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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00725036




Registration number
NCT00725036
Ethics application status
Date submitted
29/07/2008
Date registered
30/07/2008
Date last updated
1/03/2017

Titles & IDs
Public title
Long Term Safety Trial to Compare Insulin Treatment With Preprandial Inhaled Human Insulin to s.c. Insulin Aspart Both Combined With NPH in Subjects With Type 1 Diabetes
Scientific title
A 24-month Multicentre, Open-label, Randomised, Parallel Group, Long Term Safety Trial Comparing Intensive Treatment of Pulmonary Inhaled Human Insulin With Insulin Aspart Administered s.c., Both in Combination With NPH, in Subjects With Type 1 Diabetes
Secondary ID [1] 0 0
NN1998-1496
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Long term pulmonary safety profiles
Timepoint [1] 0 0
during treatment
Secondary outcome [1] 0 0
Glycaemic control as measured by HbA1c
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Incidence of hypoglycaemic episodes
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Long-term safety profiles (laboratory, ECG, insulin antibodies)
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Physical examination and body weight and vital signs
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Adverse events
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Treatment satisfaction
Timepoint [6] 0 0

Eligibility
Key inclusion criteria
* Type 1 diabetes
* Current treatment with any insulin in any regimen
* Body mass index (BMI) below 38.0 kg/m2
* HbA1c below or equal to 13.0%
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Total daily insulin dosage more than 100 IU/day
* Current acute or chronic pulmonary disease (excluding asthma)
* Recurrent major hypoglycaemia
* Proliferative retinopathy or maculopathy requiring acute treatment
* Smoker
* Chest X-ray with clinically significant abnormalities

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/09/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/12/2004
Sample size
Target
Accrual to date
Final
305
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
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 - St Leonards
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Wollongong
Recruitment hospital [5] 0 0
Novo Nordisk Investigational Site - Woolloongabba
Recruitment hospital [6] 0 0
Novo Nordisk Investigational Site - Keswick
Recruitment hospital [7] 0 0
Novo Nordisk Investigational Site - Fremantle
Recruitment hospital [8] 0 0
Novo Nordisk Investigational Site - Ashford
Recruitment hospital [9] 0 0
Novo Nordisk Investigational Site - Auckland
Recruitment hospital [10] 0 0
Novo Nordisk Investigational Site - Box Hill
Recruitment hospital [11] 0 0
Novo Nordisk Investigational Site - Christchurch
Recruitment hospital [12] 0 0
Novo Nordisk Investigational Site - Clayton
Recruitment hospital [13] 0 0
Novo Nordisk Investigational Site - Garran
Recruitment hospital [14] 0 0
Novo Nordisk Investigational Site - Heidelberg
Recruitment hospital [15] 0 0
Novo Nordisk Investigational Site - Parkville
Recruitment hospital [16] 0 0
Novo Nordisk Investigational Site - Perth
Recruitment hospital [17] 0 0
Novo Nordisk Investigational Site - Randwick
Recruitment hospital [18] 0 0
Novo Nordisk Investigational Site - Stones Corner
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
5035 - Keswick
Recruitment postcode(s) [7] 0 0
6160 - Fremantle
Recruitment postcode(s) [8] 0 0
5035 - Ashford
Recruitment postcode(s) [9] 0 0
- Auckland
Recruitment postcode(s) [10] 0 0
3128 - Box Hill
Recruitment postcode(s) [11] 0 0
- Christchurch
Recruitment postcode(s) [12] 0 0
3168 - Clayton
Recruitment postcode(s) [13] 0 0
2605 - Garran
Recruitment postcode(s) [14] 0 0
3085 - Heidelberg
Recruitment postcode(s) [15] 0 0
3050 - Parkville
Recruitment postcode(s) [16] 0 0
6000 - Perth
Recruitment postcode(s) [17] 0 0
2031 - Randwick
Recruitment postcode(s) [18] 0 0
4120 - Stones Corner

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00725036