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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00343980




Registration number
NCT00343980
Ethics application status
Date submitted
22/06/2006
Date registered
23/06/2006
Date last updated
1/03/2017

Titles & IDs
Public title
Safety and Efficacy of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes
Scientific title
Safety and Efficacy of Inhaled Pre-prandial Human Insulin Plus Glimepiride Versus Rosiglitazone Plus Glimepiride in Type 2 Diabetes
Secondary ID [1] 0 0
NN1998-1682
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

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

Experimental: A -

Active comparator: B -


Treatment: Drugs: rosiglitazone
Tablets, 4 mg once or twice a day.

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

Treatment: Drugs: glimepiride
Tablets, 4 mg/day.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment difference in HbA1c
Timepoint [1] 0 0
After 26 weeks
Secondary outcome [1] 0 0
Adverse events
Timepoint [1] 0 0
For the duration of the trial
Secondary outcome [2] 0 0
Body weight
Timepoint [2] 0 0
during treatment
Secondary outcome [3] 0 0
Lung function
Timepoint [3] 0 0
after 26 weeks of treatment
Secondary outcome [4] 0 0
Blood glucose
Timepoint [4] 0 0
after 26 weeks of treatment
Secondary outcome [5] 0 0
Hypoglycaemia
Timepoint [5] 0 0
from 12-26 weeks of treatment

Eligibility
Key inclusion criteria
* Type 2 diabetes
* Treated with OAD(s) for more than or equal to 2 months
* Body mass index (BMI) less than or equal to 40.0 kg/m2
* HbA1c greater than or equal to 8.0 % and less than or equal to 11.0 % for subjects in OAD monotherapy
* HbA1c greater than or equal to 7.5 % and less than or equal to 10.0 % for subjects on OAD combination therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Recurrent major hypoglycaemia
* Current smoking or smoking within the last 6 months
* Impaired hepatic or renal function
* Cardiac problems
* Uncontrolled hypertension
* 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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/10/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/03/2008
Sample size
Target
Accrual to date
Final
363
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - St Leonards
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Wollongong
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Garran
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Kingswood
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
2605 - Garran
Recruitment postcode(s) [4] 0 0
2747 - Kingswood
Recruitment outside Australia
Country [1] 0 0
Croatia
State/province [1] 0 0
Osijek
Country [2] 0 0
Croatia
State/province [2] 0 0
Zagreb
Country [3] 0 0
India
State/province [3] 0 0
Tamil Nadu
Country [4] 0 0
India
State/province [4] 0 0
Bangalore
Country [5] 0 0
India
State/province [5] 0 0
Chennai
Country [6] 0 0
India
State/province [6] 0 0
Coimbatore
Country [7] 0 0
Macedonia, The Former Yugoslav Republic of
State/province [7] 0 0
Skopje
Country [8] 0 0
Philippines
State/province [8] 0 0
Cebu City
Country [9] 0 0
Philippines
State/province [9] 0 0
Makati City
Country [10] 0 0
Philippines
State/province [10] 0 0
Manila
Country [11] 0 0
Russian Federation
State/province [11] 0 0
Moscow
Country [12] 0 0
Russian Federation
State/province [12] 0 0
Saint-Petersburg
Country [13] 0 0
Turkey
State/province [13] 0 0
Bornova-IZMIR
Country [14] 0 0
Turkey
State/province [14] 0 0
Bursa
Country [15] 0 0
Turkey
State/province [15] 0 0
Istanbul

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/NCT00343980