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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Respiratory 0 0 0 0
Asthma
Metabolic and Endocrine 0 0 0 0
Diabetes

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
Sex
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
30/08/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/02/2008
Sample size
Target
Accrual to date
Final
10
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/ct2/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/ct2/show/NCT00523042