Diabetes Mellitus Type 2Phase 3NCT00282971

A Clinical Trial Assessing The Impact Of Inhaled Insulin On Glucose Control In Patients With Type 2 Diabetes Mellitus

A Phase 3 study testing Inhaled Insulin (Exubera) in people with Diabetes Mellitus Type 2, run by Pfizer at 64 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents Read more about this study

Who is it for?: Ages 35 to 80 years
Conditions the study is for: Diabetes Mellitus Type 2
What is being tested?: Inhaled Insulin (Exubera)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 354 participants
Where: 64 sitesin 7 countries
Study dates: 6 Mar 2006to 19 Feb 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diabetes mellitus type 2
Failing two or more oral anti-diabetic agents

Who cannot join

Asthma, COPD
Smoking

Trial locations and contacts

64 sites in 7 countries.

Country

City, postcode or hospital

64 sites in 7 countries

Spain17 sites

Hospital General Universitario de Alicante
Alicante, 03010
Hospital de La Santa Creu I Sant Pau
Barcelona, 08025
Hospital General Universitario Valle de Hebron
Barcelona, 08035
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Universitario Puerta de Hierro
Madrid, 28035
Hospital 12 de Octubre
Madrid, 28041
Hospital de Mostoles
Madrid, 28935
Complejo Hospitalario Carlos Haya Hospital Civil - Pabellon C
Málaga, 29009
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33006
Clinica Universitaria de Navarra
Pamplona, Navarre, 31008
Hospital Montecelo
Pontevedra, 36071
Hospital Clinico Universitario de Santiago
Santiago de Compostela, A Coruña, 15706
Hospital de Conxo
Santiago de Compostela, A Coruña, 15706
Hospital Mutua de Terrassa
Terrassa, Barcelona, 08221
Hospital Universitario La Fe
Valencia, 46009
Hospital Clinico Universitario de Valencia
Valencia, 46010
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009

Other trials in Spain

France16 sites

Groupe Hospitalier Sud/Service d'Endocrinologie
Amiens, 80094
Private Practise
Armentières, 59427
Service d'Endocrinologie-
Bondy, 93143
Hopital LA Cavale Blanche, Service de Diabetologie
Brest, 29609
CHU Cote de Nacre, Service d'Endocrinologie
Cean Cedex, 14033
Private Practise
Chartres, 28000
Office of Antoine Lemaire, MD
Lille, 59000
Centre Hospitalier Bretagne Sud
Lorient, 56322
Hopital Lapeyronnie Sce des Maladies
Montpellier, 34295
Hotel Dieu CHU, Clinique d´Endocrinologie, Maladie Metaboliques, Nutrition
Nantes, Cedex 01, F-44035
Hopital Saint Michel
Paris, 75015
Hopital Bichat, Service d'Endocrinology
Paris, 75877
Hopital Robert Debre
Reims, 51100
C.H. Sud, Diabetologie
Rennes, 35056
Centre Hospitalier Victor Provo
Roubaix, 59100
Hôpital Jeanne d'Arc - Dommartin les Toul
Toul, 54201

Other trials in France

Canada14 sites

Maritime Research Center
Bathurst, New Brunswick, E2A 4X7
Laboratoire Sante Le Gaspesien Inc.
Bonaventure, Quebec, G0C 1E0
Douglas Tweel M.D. Professional Corporation
Charlottetown, Prince Edward Island, C1A 1L2
Centre de santé et de services sociaux de Chicoutimi, Centre de médecine genique communataire
Chicoutimi, Quebec, G7H 5H6
Gain Medical Center
Coquitlam, British Columbia, V3K 3P4
Rhodin Recherche Clinique
Drummondville, Quebec, J2B 1H8
Q & T Research Outaouais Inc.
Gatineau, Quebec, J8Y 6S9
Hopital Charles LeMoyne
Greenfield Park, Quebec, J4V2H1
Office of Dr. Salim Sunderji
London, Ontario, N6P 1A9
Orillia Soldier's Memorial Hospital
Orillia, Ontario, L3V 2Z6
Hopital Laval
Saint-Foy, Quebec, G1V 4G5
Centre Medical des Carrieres
Saint-Marc-des-Carrieres, Quebec, G0A 4B0
CIC Mauricie Inc.
Trois-Rivières, Quebec, G8T 7A1
Misericordia Health Centre
Winnipeg, Manitoba, R3C 1A2

Other trials in Canada

Portugal6 sites

Hospital Infante D. Pedro
Aveiro, 3814-096
Hospitais da Universidade de Coimbra
Coimbra, 3000-075
Associação Protectora dos Diabéticos de Portugal
Lisbon, 1250-203
Serviço de Endocrinologia - Hospital de Egas Moniz
Lisbon, 1300
Hospital Geral de Santo António
Porto, 4099-001
Centro Hospitalar de Torres Vedras
Torres Vedras, 2560-324

Other trials in Portugal

Greece5 sites

General Hospital of Athens "Laikon", 1st Propedeutic University Internal Medicine Clinic
Athens, 11527
"Hygeia" Diagnostic and Therapeutic Center of Athens, Diabetes Clinic
Athens, 151 23
"ATTIKON" University General Hospital, 2nd Propedeutic University Internal Medicine Clinic
Haidari, 124 62
Peripheral General Hospital of Nikaia "Ag. Panteleimon", Internal Medicine Department
Pireaus, 18454
University General Hospital of Thessaloniki "A.H.E.P.A." 1st Propedeutic University Internal Medicin
Thessaloniki, 546 36

Other trials in Greece

Sweden3 sites

Ängelholms sjukhus
Ängelholm, 262 81
Sodersjukhuset
Stockholm, 118 83
Karolinska US Huddinge
Stockholm, 141 86

Other trials in Sweden

Turkey (Türkiye)3 sites

Hacettepe University Medical School Department of Endocrinology
Ankara
Istanbul University Istanbul Medical School, Department of Endocrinology
Istanbul, 34390
Dokuz Eylul University Medical School, Department of Endocrinology
Izmir, 35340

Other trials in Turkey (Türkiye)

About this study

Official title: A Six Month, Open-label Outpatient, Parallel Group Trial Assessing The Impact Of Inhaled Insulin (Exubera(Registered)) On Glycemic Control In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On Two Oral Anti-diabetic Agents

To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents

Conditions: Diabetes Mellitus Type 2
Being tested: Inhaled Insulin (Exubera), Standard of Care
Keywords: Type 2 diabetes melllitus
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Inhaled Insulin (Exubera)Drug
Addition of inhaled insulin to pre-existing oral diabetes therapy.
Standard of CareOther
Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators

Study groups in NCT00282971
Study group	Role	What they receive
Inhaled Insulin	Experimental	Inhaled insulin plus oral therapy Receives: Drug: Inhaled Insulin (Exubera)
Standard of Care	Other	Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators Receives: Other: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
[(week 24 value - baseline value)/baseline value]*100%
Measured: 4, 12 and 24 weeks

Secondary outcomes (2)

Percentage of Participants Achieving Glycemic Control by Visit
2 definitions of good glycemic control were used: an HbA1c result of ≤6.5% or ≤7.0%
Measured: 4, 12 and 24 weeks
Change From Baseline in FEV1 at Week 24 LOCF
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Mar 200619 Feb 2008

First posted27 Jan 2006 (estimated)
Study start6 Mar 2006
Primary completion19 Feb 2008
Study completion19 Feb 2008

Why it stopped: Terminated as marketing of this product will be discontinued

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 354 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00282971
Sponsor's protocol ID: A2171063
Other IDs: EXACTA, 2005-003504-11, 2005
Status last verified: Apr 2019
First submitted: 26 Jan 2006
Last updated: 2 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Six Month, Open-label Outpatient, Parallel Group Trial Assessing The Impact Of Inhaled Insulin (Exubera(Registered)) On Glycemic Control In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On Two Oral Anti-diabetic Agents
ClinicalTrials.gov ID: NCT00282971
Acronym / sponsor ID: A2171063
Conditions: Diabetes Mellitus Type 2
Keywords: Type 2 diabetes melllitus
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated as marketing of this product will be discontinued
Enrolment: 354 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 6 Mar 2006 (actual)
Primary completion: 19 Feb 2008 (actual)
Study completion: 19 Feb 2008 (actual)
First posted: 27 Jan 2006 (estimated)
Results: Posted 26 Aug 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Inhaled Insulin	Experimental	Drug: Inhaled Insulin (Exubera)Inhaled insulin plus oral therapy
Standard of Care	Other	Other: Standard of CareStandard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators

Who may qualify

Ages: 35 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Diabetes mellitus type 2
Failing two or more oral anti-diabetic agents

Key exclusion criteria (2 listed)

Asthma, COPD
Smoking

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Inhaled Insulin (Exubera)Addition of inhaled insulin to pre-existing oral diabetes therapy.	Drug	Inhaled Insulin
Standard of CareStandard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators	Other	Standard of Care

Primary outcome

Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
Time frame: 4, 12 and 24 weeks
[(week 24 value - baseline value)/baseline value]*100%

2 secondary outcomes

Percentage of Participants Achieving Glycemic Control by Visit
Time frame: 4, 12 and 24 weeks
Change From Baseline in FEV1 at Week 24 LOCF
Time frame: 24 weeks

Results and safety

Results posted to the registry on 26 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Inhaled Insulin	180	146
Standard of Care	171	149

Primary outcome: Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24

Time frame: 4, 12 and 24 weeks. Mean (Standard Deviation). Unit: percentage change

Measure	Inhaled Insulin n = 179	Standard of Care n = 170
week 4 (n=164 and 158, respectively)	-1.08 (0.61)	-0.62 (0.55)
week 12 (n=159 and 150, respectively)	-2.03 (0.97)	-1.37 (0.92)
week 24 (n=142 and 150, respectively)	-2.02 (1.10)	-1.44 (1.10)
week 24 (LOCF, n=175 and 170, respectively)	-1.94 (1.09)	-1.42 (1.09)

Population analysed: Out of 180 and 171 subjects that were treated with study drug and usual care, respectively, the Full Analysis Set (FAS)for each group which was analyzed for efficacy, was 179 and 170 subjects, respectively.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Inhaled Insulin	8 of 180 (4.4%)	123 of 180 (68.3%)	Not reported
Standard of Care	6 of 171 (3.5%)	98 of 171 (57.3%)	Not reported

Limitations and caveats (from the sponsor): Study terminated prematurely since the sponsor stopped marketing and manufacturing of EXUBERA and withdrew Market Authorization in Europe in September 2008. No efficacy, safety, or quality reason was associated with the premature halt of this study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Diabetes Mellitus Type 2

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Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

64 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Inhaled Insulin (Exubera) in people with Diabetes Mellitus Type 2, run by Pfizer at 64 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in Spain, France, Canada, Portugal, Greece and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 (time frame: 4, 12 and 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00282971.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.