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

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00348712

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).

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: rosiglitazone Drug: inhaled human insulin Drug: metformin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Inhaled Pre-Prandial Human Insulin Plus Metformin Versus Rosiglitazone Plus Metformin in Type 2 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Hypoglycemia

Drug Information available for: Insulin Rosiglitazone Rosiglitazone Maleate Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Treatment difference in HbA1c [ Time Frame: After 26 weeks ] [ 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: For the duration of the trial ] [ Designated as safety issue: No ]
Lung function [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
Blood glucose [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
Hypoglycaemia [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]

Enrollment:	298
Study Start Date:	November 2006
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: inhaled human insulin Treat-to-target dose titration scheme, inhalation. Drug: metformin Tablets, 2000 mg/day.
B: Active Comparator	Drug: rosiglitazone Tablets, 4 mg once or twice daily. Drug: metformin Tablets, 2000 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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348712

Locations

Austria

Vienna, Austria
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

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Gitte S. Fuchs, BSc

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:	NN1998-1390, EudraCT No: 2006-000796-15
Study First Received:	July 5, 2006
Last Updated:	June 24, 2008
ClinicalTrials.gov Identifier:	NCT00348712 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; Spain: Spanish Agency of Medicines; Finland: National Agency for Medicines; Austria: Federal Ministry for Health and Women; Switzerland: Swissmedic; Ireland: Irish Medicines Board; Netherlands: The Central Committee on Research Involving Human Subjects (CCM; Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Rosiglitazone
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Glucose Metabolism Disorders
Rosiglitazone
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on September 11, 2009