A study to assess the safety, rationale and effect of a new treatment to improve skin function and wound healing in patients with type 2 diabetes
- Conditions
- Type 2 diabetesMedDRA version: 20.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2017-001351-31-GB
- Lead Sponsor
- niversity of Leeds
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 28
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method