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Efficacy of Diazoxide in Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Grill, Valdemar, M.D.
ClinicalTrials.gov Identifier:
NCT00131755
First received: August 17, 2005
Last updated: July 15, 2011
Last verified: July 2011

August 17, 2005
July 15, 2011
February 2005
August 2008   (final data collection date for primary outcome measure)
  • Insulin secretion (measured by fasting and stimulated c-peptide) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Glycemic control (measured by blood glucose) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Insulin secretion (measured by fasting and stimulated c-peptide);
  • Glycemic control (measured by blood glucose)
Complete list of historical versions of study NCT00131755 on ClinicalTrials.gov Archive Site
  • Autoimmune activity (measured by islet antibodies) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Side effects [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Autoimmune activity (measures by islet antibodies)
  • Side effects
Not Provided
Not Provided
 
Efficacy of Diazoxide in Type 1 Diabetes
Efficacy of 6 Months Treatment With Diazoxide at Bedtime in Preventing Beta-cell Demise in Newly Diagnosed Type 1 Diabetes

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

At the time of diagnosis most subjects with type 1 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. The researchers 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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 1
Drug: diazoxide
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
August 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00131755
DIAZ 1, Eudract 2004-004103-38
No
Valdemar Grill, NTNU
Grill, Valdemar, M.D.
Not Provided
Principal Investigator: Grill Valdemar, MD PhD Norwegian University of Science and Technology
Grill, Valdemar, M.D.
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP