EUCTR2017-001351-31-GB
Active, not recruiting
Phase 1
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 sites28 target enrollmentJune 9, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Type 2 diabetes
- Sponsor
- niversity of Leeds
- Enrollment
- 28
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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