Efficacy of Diazoxide in Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Efficacy of 6 Months Treatment With Diazoxide at Bedtime in Preventing Beta-cell Demise in Newly Diagnosed Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00131755
• Other study ID #: DIAZ 1
• Secondary ID: Eudract 2004-004
• Status: Completed
• Phase: Phase 4
• First received: August 17, 2005
• Last updated: July 15, 2011
• Start date: February 2005
• Est. completion date: August 2008

Study information

• Verified date: July 2011
• Source: Grill, Valdemar, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Drug:
• diazoxide

Locations

Country	Name	City	State
Norway	University Hospital of Trondheim	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Grill, Valdemar, M.D.

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin secretion (measured by fasting and stimulated c-peptide)		12 months	Yes
Primary	Glycemic control (measured by blood glucose)		12 months	Yes
Secondary	Autoimmune activity (measured by islet antibodies)		6 months	No
Secondary	Side effects		12 months	Yes