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Efficacy of Diazoxide in Type 1 Diabetes - Article


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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

Sponsored by: Grill, Valdemar, M.D.
Information provided by: Grill, Valdemar, M.D.
ClinicalTrials.gov Identifier: NCT00131755

Purpose

The purpose of this study is to find out if Diazoxide can partly retain insulin production in newly diagnosed type 1 diabetes
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

Further Study Details: 
Primary Outcomes: Insulin secretion (measured by fasting and stimulated c-peptide);; Glycemic control (measured by blood glucose)
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

Ages Eligible for Study:  18 Years   -   40 Years,  Genders Eligible for Study:  Both
Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00131755

Grill Valdemar, MD, PhD      +47 73868000    valdemar.grill@ntnu.no
Maria Radtke, MD      +47 73868519    maria.radtke@ntnu.no

Norway
      University Hospital of Trondheim, Trondheim,  7006,  Norway; Recruiting
Valdemar Grill, MDPhD   valdemar.grill@ntnu.no 
Maria Radtke, MD   maria.radtke@ntnu.no 

Study chairs or principal investigators

Grill Valdemar, MD PhD,  Principal Investigator,  Norwegian University of science and technology   

More Information

Study ID Numbers:  DIAZ 1; Eudract 2004-004103-38
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

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Page Updated: June 1, 2005
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