NCT00131755

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

July 18, 2011

Status Verified

July 1, 2011

Enrollment Period

3.5 years

First QC Date

August 17, 2005

Last Update Submit

July 15, 2011

Conditions

Diabetes Mellitus, Type 1

Keywords

type 1 diabetesbeta cell restdiazoxideinsulin secretion

Outcome Measures

Primary Outcomes (2)

  • Insulin secretion (measured by fasting and stimulated c-peptide)

    12 months

  • Glycemic control (measured by blood glucose)

    12 months

Secondary Outcomes (2)

  • Autoimmune activity (measured by islet antibodies)

    6 months

  • Side effects

    12 months

Interventions

diazoxideDRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Drug or alcohol abuse
  • Severe concomitant disease
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Trondheim

Trondheim, 7006, Norway

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Diazoxide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

BenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Grill Valdemar, MD PhD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV

Study Record Dates

First Submitted

August 17, 2005

First Posted

August 19, 2005

Study Start

February 1, 2005

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

July 18, 2011

Record last verified: 2011-07

Locations

NO(1)