Efficacy and Safety of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT00348712|
Recruitment Status : Terminated (See termination reason in detailed description)
First Posted : July 6, 2006
Last Update Posted : March 1, 2017
This trial is conducted in Europe.
The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to metformin compared to adding rosiglitazone to metformin for the treatment of type 2 diabetes and to verify its safety (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Diabetes Mellitus, Type 2||Drug: rosiglitazone Drug: inhaled human insulin Drug: metformin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||301 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Inhaled Pre-prandial Human Insulin Plus Metformin Versus Rosiglitazone Plus Metformin in Type 2 Diabetes|
|Actual Study Start Date :||October 30, 2006|
|Actual Primary Completion Date :||March 5, 2008|
|Actual Study Completion Date :||March 5, 2008|
|Active Comparator: A||
Drug: inhaled human insulin
Treat-to-target dose titration scheme, inhalation.
Other Name: NN1998Drug: metformin
Tablets, 2000 mg/day.
|Active Comparator: B||
Tablets, 4 mg once or twice daily.Drug: metformin
Tablets, 2000 mg/day.
- Treatment difference in HbA1c [ Time Frame: After 26 weeks ]
- Adverse events [ Time Frame: For the duration of the trial ]
- Body weight [ Time Frame: For the duration of the trial ]
- Lung function [ Time Frame: For the duration of the trial ]
- Blood glucose [ Time Frame: For the duration of the trial ]
- Hypoglycaemia [ Time Frame: For the duration of the trial ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348712
Show 74 Study Locations
|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|