasone =1.5 mg, hydrocortisone =40 mg) per day within 30 days prior to enrolment, unstable doses of teriparatide, bisphosphonates and/or calcitonin, antiviral drugs 17. Patients at risk of dehydration 18. Acute or chronic metabolic acidosis.
研究者
相似试验
进行中（未招募）
1 期
A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, International Phase III Study with a 24-week Extension Period to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg Daily in Patients with Type 2 Diabetes who have Inadequate Glycaemic Control on a DPP-4 inhibitor (Sitagliptin) Alone or in Combination with MetformiMedDRA version: 12.0 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependentType 2 Diabetes MellitusEUCTR2009-012806-37-GBAstraZeneca AB810
进行中（未招募）
不适用
A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IIIb tudy to Evaluate the Efficacy and Safety of Saxagliptin in Combination with Metformin and Sulfonylurea in Subjects with Type 2 Diabetes who have Inadequate Glycaemic control with the Combination of Metformin and SulfonylureaType 2 diabetes mellitusMedDRA version: 12.1Level: LLTClassification code 10067585Term: Type 2 diabetes mellitusEUCTR2010-019428-30-GBAstraZeneca Singapore Pte Ltd275
已完成
3 期
A study to Evaluate the Efficacy and Safety of Saxagliptin in Combination with Metformin and Sulfonylurea in Subjects with Type 2 DiabetesCTRI/2010/091/001110AstraZeneca Singapore Pte Ltd69
进行中（未招募）
不适用
Evaluation of Safety and Efficacy of Dapagliflozin in subjects with Type 2 Diabetes who have Inadequate Glycaemic Control on background combination of Metformin and SulfonylureaType II diabetes mellitusMedDRA version: 14.0Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependentSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2011-002231-26-SKAstraZeneca AB216
进行中（未招募）
1 期
Evaluation of Safety and Efficacy of Dapagliflozin in subjects with Type 2 Diabetes who have Inadequate Glycaemic Control on background combination of Metformin and SulfonylureaType II diabetes mellitusMedDRA version: 14.0Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependentSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2011-002231-26-ESAstraZeneca AB218