Efficacy and Safety of Inhaled Insulin Compared to Metformin and Glimepiride in Type 2 Diabetes
Overview[ - collapse ][ - ]
| Purpose | This trial is conducted in Europe, Asia, North America and South America. The aim of this research trial is to compare the efficacy of inhaled insulin to glimepiride and metformin combination therapy in treatment of subjects with type 2 diabetes and to verify the safety of use (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects). |
|---|---|
| Condition | Diabetes Diabetes Mellitus, Type 2 |
| Intervention | Drug: inhaled human insulin Drug: metformin Drug: glimepiride Drug: inhaled human insulin |
| Phase | Phase 3 |
| Sponsor | Novo Nordisk A/S |
| Responsible Party | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier | NCT00469586 |
| First Received | May 3, 2007 |
| Last Updated | July 9, 2012 |
| Last verified | July 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 3, 2007 |
|---|---|
| Last Updated Date | July 9, 2012 |
| Start Date | April 2007 |
| Estimated Primary Completion Date | April 2008 |
| Current Primary Outcome Measures | HbA1c change from baseline [Time Frame: After 18 weeks of treatment] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Efficacy and Safety of Inhaled Insulin Compared to Metformin and Glimepiride in Type 2 Diabetes |
|---|---|
| Official Title | Efficacy and Safety of Inhaled Prandial Insulin Compared to Metformin Plus Glimepiride in Type 2 Diabetes |
| Brief Summary | This trial is conducted in Europe, Asia, North America and South America. The aim of this research trial is to compare the efficacy of inhaled insulin to glimepiride and metformin combination therapy in treatment of subjects with type 2 diabetes and to verify the safety of use (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects). |
| Detailed Description | The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices. |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition |
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| Intervention | Drug: inhaled human insulin Treat-to-target dose titration scheme, pre-prandial, inhalation. Other Names: NN1998Drug: metformin Tablets, 2000 mg/day. Drug: glimepiride Tablets, 4 mg/day. Drug: inhaled human insulin Treat-to-target dose titration scheme, post-prandial, inhalation. Other Names: NN1998 |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Terminated |
|---|---|
| Estimated Enrollment | 174 |
| Estimated Completion Date | April 2008 |
| Estimated Primary Completion Date | April 2008 |
| Eligibility Criteria | Inclusion Criteria: - Type 2 diabetes - Treated with OADs for more than or equal to 3 months - HbA1c greater than or equal to 8.0% and less than or equal to 11.0% - Body Mass Index (BMI) less than or equal to 40.0 kg/m2 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Argentina, Austria, Belgium, Bulgaria, Canada, France, India, Israel, Mexico, Poland, Turkey |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00469586 |
|---|---|
| Other Study ID Numbers | NN1998-1787 |
| Has Data Monitoring Committee | No |
| Information Provided By | Novo Nordisk A/S |
| Study Sponsor | Novo Nordisk A/S |
| Collaborators | Not Provided |
| Investigators | Study Director: Dorthe Lyngsoe Vuylsteke Novo Nordisk A/S |
| Verification Date | July 2012 |
Locations[ + expand ][ + ]
| Argentina | Buenos Aires, Argentina |
|---|---|
| Austria | Vienna, Austria |
| Belgium | Leuven, Belgium |
| Bulgaria | Sofia, Bulgaria |
| Canada | Edmonton, Canada |
| France | Narbonne, France |
| India | Hyderabad, India |
| Israel | Beer Sheva, Israel |
| Mexico | Mexico City, Mexico |
| Poland | Gdansk, Poland |
| Turkey | Istanbul, Turkey |