EUCTR2014-001102-17-PL进行中（未招募）1 期
A 26-week International, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase 3bTrial with a Blinded 26-week Long -term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered with Dapagliflozin in Combination with Metformin Compared to Sitagliptin in Combination with Metformin in Adult Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone. - NA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 420
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. Signed Written Informed Consent
- •a) Subjects (or designee) must be willing and able to give signed and dated written informed consent.
- •2. Target Population
- •a) Patients with T2DM with inadequate glycemic control, defined as a central laboratory HbA1c = 8.0% and = 10.5 % obtained at the screening visit.
- •i) Note: At Week -2 (Lead-In), a qualification check will be performed and subjects will be inclusive if their FPG is = 270 mg/dl (15 mmol/l). A re-test will be permitted within 7 days if the initial result was > 270mg/dl but < 300mg/dl (16.7 mmol/l). Subjects will be excluded if the mean value of the Week -2 (Lead-In) result and the re-test result is > 270mg/dl.
- •b) Subjects should have been taking the same daily dose of metformin = 1500 mg for at least 8 weeks prior to the enrollment visit and with no intake of other antihyperglycemic therapy for more than 14 days (consecutive or not) during 12 weeks prior to screening.
- •c) BMI > 20.0 kg/m2 at the enrollment visit.
- •3. Inclusion criteria at randomization (visit 3, based on laboratory results from visit 2): a) FPG = 270 mg/dL (= 15 mmol/L).
- •4. Age and Reproductive Status
- •a) Males and Females, age = 18 years old at time of screening visit.
- •b) Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
- •c) Women must not be breastfeeding.
- •d) WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drugs: Saxagliptin, Dapagliflozin, and Sitagliptin (30 days) plus 30 days (duration of ovulatory cycle) for a total of 60 days post-treatment completion.
- •e) Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drugs: Saxagliptin, Dapagliflozin, and Sitagliptin plus 5 half-lives of the study drug (30 days) plus 90 days (duration of sperm turnover) for a total of 120 days post treatment completion.
- •f) Azoospermic males and WOCBP who are not continuously heterosexually active are exempt from contraceptive requirements. However they must still undergo pregnancy testing as described in protocol.
- •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 336
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 84
排除标准
- •1.Target Disease Exceptions
- •a) Clinically diagnosed with Type I diabetes, known diagnosis of Maturity Onset Diabetes of Young (MODY), secondary diabetes mellitus or diabetes insipidus.
- •b) History of diabetic ketoacidosis
- •2. Medical History and Concurrent Diseases
- •a) Any of the following CV/Vascular Diseases within 3 months of the enrollment visit: Myocardial infarction, cardiac surgery or revascularization, unstable angina, unstable congestive heart failure, transient ischemic attack or significant cerebrovascular disease, unstable or previously uniagnosed arrhythmia, congestive heart failure or unstable or acute congestive heart failure and/or known left ventricular ejection fraction of = 40%.
- •b) Renal Disease: History of unstable or rapidly progressing renal disease, impairment of renal function, history of unexplained microscopic or gross hematuria, or microscopic hematuria at screening, confirmed by a follow-up sample at next scheduled visit, where according to the investigator a satisfactory evaluation of hematuria has not been conducted based on guidance in Section 5.3.2.. Not applicable as per Protocol Amendment Number 1, hematuria (confirmed by microscopy at screening) with no explanation as judged by the investigator up to randomization. If bladder cancer is identified, subjects are not eligible to participate.
- •c) Hepatic/GI Diseases: severe hepatic insufficiency and/or significant abnormal liver function, serum total bilirubin (TB) > 2 mg/dL (> 34.2 µmol/L) at the time of screening, history of, or current, acute pancreatitis, severe hepatic disease, including chronic active hepatitis. Positive serologic evidence of current infectious liver disease, including patient's positive for Hepatitis B viral antibody IgM, Hepatitis B surface antigen, and Hepatitis C virus antibody
- •d) Hematological and Oncological Disease/Conditions: History of hemoglobinopathy, with the exception of sickle cell trait (SA) or thalassemia minor; or chronic or recurrent hemolysis, history of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
- •3.Physical and Laboratory Test Findings at the time of screening
- •a) Hemoglobin =110 g/L for men; hemoglobin = 100 g/L for women
- •b) Abnormal Free T4
- •c) Any clinically significant abnormality identified on physical examination, ECG or laboratory tests, which in the judgment of the investigator would compromise the patient’s safety or successful participation in the study
- •4. Other Exclusion Criteria
- •a) Subjects who have contraindications to therapy as outlined in the saxagliptin and dapagliflozin Investigator Brochure, the local saxagliptin or dapagliflozin package insert or the local metformin package insert, or the local sitagliptin package insert, including current treatment with potent cytochrome P450 3A4/5 inhibitors
- •b) Prisoners or subjects who are involuntarily incarcerated
- •c) Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness
- •d) Subjects on a commercial weight loss program with ongoing weight loss, or on an intensive exercise program
- •e) History of bariatric surgery or lap-band procedure within 6 months prior to screening
- •f) Replacement or chronic systemic corticosteroid therapy, defined as any dose of systemic corticosteroid taken for > 4 weeks within 3 months prior to the Day 1 visit ( Topical, nasal, or inhaled corticosteroids are allowed)
- •g) Any unstable endocrine, psychiatric or rheumatic disorders as judg
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