Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
This trial is conducted in Oceania.

The aim of this trial is to compare the safety of using pulmonary inhaled human insulin to s.c. insulin aspart both combined with NPH insulin in subjects with type 1 diabetes.
Trial website
https://clinicaltrials.gov/study/NCT00725036
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/study/NCT00725036