Continuous Subcutaneous Hydrocortisone Infusion In Addison`s Disease and Type 1 Diabetes

This study is currently recruiting participants.
Verified November 2013 by Haukeland University Hospital
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01840189
First received: April 23, 2013
Last updated: November 29, 2013
Last verified: November 2013
  Purpose

The conventional glucocorticoid replacement therapy in primary adrenal insufficiency (Addison's disease) renders the cortisol levels unphysiological, which may cause symptoms and long-term complications.

The majority of Addison's patients have other organ-specific autoimmune disease, which poses challenges to the replacement therapy. Of particular interest is the combination of Addison`s disease and type 1 diabetes, since cortisol affects glucose homeostasis. The clinical experience is that this subgroup of patients is difficult to treat, but very little research has been done to understand and improve their situation.

Glucocorticoid replacement is technically feasible by continuous subcutaneous hydrocortisone infusion, and can mimic the normal diurnal cortisol rhythm. This pilot study aims to further evaluate continuous subcutaneous hydrocortisone infusion treatment in terms of metabolic effects especially glycemic control in patients with the combination of Addison`s disease and type 1 diabetes in an 5 months cross-over design open clinical pilot study.


Condition Intervention Phase
Addison Disease
Type 1 Diabetes
Other: Cortef
Other: Solu-cortef
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Continuous Subcutaneous Hydrocortisone Infusion In Addison`s Disease and Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • nocturnal hypoglycemic events [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    severe hypoglycemia (needs for another person's assistance, blood glucose ≤ 3.1 mmol ⁄ L or prompt recovery after oral carbohydrate, i.v glucose or glucagon administration) and insulin requirement


Secondary Outcome Measures:
  • o Nocturnal glycemic variability [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    monitored by continuous glucose monitor system

  • hormone and metabolic profile [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    • Hormone levels : insulin like growth factor 1, growth hormone
    • Steroid metabolism: adrenocorticotropic hormone , cortisol
    • Metabolic profile: fructosamine, HBA1C, lipid levels, C reactive protein , homeostasis model assessment index

  • o Subjective health status [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Self administration of questionnaires


Estimated Enrollment: 10
Study Start Date: May 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cortef
Treatment A is oral hydrocortisone replacement( Cortef 5 mg)with weight-adjusted doses as suggested by Mah et al , will take 2 months
Other: Solu-cortef

Treatment B is continuous subcutaneous hydrocortisone infusion with the initial standard dose of 10mg/m2/24hrs. Body surface area will be calculated according to the nomogram from the formula of Du Bois and Du Bois.

This part of the study will take 2 months.

Active Comparator: Solu-cortef
This is the treatment B by continuous subcutaneous hydrocortisone infusion. Solu-cortef infusion will be given as Solu-Cortef Act-o-Vial 50mg/ml, , produced by Pfizer. Pump designed for subcutaneous insulin infusion can be used for subcutaneous administration.
Other: Cortef
Treatment A is oral hydrocortisone replacement ( Cortef 5 mg) administered according to weight-adjusted doses for 2 months

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- primary Addison`s disease in combination with long-standing Type 1 diabetes

Exclusion Criteria:

  • cardiovascular disease
  • active malignant disease
  • pregnant women
  • pharmacological treatment with glucocorticoids or drugs that interfere with cortisol metabolism (antiepileptics, rifampicin, St. Johns war, estrogens)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01840189

Contacts
Contact: Katerina Simunkova, MD, Phd +4755 974603 katerina.simunkova@med.uib.no

Locations
Norway
Haukeland University Hospiatl Recruiting
Bergen, Norway, 5021
Contact: Katerina Simunkova, MD, PhD       katerina.simunkova@med.uib.no   
Sub-Investigator: Kristian Løvås, MD, PhD         
Principal Investigator: Katerina Simunkova, MD, PhD         
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Study Director: Kristian Løvås, MD, PhD Haukeland University Hospital
Principal Investigator: Katerina Simunkova, PhD Haukeland University Hospital
  More Information

Additional Information:
Publications:

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01840189     History of Changes
Other Study ID Numbers: 2012/2218, 2012/005516-26
Study First Received: April 23, 2013
Last Updated: November 29, 2013
Health Authority: Norway: Norwegian Medicines Agency
Norway: Regional Ethics Commitee

Keywords provided by Haukeland University Hospital:
Addison disease
Type 1 diabetes
treatment

Additional relevant MeSH terms:
Addison Disease
Diabetes Mellitus
Diabetes Mellitus, Type 1
Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on April 23, 2014