Glucocorticoids and Skin Healing in Diabetes (GC-SHealD)

• Status: Completed
• Trial end date: 2019-03-13
• Target enrollment: 0
• Participant gender: All

Summary

The study aims to investigate effects of inhibiting glucocorticoid activation on skin function and wound healing in patients with type 2 diabetes. Half of patients will be given a drug to inhibit glucocorticoid activation and the other half will be given a placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Leeds
• Treatments: Niacinamide

Criteria

Inclusion Criteria:

1. Able and willing to consent

2. Type 2 diabetes with HbA1c ≤11% (≤97 mmol/mol) at screening while taking standard therapy at a stable dose for ≥10 weeks

Exclusion Criteria:

1. Women of child-bearing potential

2. Active leg/foot ulceration

3. Clinically relevant acute electrocardiogram anomalies

4. Uncontrolled hypertension

5. Endocrine disorder (other than type 2 diabetes ), including type 1 or secondary diabetes (except treated hypothyroidism)

6. Gilbert's disease

7. Alanine aminotransferase and/or aspartate aminotransferase and/or alkaline phosphatase >1.5x upper limit of normal (ULN)

8. Bilirubin >1.5x ULN

9. Estimated glomerular filtration rate <45 ml/min/m2

10. Creatine kinase >2x ULN

11. Drug abuse within the last year

12. Any glucocorticoid treatment within 3 months of screening

13. Anti-coagulant medication

14. Probenecid therapy

15. Medical/surgical procedure or trauma during drug administration or one week after drug cessation (excluding skin biopsies)

16. Involvement in trial planning and/or conduct

17. Participation in other clinical study within 1 month

18. Deemed inappropriate to participate by the trial team