NCT02426541已完成4 期
An 8-week, Single Centre, Randomized, Parallel-group, Double-blind, Placebo Controlled Phase IV Study to Evaluate Dapagliflozin 10 mg Once Daily Effects on Insulin Resistance in Subjects With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Adjusted Change From Baseline in Skeletal Muscle Insulin-stimulated Gluocose Uptake
研究概览
简要总结
This is an 8-week, single centre, randomized, parallel-group, double-blind, placebo-controlled Phase IV study to evaluate the effect of dapagliflozin on tissue specific insulin sensitivity in patients with Type 2 diabetes mellitus
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed informed consent prior to any study specific procedures.
- •Female or male aged 35 to 70 years inclusive with suitable veins for cannulation or repeated venipuncture
- •Type 2 Diabetes mellitus defined as HbA1c of ≥ 6.5% and ≤ 10.5%.
- •Stable (≥ 3 months) T2D treatment with metformin and/or metformin+dipeptidyl peptidase-4 inhibitors (DPP-IV)
- •Body mass index (BMI) ≤ 40 kg/m
- •Female subjects must be of non-childbearing potential, meeting at least one of the following criteria:
- •Hysterectomized females
- •Postmenopausal women, defined as women who have not had a menstrual period within 1 year
排除标准
- •Any condition that is contraindicated with MRI such as, but not limited to, having a pacemaker or claustrophobia.
- •Volume depleted patients. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status.
- •Recent Cardiovascular Events in a patient:
- •Acute Coronary Syndrome (ACS) within 2 months prior to enrolment
- •Hospitalization for unstable angina or acute myocardial infarction within 2 months prior to enrolment
- •Acute Stroke or Transient Ischemic Attack (TIA) within two months prior to enrolment
- •Less than two months post coronary artery revascularization
- •Congestive heart failure defined as New York Heart Association (NYHA) class IV, unstable or acute congestive heart failure.
- •Blood pressure at enrolment: Systolic BP ≥165 mm Hg and/or diastolic BP ≥100 mm Hg
- •Any clinically significant illness, medical or surgical procedure or trauma within 4 weeks of the first administration of the investigational product.
- •On insulin, GLP-1 or other oral antidiabetic drug treatment (metformin or both metformin and DPP-IV allowed) or using other medications known to affect glucose metabolism.
- •Any clinically significant abnormalities in physical examination, Electrocardiography (ECG) or clinical chemistry results as judged by the investigator. The following specific exclusion criteria apply to the selected Clinical Chemistry results:
- •Creatinine clearance <60mL/min (estimated with Cockroft-Gault formula).
- •Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN.
- •Total bilirubin (TB) >2.0 mg/dL (34.2 µmol/L).
- •Body weight loss greater than 5% within 3 months prior to Visit
- •Previous PET scan
- •History of or presence of (as found at Visit 1) any clinically significant disease, disorder or condition which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
研究组 & 干预措施
Dapagliflozin
Experimental
Dapagliflozin Once Daily 10 mg
干预措施: Dapagliflozin (Drug)
Placebo
Placebo Comparator
Matching placebo for Dapagliflozin Once Daily 10 mg
干预措施: Placebo (Drug)
结局指标
主要结局
Adjusted Change From Baseline in Skeletal Muscle Insulin-stimulated Gluocose Uptake
时间窗: From baseline to Week 8
Adjusted change from baseline in skeletal muscle insulin-stimulated gluocose uptake (umol/min/kg)
次要结局
- Adjusted Change in Liver Insulin-stimulated Glucose Uptake From Baseline to Week 8(Baseline to Week 8)
- Adjusted Change in Adipose Tissue Insulin-stimulated Glucose Uptake(Baseline to Week 8)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
A Trial of Solriamfetol in the Treatment of Myalgic Encephalomyelitis/Chronic Fatigue SyndromeMyalgic EncephalomyelitisChronic Fatigue SyndromeNCT04622293Rochester Center for Behavioral Medicine44
招募中
不适用
8 weeks, single-center, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of Rubus coreanus extract on inhibition of platelet aggregation and blood coagulatioKCT0000915ee’s Biotech80
招募中
不适用
Clinical trial for the efficacy of CJ_AJ on blood circulatioKCT0001031Ajou University42
尚未招募
不适用
8 weeks, single-center, randomized, double-blind, placebo-controlled human study to assess the efficacy and safety of Aloe Extract Complex on inhibition of platelet aggregation and blood circulation.KCT0000902Kim Jeong Moon Aloe90
已完成
1 期
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06882961 in Japanese Adults With Type 2 Diabetes MellitusType 2 Diabetes MellitusNCT04552470Pfizer37