Efficacy of Diazoxide in Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00131755
Recruitment Status : Completed
First Posted : August 19, 2005
Last Update Posted : July 18, 2011
Information provided by:
Grill, Valdemar, M.D.

August 17, 2005
August 19, 2005
July 18, 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 ]
  • Glycemic control (measured by blood glucose) [ Time Frame: 12 months ]
  • Insulin secretion (measured by fasting and stimulated c-peptide);
  • Glycemic control (measured by blood glucose)
Complete list of historical versions of study NCT00131755 on Archive Site
  • Autoimmune activity (measured by islet antibodies) [ Time Frame: 6 months ]
  • Side effects [ Time Frame: 12 months ]
  • Autoimmune activity (measures by islet antibodies)
  • Side effects
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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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 1
Drug: diazoxide
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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
Sexes Eligible for Study: All
18 Years to 40 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Eudract 2004-004103-38
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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