EUCTR2017-002309-36-DE进行中（未招募）1 期
A randomized, double-blind, parallel-group, 2-treatment multiple dose study to assess the intestinal, metabolic and cardiovascular effects of an 8 weeks treatment with sotagliflozin QD as compared with empagliflozin QD in T2DM patients with mild to moderate hypertension
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
- 40
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
- •-Male or female patients with Type 2 Diabetes Mellitus (T2DM)
- •(diagnosed at least 1 year before screening visit), between 18 and 74 years of age, inclusive, with:
- •-Hypertension grades 1 or 2 as defined by the European Society of Hypertension (ESH)/European Society of Cardiology (ESC) at screening; SBP (systolic blood pressure) has to be in the range of 140-179 mmHg (after 10 minutes resting in supine position, measurement in triplicate with each measurement to be within this range at screening). If the
- •blood pressure (BP)range is not met at screening, one repeat
- •measurement at another occasion is allowed prior to inclusion into the study.
- •-Glycated Haemoglobin A1c (HbA1c) at screening between 6.5% and 11%.
- •-On a stable treatment with metformin, ie, no change in dose regimen or in dose levels in the last 3 months prior to screening and until randomization.
- •-On a stable treatment with an ACE inhibitor or an angiotensin receptor blocker after switching from beta-blockers and/or thiazides for eligible patients after screening, ie, no change in dose regimen and in dose levels in the last 4 weeks prior to run-in phase and until randomization
- •-Body weight between 50.0 kg and 130 kg, inclusive, if male, and
- •between 40.0 kg and 110 kg, inclusive, if female, body mass index
- •between 18.0 and 38.0 kg/m2, inclusive.
- •-Kidney function: Estimated glomerular filtration rate at screening must be 60 mL/min/1.73m2 or higher.
- •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 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Patients with severe anemia, severe cardiovascular, gastrointestinal,respiratory, neurological, osteomuscular, psychiatric, or active malignant tumor or other major systemic disease or patients with infectious disease, signs of acute illness, or short life expectancy making implementation of the protocol or interpretation of the study results
- •difficult (as evaluated by detailed medical history and complete physical
- •and laboratory examination).
- •-Heart failure New York Heart Association (NYHA) Classification III/IV.
- •-Any clinically significant abnormality in echocardiography performed at
- •screening as judged by the investigator based on age, gender and
- •medical history of the individual patient.
- •-History of myocardial infarction within the last 12 months prior to
- •-Likelihood of requiring treatment during the study period with drugs
- •not permitted by the study protocol (e.g., long-term systemic
- •glucocorticoids) and refusing or unable to take alternative treatment.
- •-Type 1 diabetes mellitus.
- •-Secondary hypertension of any etiology (eg, renovascular disease,
- •pheochromocytoma, Cushing's syndrome).
- •-Clinically significant pulmonary hypertension, in particular World Health
- •Organisation (WHO) Classes IV (Pulmonary hypertension due to chronic
- •thrombotic and/or embolic disease [CTEPH]) and V (miscellaneous).
- •-Diabetic retinopathy.
- •-History of diabetic ketoacidosis or non-ketotic hyperosmolar coma
- •within 12 weeks prior to the Screening Visit.
- •-History of severe hypoglycemia resulting in hospitalization or
- •unconsciousness/seizures within 6 months prior to the Screening visit.
- •-History of prior gastric or intestinal surgical procedure including gastric
- •banding within 3 years before the Screening Visit. Any gastrointestinal
- •surgery with removal of part of the bowels or the stomach
- •-History of unexplained pancreatitis, chronic pancreatitis,
- •stomach/gastric surgery, inflammatory bowel disease.
- •-Known hypersensitivity to sotagliflozin, empagliflozin or any excipient
- •of the drug products.
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