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

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

MedlinePlus related topics:

Diabetes Hypoglycemia

ChemIDplus related topics:

Insulin Metformin Metformin hydrochloride Rosiglitazone Rosiglitazone Maleate

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 Pre-Prandial Human Insulin Plus Metformin Versus Rosiglitazone Plus Metformin in Type 2 Diabetes

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 A/S

More Information

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

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN1998-1390, EudraCT No: 2006-000796-15
First Received:	July 5, 2006
Last Updated:	June 24, 2008
ClinicalTrials.gov Identifier:	NCT00348712
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