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Safety and Efficacy of Inhaled Insulin in Type 2 Diabetes

NCT ID: NCT00331604

Last Updated: 2017-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

618 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-05-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

inhaled human insulin

Intervention Type DRUG

Treat-to-target dose titration scheme, inhalation.

insulin detemir

Intervention Type DRUG

Injection s.c., 50% of daily dose.

B

Group Type ACTIVE_COMPARATOR

insulin detemir

Intervention Type DRUG

Injection s.c., 50% of daily dose.

insulin aspart

Intervention Type DRUG

Treat-to-target dose titration scheme, injection s.c.

C

Group Type ACTIVE_COMPARATOR

insulin detemir

Intervention Type DRUG

Injection s.c., 50% of daily dose.

insulin aspart

Intervention Type DRUG

Treat-to-target dose titration scheme, injection s.c.

insulin aspart

Intervention Type DRUG

Treat-to-target dose titration scheme, injection s.c. After 2 years.

Interventions

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inhaled human insulin

Treat-to-target dose titration scheme, inhalation.

Intervention Type DRUG

insulin detemir

Injection s.c., 50% of daily dose.

Intervention Type DRUG

insulin aspart

Treat-to-target dose titration scheme, injection s.c.

Intervention Type DRUG

insulin aspart

Treat-to-target dose titration scheme, injection s.c. After 2 years.

Intervention Type DRUG

Other Intervention Names

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NN304 Levemir

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Campinas, , Brazil

Site Status

Novo Nordisk Investigational Site

Higienópolis, , Brazil

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Novo Nordisk Investigational Site

Porto Alegre, , Brazil

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Novo Nordisk Investigational Site

São Paulo, , Brazil

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Novo Nordisk Investigational Site

Århus C, , Denmark

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Novo Nordisk Investigational Site

Hillerød, , Denmark

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Novo Nordisk Investigational Site

Hvidovre, , Denmark

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Novo Nordisk Investigational Site

Brest, , France

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Novo Nordisk Investigational Site

Grenoble, , France

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Novo Nordisk Investigational Site

La Rochelle, , France

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Novo Nordisk Investigational Site

Nanterre, , France

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Novo Nordisk Investigational Site

Narbonne, , France

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Novo Nordisk Investigational Site

Nevers, , France

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Novo Nordisk Investigational Site

Strasbourg, , France

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Novo Nordisk Investigational Site

Toulouse, , France

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Novo Nordisk Investigational Site

Bad Harzburg, , Germany

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Novo Nordisk Investigational Site

Bad Kreuznach, , Germany

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Novo Nordisk Investigational Site

Bad Lauterberg im Harz, , Germany

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Novo Nordisk Investigational Site

Dresden, , Germany

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Novo Nordisk Investigational Site

Dresden, , Germany

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Novo Nordisk Investigational Site

Friedrichsthal, , Germany

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Novo Nordisk Investigational Site

Hamburg, , Germany

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Novo Nordisk Investigational Site

Hamburg, , Germany

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Novo Nordisk Investigational Site

Herrenberg, , Germany

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Novo Nordisk Investigational Site

Hohenmölsen, , Germany

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Novo Nordisk Investigational Site

Neumünster, , Germany

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Novo Nordisk Investigational Site

Neuwied, , Germany

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Novo Nordisk Investigational Site

Saint Ingbert, , Germany

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Novo Nordisk Investigational Site

Schkeuditz, , Germany

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Novo Nordisk Investigational Site

Speyer, , Germany

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Novo Nordisk Investigational Site

Völklingen, , Germany

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Novo Nordisk Investigational Site

Warburg, , Germany

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Novo Nordisk Investigational Site

Shatin, New Territories, , Hong Kong

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Novo Nordisk Investigational Site

Beersheba, , Israel

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Novo Nordisk Investigational Site

Holon, , Israel

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Novo Nordisk Investigational Site

Jerusalem, , Israel

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Novo Nordisk Investigational Site

Bari, , Italy

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Novo Nordisk Investigational Site

Catania, , Italy

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Novo Nordisk Investigational Site

Catanzaro, , Italy

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Novo Nordisk Investigational Site

Milan, , Italy

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Novo Nordisk Investigational Site

Perugia, , Italy

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Novo Nordisk Investigational Site

Pescara, , Italy

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Novo Nordisk Investigational Site

Pisa, , Italy

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Novo Nordisk Investigational Site

Roma, , Italy

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Novo Nordisk Investigational Site

Roma, , Italy

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Novo Nordisk Investigational Site

San Giovanni Rotondo, , Italy

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Novo Nordisk Investigational Site

Verona, , Italy

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Novo Nordisk Investigational Site

Singapore, , Singapore

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Novo Nordisk Investigational Site

Singapore, , Singapore

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Novo Nordisk Investigational Site

Almería, , Spain

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Novo Nordisk Investigational Site

Cáceres, , Spain

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Novo Nordisk Investigational Site

Elche, , Spain

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Novo Nordisk Investigational Site

Granada, , Spain

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Novo Nordisk Investigational Site

Lugo, , Spain

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Novo Nordisk Investigational Site

Mostoles - Madrid -, , Spain

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Novo Nordisk Investigational Site

Seville, , Spain

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Novo Nordisk Investigational Site

Valladolid, , Spain

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Novo Nordisk Investigational Site

Xátiva, , Spain

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Novo Nordisk Investigational Site

Taichung, , Taiwan

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Novo Nordisk Investigational Site

Taipei, , Taiwan

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Novo Nordisk Investigational Site

Taipei, , Taiwan

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Novo Nordisk Investigational Site

Aberdeen, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Ayr, , United Kingdom

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Novo Nordisk Investigational Site

Bristol, , United Kingdom

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Novo Nordisk Investigational Site

Cosham, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Edgbaston, Birmingham, , United Kingdom

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Novo Nordisk Investigational Site

Edinburgh, , United Kingdom

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Novo Nordisk Investigational Site

Livingstone, , United Kingdom

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Novo Nordisk Investigational Site

Nottingham, , United Kingdom

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Novo Nordisk Investigational Site

Plymouth, , United Kingdom

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Novo Nordisk Investigational Site

Salford, , United Kingdom

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Novo Nordisk Investigational Site

Sheffield, , United Kingdom

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Novo Nordisk Investigational Site

Wirral, Merseyside, , United Kingdom

Site Status

Countries

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Brazil Denmark France Germany Hong Kong Israel Italy Singapore Spain Taiwan United Kingdom

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2005-005378-58

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN1998-2161

Identifier Type: -

Identifier Source: org_study_id

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