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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
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 1
Drug: diazoxide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of 6 Months Treatment With Diazoxide at Bedtime in Preventing Beta-cell Demise in Newly Diagnosed Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Grill, Valdemar, M.D.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 40
Study Start Date: February 2005
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131755

Locations
Norway
University Hospital of Trondheim
Trondheim, Norway, 7006
Sponsors and Collaborators
Grill, Valdemar, M.D.
Investigators
Principal Investigator: Grill Valdemar, MD PhD Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Valdemar Grill, NTNU
ClinicalTrials.gov Identifier: NCT00131755     History of Changes
Other Study ID Numbers: DIAZ 1, Eudract 2004-004103-38
Study First Received: August 17, 2005
Last Updated: July 15, 2011
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Grill, Valdemar, M.D.:
type 1 diabetes
beta cell rest
diazoxide
insulin secretion

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Diazoxide
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 25, 2014