The effect of prednisolone versus hydrocortisone as glucocorticoid replacement therapy on hypoglycaemia frequency in people with Type 1 diabetes and adrenal insufficiency.

Phase 1

• Conditions: Type 1 diabetes and adrenal insufficiency.; MedDRA version: 13.1 Level: PT Classification code 10001367 Term: Adrenal insufficiency System Organ Class: 10014698 - Endocrine disorders; MedDRA version: 13.1 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2008-002336-15-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-25
• Study Completion: 2017-09-20
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 3

Inclusion Criteria

1. Able to provide informed consent to participate in the study
2. Age 18 or over
3. Type 1 diabetes.
4. On current insulin regimen for at least 4 weeks.
5. Understanding of the principles of self-adjustment of insulin regimen on the basis of self blood glucose monitoring results.
6. Adrenal insufficiency
7. On current hydrocortisone regimen for at least 2 months.
8. Normal thyroid function or on appropriate thyroxine replacement.
9. With or without problematic hypoglycaemia.

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 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

1. Inability to give informed consent
2. Age less than 18 years
3. Pregnancy or breastfeeding
4. Currently enrolled in other clinical study
5. Islet transplant / pancreatic transplant
6. Other steroid treatment (except inhalers and topical steroids)
7. Unstable angina, myocardial infarction, uncontrolled congestive cardiac failure in the previous year
8. Recent history of cancer (<5years)
9. Chronic kidney disease ( stage 3-5)
10. Liver function tests more than 3 times the upper limit of normal.
11. Coagulopathy (INR>1.5 or platelets less than 50x109/L)
12. Anaemia (Hb less than 10g/dL, except stable haemoglobinopathy)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified