EUCTR2015-005549-30-SE进行中（未招募）1 期
A single-dose cross-over study to assess direct and indirect effects of dapagliflozin on pancreatic alpha and beta cells in patients with type 2 diabetes
Dept of Medical Sciences, Clinical Diabetes and Metabolism, Uppsala University0 个研究点目标入组 15 人开始时间: 2015年12月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
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.Males and females aged 18 – 75.
- •2.Female subjects must meet all of the following criteria:
- •a)Not breastfeeding
- •b)Negative pregnancy test result (human chorionic gonadotropin, beta subunit [?hCG]) at Visit 1 (Enrolment) (not applicable to hysterectomized females).
- •c)If of childbearing potential (including perimenopausal women who have had a menstrual period within 1 year), must practice and be willing to continue to practice one of the following highly effective birth control methods during the entire duration of the study:
- •i.Diaphragm or partner use of condom in combination with combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
- •Intravaginal
- •Transdermal
- •ii.Diaphragm or partner use of condom in combination with progestogen-only hormonal contraception associated with inhibition of ovulation:
- •Injectable
- •Implantable
- •iii.Placement of an intrauterine device
- •iv.Placement of an intrauterine hormone-releasing system
- •v.Bilateral tubal occlusion
- •vi.Vasectomised partner (provided that the partner is the sole sexual partner of the female subject and that the vasectomised partner has received medical assessment of the surgical success)
- •vii.Sexual abstinence (defined as refraining from heterosexual intercourse)
- •d)Must practice appropriate birth control as stated above for 10 weeks after the last dose of study medication
- •3.BMI 20 – 35.
- •4.Clinical T2D diagnosis at least 6 months prior to experiment initiation.
- •5.Metformin treatment, with stable dose for at least 1 month.
- •6.HbA1c 55 – 86 mmol/mol (7,2-10 % DCCT).
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Exclusion Criteria:
- •1.History or sign of any clinically significant disease or disorder 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.
- •2.Clinical diagnosis of Type 1 diabetes mellitus and/or history of diabetic ketoacidosis or positive Glutamic Acid Decarboxylase Autoantibodies test (GAD antibodies test).
- •3.Patients treated with antipsychotics, systemic glucocorticoids, neuropsychiatric stimulants, antidepressants with sympathetic activity, beta blockers or other pharmaceuticals rendering patient unfit for study participation as judged by the investigator.
- •4.Patients treated with antidiabetic medications other than Metformin.
- •5.Patients with any other endocrine disease except substituted hypothyroidism.
- •6.Significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN.
- •7.Patients with impaired liver or kidney function (eGFR < 60).
- •8.Known or suspected history of significant drug abuse.
- •9.History of alcohol abuse or excessive intake of alcohol as judged by investigator.
- •10.History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator.
- •11.Plasma donation within one month of screening or any blood donation or significant blood loss (> 400 ml) during the 3 months prior to screening.
- •12.Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study and /or for the patients safety.
- •13.Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- •14.Judgment by the investigator that the subject should not participate in the study if considers subject unlikely to comply with study procedures, restrictions and requirements.
研究者
相似试验
已完成
不适用
A single dose two-phase crossover study to assess the tolerability and pharmacokinetic parameters of a fixed dose formulation of artesunate-mefloquine and standard dose artesunate and mefloquine as loose tablets in healthy normal volunteers (Thailand)Pharmacokinetics of drugISRCTN22508774Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
已完成
不适用
A study to assess the processing of nicotine by the body and subjective effects of oral nicotine products in healthy adult users of cigarettes and smokeless pouch productsicotine uptake and subjective measuresISRCTN10633589British American Tobacco (United Kingdom)40
已完成
不适用
A Randomized, Single-dose, Cross-over Study to Investigate the Suitability of Multiple Placebo Mini-tablet Administration in Small Childreo specific disease. Placebo Administration to hospitalised patients.DRKS00008843Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie, Universitätsklinik Düsseldorf374
已完成
不适用
A Randomized, Single-dose, Cross-over Study to Investigate the Acceptability of an Orodispersible Film Compared to Syrup in Neonates and Infantso specific disease. Placebo Administration to hospitalised patients.DRKS00011325Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie, Universitätsklinik Düsseldorf150
已完成
1 期
An open randomized single dose cross-over study to investigate the relative bioavailability (BA) of different formulations containing crystalline glucosamine sulphate: Film-coated tablet (dona® 750 mg) and oral soluble powder formulation presented as a sachet (dona® 1500 mg) in healthy subjects under different fasted and fed conditionshealthy subjectsDRKS00008766MEDA Pharma GmbH & Co. KG (a Mylan company), Scientific Affairs, Head of Clinical Affairs Meda39