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

Sponsor:	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

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 Hypoglycemia

Drug Information available for: Insulin Insulin beef Glimepiride Metformin Metformin hydrochloride

U.S. FDA Resources

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:

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

No publications provided

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00469586 History of Changes
Other Study ID Numbers:	NN1998-1787, 2006-004623-12
Study First Received:	May 3, 2007
Last Updated:	February 22, 2011
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 February 09, 2012