EUCTR2014-003313-28-DE进行中（未招募）1 期
SGLT2 inhibition with empagliflozin in patients with type 2 diabetes mellitus: Influences on left ventricular mass, function, and cardiac lipid content (EMPATROPHY) - Empagliflozin and left ventricular mass
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
- 60
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. women and men = 40 and < 80 years of age
- •2. patients with type 2 diabetes mellitus on stable anti-diabetic treatment for the last 3 months; at screening the following treatment conditions are allowed:
- •metformin + sulfonylurea with HbA1c = 6.5% and = 9.0%
- •metformin monotherapy with HbA1c = 7.5% and = 9.0%
- •metformin + DPP-IV inhibitor withHbA1c = 6.5% and = 9.0%
- •3. waist circumference = 80 cm in women or = 94 cm in men
- •4. office blood pressure = 150/95 mm Hg with a stable dose of a maximum of 4 antihypertensive medications for the last 3 months (24h ambulatory blood pressure measurement (ABPM) is allowed to check accuracy of office values; inclusion with 24h mean blood pressure = 145/90 mm Hg is possible)
- •5. women without childbearing potential defined by:
- •at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy
- •hysterectomy
- •= 50 years and in postmenopausal state > 1 year
- •< 50 years and in postmenopausal state > 1 year with serum FSH > 40 IU/l and serum estrogen< 30 ng/l or a negative estrogen test, both at screening
- •6. women of childbearing potential with a negative serum ß-hCG pregnancy test at screening who agree to meet one of the following criteria from the time of screening, during the study and for a period of 4 days following the last administration of study medication:
- •correct use of reliable contraception methods. The following are acceptable: hormonal contraceptives (combined oral contraceptives, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release), intrauterine device (IUD/IUS) or a double barrier method, e.g. condom and occlusive cap (diaphragm or cervical/vault caps) with spermicide (foam, gel, film, cream or suppository)
- •true abstinence (periodic abstinence and withdrawal are not acceptable methods of contraception)
- •sexual relationship only with female partners
- •sterile male partners
- •7. signed written informed consent and willingness to comply with treatment and follow-up
- •8. capability of understanding the investigational nature, potential risks and benefits of the clinical trial
- •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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. diabetes mellitus type 1
- •2. uncontrolled diabetes mellitus type 2 with fasting glucose > 13.3 mmol/l confirmed on a second day
- •3. previous treatment with insulin, GLP-1 analogues, or pioglitazone during the last year before screening
- •4. previous participation in another empagliflozin trial
- •5. acute illness at screening or randomization according to judgement by the investigator or patient
- •6. known or suspected hypersensitivity to empagliflozin, glimepiride or any excipients; known or suspected hypersensitivity to sulfonylureas or sulfonamides
- •7. history of multiple severe hypoglycemic episodes
- •8. any condition prohibiting MRI studies (e.g. metal implants, claustrophobia, body weight too high)
- •9. patient akctively attempted to lose weight or experienced unintentional clinically significant weight loss during the last 3 months
- •10. bariatric surgery or other gastrointestinal surgery procedures that induce chronic malabsorption
- •11. treatment with any weight loss drug in the preceding 6 months
- •12. planned significant changes of pre-study physical activity level during study participation
- •13. heart failure NYHA III – IV
- •14. patients with known severe cardiovascular disease (e.g. myocardial infarction, unstable angina, stable coronary artery disease, stroke or transient ischemic attack)
- •15. eGFR <60 ml/min/1,73 m²
- •16. treatment with loop diuretics
- •17. acute or chronic diarrhea, any clinical signs of volume depletion or a hematocrit > 48 % (women) and > 53 % (men)
- •18. chronic lower urinary tract infections
- •19. known acute or chronic liver disease or screening ALT or AST > 3 x ULN
- •20. serum potassium < 3.6 or > 5.0 mmol/l
- •21. glucose-6-phosphate dehydrogenase deficiency
- •22. anemia of unknown origin
- •23. pregnancy or lactation period
- •24. treatment with systemic glucocorticoids during the last 3 months before screening
- •25. chronic treatment with NSAIDs
- •26. changes in thyroid hormone dosage (stable doses of thyroid hormones for the last 3 months are acceptable)
- •27. history of drug or alcohol abuse or current abuse
- •28. psychosomatic or psychiatric diseases requiring hospitalization during the last 12 months; ongoing treatment with one tricyclic or SSRI antidepressant drug at a stable dose since the last 3 months is acceptable
- •29. medical history of cancer except for strictly localized tumors
- •30. any planned medical or surgical intervention planned for the next 7 months after randomization that does not allow study participation according to the investigator´s judgment
- •31. current participation in any other clinical trial or participation in another clinical trial within 30 days before screening
研究者
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