Efficacy and Safety of Inhaled Insulin Compared to Metformin and Glimepiride in Type 2 Diabetes - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00469586

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 Mellitus	Drug: inhaled human insulin Drug: metformin Drug: glimepiride	Phase III

MedlinePlus related topics: Diabetes Hypoglycemia

Drug Information available for: Insulin Glimepiride Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Inhaled Prandial Insulin Compared to Metformin Plus Glimepiride in Type 2 Diabetes

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:	170
Study Start Date:	May 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: inhaled human insulin Treat-to-target dose titration scheme, pre-prandial, inhalation.
B: Experimental	Drug: inhaled human insulin Treat-to-target dose titration scheme, post-prandial, inhalation.
C: Active Comparator	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:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN1998-1787, EudraCT No: 2006-004623-12
Study First Received:	May 3, 2007
Last Updated:	June 24, 2008
ClinicalTrials.gov Identifier:	NCT00469586 History of Changes
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; 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

Study placed in the following topic categories:

Metabolic Diseases
Immunologic Factors
Metformin
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Immunosuppressive Agents
Insulin

Glimepiride
Hypoglycemic Agents
Diabetes Mellitus, Type 2
Anti-Arrhythmia Agents
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Immunologic Factors
Metformin
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Immunosuppressive Agents

Insulin
Pharmacologic Actions
Glimepiride
Hypoglycemic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Anti-Arrhythmia Agents
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 06, 2009