EUCTR2016-003991-27-NL
进行中（未招募）
1 期
MAAST: A Double-blind, Randomized, Phase IV, Mechanistic, Placebo-controlled, Cross-over, Single-center Study to Evaluate the Effects of 5 Weeks Dapagliflozin Treatment on Insulin Sensitivity in Skeletal Muscle in Type 2 Diabetes Mellitus Patients - DAPAMAAST
适应症Study to investigate mitochondrial function and insulin sensitivity in skeletal muscle in subjects with T2DM.Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
相关药物Forxiga
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Study to investigate mitochondrial function and insulin sensitivity in skeletal muscle in subjects with T2DM.
- 发起方
- AstraZeneca AB
- 入组人数
- 26
- 状态
- 进行中（未招募）
- 最后更新
- 5年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Provision of signed and dated, written informed consent prior to any study specific procedures
- •Post\-menopausal females aged between \= 45 and \= 70 years and/or males aged between \= 40 years and \= 70 years. Patients should have suitable veins for cannulation or repeated venipuncture.
- •Patients diagnosed with T2DM for at least the last 6 months, based on American Diabetes Association 2016 standards.
- •Patients on no other anti\-diabetic drug treatment, or on stable maximum 3000 mg daily dose metformin treatment and/or on stable dose of a DPPIV inhibitor treatment for at least the last 3 months
- •HbA1c levels \=6\.0% (\=42 mmol/mol) and \=9\.0% (75 mmol/mol)
- •Body mass index (BMI) \= 38 kg/m2
- •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 18
排除标准
- •Any of clinically significant disease or disorder including a recent cardiovascular event
- •Diagnosis of Type 1 Diabetes Mellitus, maturity onset diabetes of the young, secondary diabetes or diabetes insipidus
- •Unstable/rapidly progressing renal disease or estimated Glomerular Filtration Rate \< 60 mL/min (Cockcroft\-Gault formula)
- •History of drug abuse or alcohol abuse in the past 12 months
- •Any clinically significant abnormalities in clinical chemistry, hematology or urinalysis
- •Contraindications to dapagliflozin according to the local label
- •Anemia defined as Hemoglobin (Hb) \< 115 g/L (7\.1 mM) in women and \< 120 g/L (7\.5 mM) in men.
- •Use of anti\-coagulant treatment
- •Use of medication such as oral glucocorticoids, anti\-estrogens or other medications that are known to markedly influence insulin sensitivity
- •Use of loop diuretics
结局指标
主要结局
未指定
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