Safety and Efficacy of Inhaled Insulin in Type 2 Diabetes - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00331604

Purpose

This trial is conducted in Asia, Europe and South America.

The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function tests, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin detemir in Type 2 Diabetes.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: inhaled human insulin Drug: insulin detemir Drug: insulin aspart	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Inhaled Pre-Prandial Human Insulin With the AERx® iDMS Versus s.c. Insulin Aspart in Type 2 Diabetes: A 104 Week, Open-Label, Multicenter, Randomised, Trial Followed by a 12 Week re-Randomised Extension to Investigate Safety and Efficacy

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin aspart Insulin Detemir

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Treatment difference in HbA1c [ Time Frame: after 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
Blood glucose [ Time Frame: after 52, 104 and 116 weeks of treatment ] [ Designated as safety issue: No ]
Body weight [ Time Frame: during treatment ] [ Designated as safety issue: No ]
Lung function [ Time Frame: after 52, 104 and 116 weeks of treatment ] [ Designated as safety issue: No ]
Hypoglycaemia [ Time Frame: from 12 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment:	618
Study Start Date:	September 2006
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: inhaled human insulin Treat-to-target dose titration scheme, inhalation. Drug: insulin detemir Injection s.c., 50% of daily dose.
B: Active Comparator	Drug: insulin detemir Injection s.c., 50% of daily dose. Drug: insulin aspart Treat-to-target dose titration scheme, injection s.c.
C: Active Comparator	Drug: insulin detemir Injection s.c., 50% of daily dose. Drug: insulin aspart Treat-to-target dose titration scheme, injection s.c. Drug: insulin aspart Treat-to-target dose titration scheme, injection s.c. After 2 years.

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
Currently treated with insulin
Body mass index of (BMI) less than or equal to 40.0 kg/m2
HbA1c less than or equal to 11.0%

Exclusion Criteria:

Total daily insulin dosage less than or equal to 100 IU or U/day
Current smoking or smoking within the last 6 months
Cardiac problems
Uncontrolled hypertension
Current proliferative retinopathy or maculopathy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331604

Locations

Brazil

São Paulo - SP - Brazil, Brazil
Denmark

AArhus, Denmark
France

Narbonne, France
Germany

Völklingen, Germany
Hong Kong

Shatin, New Territories, Hong Kong, Hong Kong
Israel

Jerusalem, Israel
Italy

Pisa, Italy
Singapore

Singapore, Singapore
Spain

Almeria, Spain
Taiwan

Taipei, Taiwan
United Kingdom

Salford, United Kingdom

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:	Trine Dano Klingberg	Novo Nordisk
Study Director:	Lisbeth Bonefeld	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:	NN1998-2161, EudraCT No: 2005-005378-58
Study First Received:	May 24, 2006
Last Updated:	June 24, 2008
ClinicalTrials.gov Identifier:	NCT00331604 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; Taiwan: Department of Health; Spain: Spanish Agency of Medicines; Singapore: Health Sciences Authority; United Kingdom: Medicines and Healthcare Products Regulatory; Denmark: Danish Medicines Agency; Israel: Israeli Health Ministry Pharmaceutical Administration; Brazil: National Health Surveillance Agency; Italy: National Monitoring Centre for Clinical Trials - Ministry of He; Germany: Federal Institute for Drugs and Medical Devices; Hong Kong: Department of Health

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on September 01, 2009