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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00523042




Registration number
NCT00523042
Ethics application status
Date submitted
29/08/2007
Date registered
30/08/2007
Date last updated
5/09/2018

Titles & IDs
Public title
Safety of Inhaled Preprandial Human Insulin in Subjects With Diabetes and Asthma
Scientific title
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
Secondary ID [1] 0 0
NN1998-1616
Universal Trial Number (UTN)
Trial acronym
iINHALE 9
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Diabetes Mellitus, Type 1 0 0
Diabetes Mellitus, Type 2 0 0
Asthma 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - insulin aspart
Treatment: Drugs - inhaled human insulin

Experimental: A -

Active Comparator: B -


Treatment: Drugs: insulin aspart
Treat-to-target dose titration scheme, injection s.c.

Treatment: Drugs: inhaled human insulin
Treat-to-target dose titration scheme, inhalation.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Changes in lung function, chest X-rays, or asthma exacerbation frequency
Timepoint [1] 0 0
after 52 weeks of treatment
Secondary outcome [1] 0 0
Diabetes control measured by change in HbA1c
Timepoint [1] 0 0
from baseline to end of treatment
Secondary outcome [2] 0 0
Laboratory assessments (biochemistry, insulin antibodies, blood count)
Timepoint [2] 0 0
from baseline to end of treatment
Secondary outcome [3] 0 0
Preprandial insulin doses
Timepoint [3] 0 0
for the duration of the trial

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Broadmeadow
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Camperdown
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Keswick
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Box Hill
Recruitment hospital [5] 0 0
Novo Nordisk Investigational Site - East Ringwood
Recruitment hospital [6] 0 0
Novo Nordisk Investigational Site - Parkville
Recruitment hospital [7] 0 0
Novo Nordisk Investigational Site - Auchenflower
Recruitment hospital [8] 0 0
Novo Nordisk Investigational Site - Kippa Ring
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
5035 - Keswick
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3135 - East Ringwood
Recruitment postcode(s) [6] 0 0
3052 - Parkville
Recruitment postcode(s) [7] 0 0
4066 - Auchenflower
Recruitment postcode(s) [8] 0 0
4021 - Kippa Ring
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Louisiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Utah
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Former Serbia and Montenegro
State/province [9] 0 0
Belgrade
Country [10] 0 0
India
State/province [10] 0 0
Punjab
Country [11] 0 0
India
State/province [11] 0 0
Tamil Nadu
Country [12] 0 0
India
State/province [12] 0 0
West Bengal
Country [13] 0 0
India
State/province [13] 0 0
Hyderabad
Country [14] 0 0
India
State/province [14] 0 0
Mumbai
Country [15] 0 0
India
State/province [15] 0 0
Pune
Country [16] 0 0
Malaysia
State/province [16] 0 0
Cheras
Country [17] 0 0
Malaysia
State/province [17] 0 0
Kota Bharu, Kelantan
Country [18] 0 0
Malaysia
State/province [18] 0 0
Pulau Pinang
Country [19] 0 0
Slovakia
State/province [19] 0 0
Kosice
Country [20] 0 0
Slovakia
State/province [20] 0 0
Lubochna
Country [21] 0 0
Slovakia
State/province [21] 0 0
Moldava nad Bodvou
Country [22] 0 0
Slovakia
State/province [22] 0 0
Zilina

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT00523042
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Registry (GCR, 1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00523042