Diazoxide Injection |
Hyperstat IV |
Clinical Trial: Efficacy of Diazoxide in Type 1 Diabetes
This study is currently recruiting patients.
Verified by Grill, Valdemar, M.D. August 2005
|
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Diabetes Mellitus, Type 1 | Drug: diazoxide | Phase IV |
MedlinePlus related topics: Juvenile Diabetes
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Efficacy of 6 Months Trestment with Diazoxide at Bedtime in Preventing Beta-Cell Demise in Newly Diagnosted Type 1 Diabetes
Secondary Outcomes: Autoimmune activity (measures by islet antibodies); Side effects
Expected Total Enrollment: 35
Study start: February 2005; Expected completion: January 2008
At the time of diagnosis most subjects with type1 diabetes retain significant endogenous insulin secretion as assessed by C-peptide measurements. Although not sufficient for the needs of the individual, residual insulin secretion is important for metabolic control, for avoidance of hypoglycemic episodes and, perhaps, for protection against diabetic complications. To retain residual endogenous insulin secretion in type 1 diabetes is thus highly desirable.
Residual insulin secretion deteriorates during the course of type 1 diabetes. The underlying autoimmune process is a major determinant of deterioration.
However, also measures that do not directly target the immune system could be beneficial. The DCCT study randomised subjects with type 1 diabetes to either intensive or conventional insulin treatment. The intensive insulin treatment markedly retarded deterioration in C-peptide levels during 5 years of observation. The favourable effect could be due to lesser hyperglycemia per se. Alternatively, the effect of intensive insulin treatment could be secondary to lesser degree of over-stimulation of the patients’ beta-cells.
It is by now established that relief from over-stimulation by diazoxide favourably affects beta-cell function and that such treatment can retard a decline in residual insulin secretion in subjects with newly diagnosed type 1 diabetes. Diazoxide has been used in clinical practice for > three decades without major safety concerns.
Disturbing, albeit reversible, side effects are halting long-term studies with diazoxide in type 1 diabetes. We find that lower and intermittent (i.e. night time) dosing of diazoxide produces no measurable side effects in subjects with type 2 diabetes.
This is a double blinded placebo controlled study, with 35 participants with newly diagnosed type 1 diabetes are randomised into either placebo or Diazoxide for 6 months. The patients will be followed up after intervention for at least 12 months.
Beta cell function and glycemic control will be monitored.
Eligibility
Inclusion Criteria:
- type 1 diabetes no longer than three months
- positive antibodies against GAD or IA2
- age between 18-40 years
- c-peptide >0.2 nmol/l
Exclusion Criteria:
- drug- or alcohol abuse
- severe concomitant disease
- pregnancy
Location and Contact Information
Maria Radtke, MD +47 73868519 maria.radtke@ntnu.no
Norway
University Hospital of Trondheim, Trondheim, 7006, Norway; Recruiting
Maria Radtke, MD maria.radtke@ntnu.no
Grill Valdemar, MD PhD, Principal Investigator, Norwegian University of science and technology
More Information
Last Updated: August 18, 2005
Record first received: August 17, 2005
ClinicalTrials.gov Identifier: NCT00131755
Health Authority: Norway: Norwegian Medicines Agency
ClinicalTrials.gov processed this record on 2005-08-23
Resources
- Diazoxide Injection (Drug Digest)
- Hyperstat IV (Drug Digest)

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