A Clinical Trial Comparing the Efficacy and Safety of Exubera® and Lantus®

NCT ID: NCT00391027

Last Updated: 2015-07-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

261 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-08-31

Brief Summary

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To compare efficacy and safety of Exubera® vs Lantus® in patients with type 2 diabetes mellitus.

Detailed Description

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Conditions

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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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Insulin Glargine (Lantus®)

Group Type ACTIVE_COMPARATOR

Insulin Glargine (Lantus®)

Intervention Type DRUG

Patient will be randomized to Lantus® while remaining on pre-study oral hypoglycemic agents.

Inhaled Human Insulin (Exubera®)

Group Type ACTIVE_COMPARATOR

Inhaled Human Insulin (Exubera®)

Intervention Type DRUG

Patient will be randomized inhaled insulin while remaining on pre-study oral hypoglycemic agents.

Interventions

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Insulin Glargine (Lantus®)

Patient will be randomized to Lantus® while remaining on pre-study oral hypoglycemic agents.

Intervention Type DRUG

Inhaled Human Insulin (Exubera®)

Patient will be randomized inhaled insulin while remaining on pre-study oral hypoglycemic agents.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diabetes Mellitus, Type 2 on oral agents
* Age \> 30 years

Exclusion Criteria

* Severe Asthma, severe Chronic Obstructive Pulmonary Disease
* Smoking
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Bornem, , Belgium

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Brussels, , Belgium

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Genk, , Belgium

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Liège, , Belgium

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Kuopio, , Finland

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Lahti, , Finland

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Oulu, , Finland

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Besançon, , France

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Corbeil-Essonnes, , France

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La Rochelle, , France

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Marseille, , France

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Paris, , France

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Valenciennes, , France

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Altenburg, , Germany

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Eisenach, , Germany

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Hamburg, , Germany

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Hohenmölsen, , Germany

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Leipzig, , Germany

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Neuss, , Germany

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Riesa, , Germany

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Wangen / Allgaeu, , Germany

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's-Hertogenbosch, , Netherlands

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Eindhoven, , Netherlands

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Nijmegen, , Netherlands

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The Hague, , Netherlands

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Venlo, , Netherlands

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Hønefoss, Buskerud, Norway

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Bergen, , Norway

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Jessheim, , Norway

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Lysaker, , Norway

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Skedsmokorset, , Norway

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Lodz, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Warsaw, , Poland

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Łask, , Poland

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A Coruña, A Coruña, Spain

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Palma de Mallorca, Balearic Islands, Spain

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Huelva, Huelva, Spain

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Málaga, Malaga, Spain

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Inca, Mallorca, Spain

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San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain

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Alzira, Valencia, Spain

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Valencia, Valencia, Spain

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Borås, , Sweden

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Eksjö, , Sweden

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Gothenburg, , Sweden

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Gothenburg, , Sweden

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Härnösand, , Sweden

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Helsingborg, , Sweden

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Järfälla, , Sweden

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Kristianstad, , Sweden

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Linköping, , Sweden

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Luleå, , Sweden

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Malmo, , Sweden

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Motala, , Sweden

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Stockholm, , Sweden

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Uddevalla, , Sweden

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Umeå, , Sweden

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Vaxjo, , Sweden

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Bruderholz, , Switzerland

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Sankt Gallen, , Switzerland

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Countries

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Belgium Finland France Germany Netherlands Norway Poland Spain Sweden Switzerland

Related Links

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Other Identifiers

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A2171084

Identifier Type: -

Identifier Source: org_study_id

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