NCT00336674

Brief Summary

In people with type 1 diabetes the beta cells of the pancreas no longer make insulin because the body's immune system has attacked and destroyed the beta cells. It is thought that exposure of the mucous membranes to insulin may cause act like a vaccine effect whereby protective immune cells are stimulated and these then counteract the "bad" immune cells that damage the beta cells. This study aims to determine if intranasal insulin can protect beta cells and stop progression to diabetes in individuals who are at risk.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2006

Longer than P75 for phase_2

Geographic Reach
2 countries

6 active sites

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

First Submitted

Initial submission to the registry

June 12, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
13 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2019

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

13 years

First QC Date

June 12, 2006

Last Update Submit

October 5, 2020

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetes

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of Diabetes AT 5 years according to American Diabetes Association / World Health Organization (ADA/WHO) criteria.

    Defined as the presence of 2 or more of the following diagnostic criteria including diabetic fasting blood glucose level, diabetic 2 hour postprandial blood glucose level, diabetic HbA1c and symptoms

    1 year of treatment 9 years follow up

Secondary Outcomes (3)

  • B cell function

    1 year of treatment 9 years follow up

  • Insulin Action

    1 year of treatment 9 years follow up

  • Immune function

    1 year of treatment 9 years follow up

Study Arms (2)

DV001

ACTIVE COMPARATOR

Recombinant human intranasal insulin formulation in a buffered solution of benzalkonium chloride and glycerol presented in multi-dose nasal spray devices with actuators (Pfeiffer) designed to deliver 100ul spray doses to nasal mucosa. The product is formulated at a dose strength of 1100 IU / mL (40mg/mL) manufacturing formulation. The product will be self administered by eligible participants as two 100 microlitre spray doses per nostril. Treatment will be administered daily for 7 consecutive days then on one day each week for 12 months. Participants will be followed until they develop diabetes or until 5 years after the last participant has been randomised (maximum period of follow up is expected to be 10 years.

Biological: Intranasal insulin

Placebo

PLACEBO COMPARATOR

Placebo insulin carrier solution of benzalkonium chloride and glycerol presented in multi-dose nasal spray devices with actuators (Pfeiffer) designed to deliver 100ul spray doses to nasal mucosa. The product will be self administered by participants as two 100 microlitre spray doses per nostril. Treatment will be administered daily for 7 consecutive days then on one day each week for 12 months. Participants will be followed until they develop diabetes or until 5 years after the last participant has been randomised (maximum period of follow up is expected to be 10 years.

Other: Placebo

Interventions

Intranasal insulinBIOLOGICAL

440IU Insulin

DV001
PlaceboOTHER

Placebo insulin carrier solution containing benzalkonium chloride and glycerol

Placebo

Eligibility Criteria

Age4 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • First-degree or second-degree relative of a person with Type 1 diabetes (T1D) diagnosed before age 40.
  • Age 4-30 years if first-degree relative; age 4-20 years if second-degree relative.
  • Confirmed serum antibodies to two or more islet antigens.
  • Normal oral glucose tolerance test (OGTT).
  • First phase insulin response (FPIR) at or above threshold - Primary Stratum - greater than or equal to 10th percentile for siblings, offspring and second-degree relatives of person with T1D (greater than or equal to 100uU/ml if aged 8 or more years OR greater than or equal to 60 uU/ml if aged less than 8) and greater than or equal to the 1st percentile for parents of someone with T1D (greater than ore equal to 60uU/ml). Secondary Stratum: Greater than or equal 1st percentile, less than 10th percentile for siblings, offspring and second-degree relatives of someone with T1D (greater than or equal to 50uU/ml less than 100 uU/ml if aged greater than or equal to 8 years or greater than or equal to 20 uU/ml less than 60uU/ml if aged less than 8 years)
  • Provision of written consent. -

You may not qualify if:

  • History of treatment with insulin or oral hypoglycemic agents
  • Known diabetes by ADA/WHO criteria
  • Pregnant or lactating or of child-bearing potential not using an adequate method of contraception
  • Concomitant disease or treatment which may interfere with assessment or cause immunosuppression, as judged by the investigators.
  • Uncorrected vitamin D deficiency
  • Known alcohol or drug abuse, psychiatric or other condition that could be associated with poor compliance.
  • Known liver disease, or persisting elevation of plasma Aspartate transaminase (AST) or Alanine transaminase (ALT) levels.
  • Impaired renal function
  • Any defect or pathology of nasal passage which would preclude application of the intranasal spray.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

The Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia

Location

Mater Children's Hospital

Brisbane, Queensland, 4101, Australia

Location

Womens and Childrens Hospital

North Adelaide, South Australia, 5006, Australia

Location

Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

Location

Princess Margaret Hospital

Subiaco, Western Australia, 6840, Australia

Location

University of Auckland

Auckland, New Zealand

Location

Related Publications (1)

  • Jacobsen LM, Schatz DA. Insulin immunotherapy for pretype 1 diabetes. Curr Opin Endocrinol Diabetes Obes. 2021 Aug 1;28(4):390-396. doi: 10.1097/MED.0000000000000648.

    PMID: 34091488DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

  • Leonard C Harrison, MBBS MD DSc

    Melbourne Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2006

First Posted

June 14, 2006

Study Start

December 1, 2006

Primary Completion

November 13, 2019

Study Completion

November 13, 2019

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

NZ(1)AU(5)