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Efficacy and Safety of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes

NCT ID: NCT00348712

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

301 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-30

Study Completion Date

2008-03-05

Brief Summary

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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).

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An Investigational Drug Study in Adults With Type 2 Diabetes on Basal Insulin (MK-0941-006)

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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 ACTIVE_COMPARATOR

inhaled human insulin

Intervention Type DRUG

Treat-to-target dose titration scheme, inhalation.

metformin

Intervention Type DRUG

Tablets, 2000 mg/day.

B

Group Type ACTIVE_COMPARATOR

rosiglitazone

Intervention Type DRUG

Tablets, 4 mg once or twice daily.

metformin

Intervention Type DRUG

Tablets, 2000 mg/day.

Interventions

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rosiglitazone

Tablets, 4 mg once or twice daily.

Intervention Type DRUG

inhaled human insulin

Treat-to-target dose titration scheme, inhalation.

Intervention Type DRUG

metformin

Tablets, 2000 mg/day.

Intervention Type DRUG

Other Intervention Names

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NN1998

Eligibility Criteria

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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
Minimum Eligible Age

18 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

Ebreichsdorf, , Austria

Site Status

Novo Nordisk Investigational Site

Vienna, , Austria

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Novo Nordisk Investigational Site

Vienna, , Austria

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Novo Nordisk Investigational Site

Joensuu, , Finland

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Novo Nordisk Investigational Site

Kirkkonummi, , Finland

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Novo Nordisk Investigational Site

Turku, , Finland

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Novo Nordisk Investigational Site

Corbeil-Essonnes, , France

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Novo Nordisk Investigational Site

La Rochelle, , France

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Novo Nordisk Investigational Site

Mougins, , 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

Pessac, , France

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Novo Nordisk Investigational Site

Pointe à Pitre, , France

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Novo Nordisk Investigational Site

Roubaix, , France

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Novo Nordisk Investigational Site

Tours, , France

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Novo Nordisk Investigational Site

Vénissieux, , France

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Novo Nordisk Investigational Site

Aschaffenburg, , Germany

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Novo Nordisk Investigational Site

Augsburg, , Germany

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Novo Nordisk Investigational Site

Bad Mergentheim, , Germany

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Novo Nordisk Investigational Site

Berlin, , Germany

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Novo Nordisk Investigational Site

Darmstadt, , Germany

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Novo Nordisk Investigational Site

Dormagen, , Germany

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Novo Nordisk Investigational Site

Dresden, , Germany

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Novo Nordisk Investigational Site

Duisburg, , Germany

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Novo Nordisk Investigational Site

Flörsheim, , Germany

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Novo Nordisk Investigational Site

Frankfurt, , Germany

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Novo Nordisk Investigational Site

Fulda, , Germany

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Novo Nordisk Investigational Site

Genthin, , Germany

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Novo Nordisk Investigational Site

Hermaringen, , Germany

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Novo Nordisk Investigational Site

Kutenholz-Mulsum, , Germany

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Novo Nordisk Investigational Site

Münster, , Germany

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Novo Nordisk Investigational Site

Pirna, , Germany

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Novo Nordisk Investigational Site

Schkeuditz, , Germany

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Novo Nordisk Investigational Site

Wangen, , Germany

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Novo Nordisk Investigational Site

Wiesbaden, , Germany

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Novo Nordisk Investigational Site

Dublin, , Ireland

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Novo Nordisk Investigational Site

Dublin, , Ireland

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Novo Nordisk Investigational Site

Waterford, , Ireland

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Novo Nordisk Investigational Site

Delft, , Netherlands

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Novo Nordisk Investigational Site

Drachten, , Netherlands

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Novo Nordisk Investigational Site

Rijswijk, , Netherlands

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Novo Nordisk Investigational Site

Roelofarendsveen, , Netherlands

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Novo Nordisk Investigational Site

The Hague, , Netherlands

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Novo Nordisk Investigational Site

The Hague, , Netherlands

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Novo Nordisk Investigational Site

Vlodrop, , Netherlands

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Novo Nordisk Investigational Site

Zwijndrecht, , Netherlands

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Novo Nordisk Investigational Site

Alzira, , Spain

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Novo Nordisk Investigational Site

Barcelona, , Spain

Site Status

Novo Nordisk Investigational Site

Gijón, , Spain

Site Status

Novo Nordisk Investigational Site

Majadahonda, , Spain

Site Status

Novo Nordisk Investigational Site

Palma de Mallorca, , Spain

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Novo Nordisk Investigational Site

Partida de Bacarot, , Spain

Site Status

Novo Nordisk Investigational Site

Pontevedra, , Spain

Site Status

Novo Nordisk Investigational Site

Reus, , Spain

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Novo Nordisk Investigational Site

San Juan, , Spain

Site Status

Novo Nordisk Investigational Site

Seville, , Spain

Site Status

Novo Nordisk Investigational Site

Interlaken-Unterseen, , Switzerland

Site Status

Novo Nordisk Investigational Site

Olten, , Switzerland

Site Status

Novo Nordisk Investigational Site

Zurich, , Switzerland

Site Status

Novo Nordisk Investigational Site

Aberdeen, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Bath, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Belfast, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Birmingham, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Bradford-on-Avon, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Guildford, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Hull, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Northampton, , United Kingdom

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Novo Nordisk Investigational Site

Salford, , United Kingdom

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Novo Nordisk Investigational Site

Swansea, , United Kingdom

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Novo Nordisk Investigational Site

Trowbridge, , United Kingdom

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Novo Nordisk Investigational Site

Trowbridge, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Wirral, Merseyside, , United Kingdom

Site Status

Novo Nordisk Investigational Site

York, , United Kingdom

Site Status

Countries

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Austria Finland France Germany Ireland Netherlands Spain Switzerland United Kingdom

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2006-000796-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN1998-1390

Identifier Type: -

Identifier Source: org_study_id

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