NCT00850161

Brief Summary

The purpose of this study is to determine if glucose peaks higher and earlier after a meal when a patient is given intranasal insulin instead of conventional insulin treatment.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_2

Status
withdrawn

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

February 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

February 15, 2016

Status Verified

February 1, 2016

Enrollment Period

1 month

First QC Date

February 23, 2009

Last Update Submit

February 12, 2016

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 DiabetesNasal InsulinInsulin DeficiencyInsulin-Dependent

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is to determine whether intranasal administration of Nasulin™ will stimulate glucose disposal and suppress endogenous glucose production.

    Blood will be measured at -30, -20, -10, 0, 2, 6, 8, 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 minutes

Study Arms (2)

Nasulin™

EXPERIMENTAL

Intranasal insulin spray

Drug: Nasulin™

aspart

ACTIVE COMPARATOR

Subcutaneous administration

Drug: aspart

Interventions

aspartDRUG

Meal-time insulin. Administered subcutaneously based on routine clinical therapy.

Also known as: insulin aspart
aspart
Nasulin™DRUG

100 IU(2 puffs in each nostril)

Also known as: insulin
Nasulin™

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of Type 1 Diabetes
  • Age 18-50
  • Treatment management of MDI(multiple daily injections) or Insulin Pump
  • BMI between 19-30 Kg/M2
  • HbA1c less than or equal to 8.0%
  • g OGTT (oral glucose tolerance test)study with insulin concentrations \>80uU/mL

You may not qualify if:

  • Active Proliferative Retinopathy
  • Active Nephropathy
  • Chronic Upper Respiratory Conditions determined by MD
  • Pregnant or Lactating Female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin AspartInsulin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsProinsulin

Study Officials

  • Adrian Vella, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2009

First Posted

February 24, 2009

Study Start

July 1, 2009

Primary Completion

August 1, 2009

Study Completion

September 1, 2010

Last Updated

February 15, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

There is no data; study never initiated.