|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT00343980 |
|
Date of registration:
|
22/06/2006 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
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 |
|
Date of first enrolment:
|
October 10, 2006 |
|
Target sample size:
|
363 |
|
Recruitment status: |
Terminated |
|
URL:
|
https://clinicaltrials.gov/show/NCT00343980 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Australia
|
Croatia
|
India
|
Macedonia, The Former Yugoslav Republic of
|
Philippines
|
Russian Federation
|
Turkey
| |
|
Contacts
|
|
Name:
|
Global Clinical Registry (GCR, 1452) |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Novo Nordisk A/S |
| | |
|
Key inclusion & exclusion criteria
|
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
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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Diabetes
|
|
Diabetes Mellitus, Type 2
|
|
Intervention(s)
|
|
Drug: glimepiride
|
|
Drug: inhaled human insulin
|
|
Drug: rosiglitazone
|
|
Primary Outcome(s)
|
|
Treatment difference in HbA1c
[Time Frame: After 26 weeks]
|
|
Secondary Outcome(s)
|
|
Body weight
[Time Frame: during treatment]
|
|
Lung function
[Time Frame: after 26 weeks of treatment]
|
|
Adverse events
[Time Frame: For the duration of the trial]
|
|
Blood glucose
[Time Frame: after 26 weeks of treatment]
|
|
Hypoglycaemia
[Time Frame: from 12-26 weeks of treatment]
|
|
Secondary ID(s)
|
|
NN1998-1682
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|