Efficacy and Safety of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes
Overview[ - collapse ][ - ]
Purpose | 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). |
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Condition | Diabetes Diabetes Mellitus, Type 2 |
Intervention | Drug: rosiglitazone Drug: inhaled human insulin Drug: metformin |
Phase | Phase 3 |
Sponsor | Novo Nordisk A/S |
Responsible Party | Novo Nordisk A/S |
ClinicalTrials.gov Identifier | NCT00348712 |
First Received | July 5, 2006 |
Last Updated | July 9, 2012 |
Last verified | July 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | July 5, 2006 |
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Last Updated Date | July 9, 2012 |
Start Date | October 2006 |
Estimated Primary Completion Date | March 2008 |
Current Primary Outcome Measures | Treatment difference in HbA1c [Time Frame: After 26 weeks] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Efficacy and Safety of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes |
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Official Title | Efficacy and Safety of Inhaled Pre-prandial Human Insulin Plus Metformin Versus Rosiglitazone Plus Metformin in Type 2 Diabetes |
Brief Summary | 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). |
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: rosiglitazone Tablets, 4 mg once or twice daily. Drug: inhaled human insulin Treat-to-target dose titration scheme, inhalation. Other Names: NN1998Drug: metformin Tablets, 2000 mg/day. |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Terminated |
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Estimated Enrollment | 301 |
Estimated Completion Date | March 2008 |
Estimated Primary Completion Date | March 2008 |
Eligibility Criteria | Inclusion Criteria: - Type 2 diabetes - Treated with OAD(s) for more than or equal to 2 months - Body mass index of (BMI) less than or equal to 40.0 kg/m2 - HbA1c greater than or equal to 7.5% and less than or equal to 11.0 % for subjects in OAD monotherapy and HbA1c greater than or equal to 7.0% 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 disorders - Uncontrolled hypertension - Proliferative retinopathy or maculopathy |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Austria, Finland, France, Germany, Ireland, Netherlands, Spain, Switzerland, United Kingdom |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00348712 |
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Other Study ID Numbers | NN1998-1390 |
Has Data Monitoring Committee | No |
Information Provided By | Novo Nordisk A/S |
Study Sponsor | Novo Nordisk A/S |
Collaborators | Not Provided |
Investigators | Study Director: Gitte S. Fuchs, BSc Novo Nordisk A/S |
Verification Date | July 2012 |
Locations[ + expand ][ + ]
Austria | Vienna, Austria |
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Finland | Turku, Finland |
France | Paris, France |
Germany | Flörsheim, Germany |
Ireland | Dublin, Ireland |
Netherlands | Den Haag, Netherlands |
Spain | San Juan de Alicante (Alicante), Spain |
Switzerland | Zürich, Switzerland |
United Kingdom | Swansea, United Kingdom |