NCT00322257|TerminatedPhase 3

Study Stopped

See termination reason in detailed description

Safety and Efficacy of Inhaled Insulin in Type 1 Diabetes

Inhaled Mealtime Insulin With the AERx® iDMS Versus Subcutaneous Injected Insulin Aspart Both in Combination With Insulin Detemir in Type 1 Diabetes: A 104 Week, Open-Label, Multicenter, Randomised, Parallel Trial (Followed by a Twelve-Week Re-Randomised Extension) To Investigate Safety and Efficacy

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

NN1998-2076

Study Type

interventional

Target

596

Locations

2 countries

Sites

Timeline

RegisteredMay 2006

StartedMay 2006

CompletionApr 2008

Brief Summary

This trial is conducted in the United States of America (USA) and Canada. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin determir in Type 1 Diabetes.

Trial Health

Monitor

Trial Health Score

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

Enrollment

596

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started May 2006

Typical duration for phase_3 diabetes

Geographic Reach

2 countries

96 active sites

Status

terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

1.9 years study duration

Study Start

First participant enrolled

May 1, 2006

Completed

2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2006

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2008

Completed

Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

1.9 years

First QC Date

May 3, 2006

Last Update Submit

September 3, 2018

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

HbA1c
After 52 weeks

Secondary Outcomes (6)

Body weight
after 52 weeks
Antibodies
after 52 weeks
Hypoglycemia
For the duration of the trial
Insulin doses
For the duration of the trial
Pulmonary Function
For the duration of the trial
+1 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

Drug: inhaled human insulinDrug: insulin detemir

B

ACTIVE COMPARATOR

Drug: insulin detemirDrug: insulin aspart

Interventions

inhaled human insulinDRUG

Treat-to-target dose titration scheme, inhalation.

insulin detemirDRUG

Injection s.c., 50% of daily dose

Also known as: Levemir, NN304

insulin aspartDRUG

Treat-to-target dose titration scheme, injection s.c.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Type 1 diabetes
HbA1c less than or equal to 11%
Body mass index (BMI) less than or equal to 40.0 kg/m2

You may not qualify if:

Total daily insulin dosage more than 100 IU or U/day.
Current smoking or smoking within the last 6 months
Impaired hepatic or renal function
Cardiac problems
Uncontrolled hypertension
Current proliferative retinopathy or maculopathy requiring acute treatment

Contact the study team to confirm eligibility.