EUCTR2017-001351-31-GB进行中（未招募）1 期
A double-blind, randomized, placebo-controlled phase II pilot trial investigating efficacy, safety and feasibility of 11ß-hydroxysteroid dehydrogenase type 1 inhibition by AZD4017 to improve skin function and wound healing in patients with type 2 diabetes - GC-SHealD (Glucocorticoids and Skin Healing in Diabetes) v1.1
niversity of Leeds0 个研究点目标入组 28 人开始时间: 2017年6月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 28
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) Able and willing to provide informed consent
- •2) Clinical diagnosis of T2DM with HbA1c below or equal to 11% (below or equal to 97 mmol/mol) at screening while taking standard therapy at a stable dose for =10 weeks
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1) Women of child-bearing potential (WOCBP). Note: WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea >/= 12 consecutive months or women on hormone replacement therapy with documented serum follicle stimulating hormone level >35 mIU/mL].
- •Additionally, male study participants who are sexually active with a female partner of childbearing potential must be surgically sterilized or agree, along with their partner, to use a highly effective method of birth control (as defined below) from the time of screening until 3 weeks after final dose of study drug (5 drug elimination half-lives plus 2 weeks). Male study participants must also not donate sperm from the time of screening until 3 weeks after final dose of study drug (5 drug elimination half-lives plus 2 weeks).
- •Highly effective methods of contraception are defined as combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (either oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (either oral [such as Cerazette™], injectable or implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner or sexual abstinence.
- •2) Active leg/foot ulceration
- •3) Acute electrocardiogram (ECG) anomalies deemed to be clinically relevant by the CI
- •4) Systemic hypertension (BP >150/90) on 3 successive measurements at the screening visit (patients with controlled hypertension can be included in the trial)
- •5) Any endocrine disorder (other than T2DM), including type 1 or secondary diabetes, except treated hypothyroidism with normal thyroid function tests for at least 3 months
- •6) Suspicion of or known Gilbert's disease
- •7) Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) and/or alkaline phosphatase (ALP) > 1.5x upper limit of normal (ULN)
- •8) Bilirubin (total) > 1.5x ULN
- •9) An eGFR calculated by the Modification of Diet in Renal Disease equation of <45 ml/min/m2
- •10) Creatine kinase (CK) >2 x ULN
- •11) Participant is, at the time of signing the informed consent, a user of recreational or illicit drugs (including marijuana) or has had a recent history (within the last year) of drug or alcohol abuse or dependence on questioning or clinical history
- •12) Receiving any topical, systemic (including vaginal/rectal) or inhaled GC treatment at the time of or within 3 months prior to the screening visit
- •13) Taking any anticoagulant medication (blood thinning e.g. warfarin)
- •14) Taking probenicid or similar (for gout) at the time of inquiry
- •15) Any medical/surgical procedure (excluding skin biopsies) or trauma during IMP administration or within one week following the last administration of the IMP as judged by the CI
- •16) Involved in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- •17) Participated in any other clinical study within 1 calendar month prior to the screening visit (except registry-only participation)
- •18) Deemed otherwise inappropriate to participate by the trial team
研究者
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