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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/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
Terminated
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
This trial is conducted in Asia, Europe and Oceania. The aim of this research study is to
compare the efficacy of adding inhaled preprandial insulin to glimepiride compared to adding
rosiglitazone to glimepiride for the treatment of type 2 diabetes and to verify its safety
(hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects)
Trial website
https://clinicaltrials.gov/ct2/show/NCT00343980
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/NCT00343980