NCT00523042|TerminatedPhase 3

Study Stopped

See termination reason in detailed description

Safety of Inhaled Preprandial Human Insulin in Subjects With Diabetes and Asthma

iINHALE 9

Inhaled Preprandial Human Insulin With the AERx® iMS Versus Subcutaneous Injected Insulin Aspart in Subjects With Diabetes and Asthma: A 52-week, Open-label, Multinational, Randomised, Parallel Trial to Investigate Long-term Safety

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

NN1998-1616

Study Type

interventional

Target

Locations

6 countries

Sites

Timeline

RegisteredAug 2007

StartedAug 2007

CompletionFeb 2008

Brief Summary

This trial is conducted in Europe, Asia, Oceania and the United States of America (USA). This is a one-year clinical trial to compare the safety of inhaled preprandial human insulin to subcutaneous insulin aspart in subjects with type 1 or 2 diabetes and asthma.

Trial Health

Monitor

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for phase_3 diabetes

Timeline

Completed

Started Aug 2007

Shorter than P25 for phase_3 diabetes

Geographic Reach

6 countries

32 active sites

Status

terminated

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

6 months study duration

First Submitted

Initial submission to the registry

August 29, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2007

Completed

Same day until next milestone

Study Start

First participant enrolled

August 30, 2007

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2008

Completed

Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

6 months

First QC Date

August 29, 2007

Last Update Submit

September 3, 2018

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Asthma

Outcome Measures

Primary Outcomes (1)

Changes in lung function, chest X-rays, or asthma exacerbation frequency
after 52 weeks of treatment

Secondary Outcomes (3)

Diabetes control measured by change in HbA1c
from baseline to end of treatment
Laboratory assessments (biochemistry, insulin antibodies, blood count)
from baseline to end of treatment
Preprandial insulin doses
for the duration of the trial

Study Arms (2)

A

EXPERIMENTAL

Drug: inhaled human insulin

B

ACTIVE COMPARATOR

Drug: insulin aspart

Interventions

insulin aspartDRUG

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

Also known as: NovoRapid®, NovoLog®

inhaled human insulinDRUG

Treat-to-target dose titration scheme, inhalation.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 1 or type 2 diabetes
Treatment with insulin and/or oral anti-diabetic drugs
Asthma for at least 6 months
Positive airway reversibility/bronchoprovocation test or documented positive test in the last 3 years
HbA1C less than or equal to 11.0 %
Body Mass Index (BMI) less than or equal to 40.0 kg/m2

You may not qualify if:

Current smoking or smoking within the last 6 months
Other current acute or chronic pulmonary disease excluding asthma
Recurrent severe hypoglycaemia
Proliferative retinopathy or maculopathy

Contact the study team to confirm eligibility.