EUCTR2015-001702-33-ES进行中（未招募）1 期
A 24-week International, Multicenter, Randomized, Open-Label, Active-Controlled, Parallel Group, Phase 3b Trial with a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered with Dapagliflozin Compared to Insulin Glargine in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin with or without Sulfonylurea Therapy
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
- 598
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
- •? Males and females aged ? 18 years old at the time of screening visit.
- •? Subjects with T2DM with inadequate glycemic control, defined as a central laboratory HbA1c ? 8 % and ? 12 % obtained at the screening visit.
- •? Note: At Week -2 (Lead-In), a central laboratory fasting plasma glucose (FPG) qualification check will be performed. Subjects will only be randomized on Day 1 if their FPG is ? 270 mg/dL (15 mmol/L) at the Week -2 qualification check. A re-test will be permitted within (7) days if the Week -2 central lab FPG result was > 270mg/dL (15 mmol/L) but < 300 mg/dL (16.6 mmol/L). Subjects will be excluded if the central lab FPG value at Week -2 (Lead-In) is ? 300 mg/dL (16.6 mmol/L) or if the central lab FPG value at Week -2 (Lead-In) and the re-test FPG value are both > 270 mg/dL (15 mmol/L).
- •? Subjects must be taking a stable dose of metformin ? 1500 mg/day for at least 8 weeks prior to screening visit with or without a stable dose of SU of at least 50% maximal dose per local label for at least 8 weeks prior to screening visit. Subjects must not take any other antidiabetic therapy for more than 14 days (consecutive or not) during 12 weeks prior to screening.
- •? BMI ? 45.0 kg/m2 at the screening visit.
- •? Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) at screening and within 24 hours prior to the start of study drug.
- •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 478
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •? Clinical diagnosis of Type 1 Diabetes.
- •? History of unstable or rapidly progressing renal disease, hepatic insufficiency or current, acute or chronic pancreatitis.
- •? Any of the following cardiovascular/vascular diseases within 3 months of enrollment visit: MI, CABG, PTCA, valvular disease or repair, unstable angina or unstable CHF, TIA, Class III or IV heart failure, known left ventricular ejection fraction of < 40%, or significant cerebrovascular disease.
- •? Impairment of renal function (defined as creatinine clearance [CrCl] < 60 mL/min [estimated by Cockcroft-Gault] or serum creatinine [SCr] ? 1.5 mg/dL in males or ? 1.4 mg/dL in females).
- •? 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.
- •? Hematological or oncological diseases or conditions.
- •? Participation in a commercial weight loss program or history of bariatric surgery.
- •? Replacement or chronic systemic corticosteroid therapy.
- •? Administration of any other investigational drug or participation in any interventional clinical study within (30) days prior to screening for this study.
研究者
相似试验
进行中（未招募）
1 期
A comparison of treatment with Saxagliptin and Dapagliflozin against Insulin Glargine in Type 2 Diabetes patients whose current treatment of Metformin with or without Sulfonylurea Therapy is not adequate.Type 2 diabetes mellitus and inadequate glycemic control on a stable dose of metforminMedDRA version: 19.0Level: LLTClassification code 10049746Term: Insulin-requiring type II diabetes mellitusSystem Organ Class: 100000004861MedDRA version: 19.0Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate controlSystem Organ Class: 100000004861MedDRA version: 19.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861EUCTR2015-001702-33-HUAstraZeneca AB598
进行中（未招募）
1 期
A comparison of treatment with Saxagliptin and Dapagliflozin against Insulin Glargine in Type 2 Diabetes patients whose current treatment of Metformin with or without Sulfonylurea Therapy is not adequate.Type 2 diabetes mellitus and inadequate glycemic control on a stable dose of metforminMedDRA version: 19.1Level: LLTClassification code 10049746Term: Insulin-requiring type II diabetes mellitusSystem Organ Class: 100000004861MedDRA version: 19.1Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate controlSystem Organ Class: 100000004861MedDRA version: 19.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861EUCTR2015-001702-33-DEAstraZeneca AB598
进行中（未招募）
1 期
A comparison of treatment with Saxagliptin and Dapagliflozin against Insulin Glargine in Type 2 Diabetes patients whose current treatment of Metformin with or without Sulfonylurea Therapy is not adequate.Type 2 diabetes mellitus and inadequate glycemic control on a stable dose of metforminMedDRA version: 19.0Level: LLTClassification code 10049746Term: Insulin-requiring type II diabetes mellitusSystem Organ Class: 100000004861MedDRA version: 19.0Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate controlSystem Organ Class: 100000004861MedDRA version: 19.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861EUCTR2015-001702-33-DKAstraZeneca AB598
进行中（未招募）
1 期
A comparison of treatment with Saxagliptin and Dapagliflozin against Insulin Glargine in Type 2 Diabetes patients whose current treatment of Metformin with or without Sulfonylurea Therapy is not adequate.Type 2 diabetes mellitus and inadequate glycemic control on a stable dose of metforminMedDRA version: 20.0Level: LLTClassification code 10049746Term: Insulin-requiring type II diabetes mellitusSystem Organ Class: 100000064343MedDRA version: 20.0Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate controlSystem Organ Class: 100000019249MedDRA version: 20.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000072461EUCTR2015-001702-33-CZAstraZeneca AB598
进行中（未招募）
1 期
A comparison of treatment with Saxagliptin and Dapagliflozin against Insulin Glargine in Type 2 Diabetes patients whose current treatment of Metformin with or without Sulfonylurea Therapy is not adequate.Type 2 diabetes mellitus and inadequate glycemic control on a stable dose of metforminMedDRA version: 19.0Level: LLTClassification code 10049746Term: Insulin-requiring type II diabetes mellitusSystem Organ Class: 100000004861MedDRA version: 19.0Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate controlSystem Organ Class: 100000004861MedDRA version: 19.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861EUCTR2015-001702-33-SEAstraZeneca AB598