Efficacy and Safety of Inhaled Insulin Compared to Metformin and Glimepiride in Type 2 Diabetes (iINHALE 7)
This study has been terminated.
(See termination reason in detailed description)
Sponsor:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00469586
First received: May 3, 2007
Last updated: July 9, 2012
Last verified: July 2012
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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 | Intervention | Phase |
|---|---|---|
|
Diabetes Diabetes Mellitus, Type 2 |
Drug: inhaled human insulin Drug: metformin Drug: glimepiride |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficacy and Safety of Inhaled Prandial Insulin Compared to Metformin Plus Glimepiride in Type 2 Diabetes |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- HbA1c change from baseline [ Time Frame: After 18 weeks of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Adverse events [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
- Body weight [ Time Frame: after 18 weeks of treatment ] [ Designated as safety issue: No ]
- Lung function [ Time Frame: after 18 weeks of treatment ] [ Designated as safety issue: No ]
- Blood glucose [ Time Frame: after 18 weeks of treatment ] [ Designated as safety issue: No ]
- Hypoglycaemia [ Time Frame: after 18 weeks of treatment ] [ Designated as safety issue: No ]
| Enrollment: | 174 |
| Study Start Date: | April 2007 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: inhaled human insulin
Treat-to-target dose titration scheme, pre-prandial, inhalation.
Other Name: NN1998
|
| Experimental: B |
Drug: inhaled human insulin
Treat-to-target dose titration scheme, post-prandial, inhalation.
Other Name: NN1998
|
| Active Comparator: C |
Drug: metformin
Tablets, 2000 mg/day.
Drug: glimepiride
Tablets, 4 mg/day.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00469586
Locations
| 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 | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Dorthe Lyngsoe Vuylsteke | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| ClinicalTrials.gov Identifier: | NCT00469586 History of Changes |
| Other Study ID Numbers: | NN1998-1787, 2006-004623-12 |
| Study First Received: | May 3, 2007 |
| Last Updated: | July 9, 2012 |
| Health Authority: | Mexico: Federal Commission for Protection Against Health Risks Turkey: Ministry of Health Drug and Pharmaceutical Department Canada: Health Canada India: Ministry of Health Bulgaria: Bulgarian Drug Agency Austria: Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH Israel: Israeli Health Ministry Pharmaceutical Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia France: Agence du Médicament Poland: National Medicines Institute Belgium: FPS of Public Health, Directorate General for the protection of Public Health: Medicines |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glimepiride Insulin Metformin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013