Diabetes MellitusPhase 3NCT00134147
A Clinical Trial Assessing the Impact of the Availability of Inhaled Insulin on Glucose Control
A Phase 3 study testing Inhaled Insulin in people with Diabetes Mellitus, run by Pfizer at 121 sites in 7 countries.
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
- What is being tested?
- Inhaled Insulin
- How many people
- 1,100 participants
- Where
- 121 sitesin 7 countries
- Study dates
- Apr 2005to May 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
121 sites in 7 countries.
121 sites in 7 countries
Germany35 sites
Pfizer Investigational Site
Altenburg, 04600
Pfizer Investigational Site
Aschaffenburg, 63739
Pfizer Investigational Site
Bad Mergentheim, 97980
Pfizer Investigational Site
Bad Oeynhausen/ Volmerdingen, 32549
Pfizer Investigational Site
Berlin, 10115
Pfizer Investigational Site
Berlin, 12687
Pfizer Investigational Site
Berlin, 14057
Pfizer Investigational Site
Delmenhorst, 27753
Pfizer Investigational Site
Dresden, 01219
Pfizer Investigational Site
Ebersdorf, 96237
Pfizer Investigational Site
Eisenach, 99817
Pfizer Investigational Site
Falkensee, 14612
Pfizer Investigational Site
Furth im Wald, 93437
Pfizer Investigational Site
Hamburg, 21073
Pfizer Investigational Site
Hamburg, 22391
Pfizer Investigational Site
Haßloch, 67454
Pfizer Investigational Site
Künzing, 94550
Pfizer Investigational Site
Leipzig, 04103
Pfizer Investigational Site
Meissen, 01662
Pfizer Investigational Site
Mittweida, 09648
Pfizer Investigational Site
Münster, 48145
Pfizer Investigational Site
Münster, 48153
Pfizer Investigational Site
Offenbach, 63065
Pfizer Investigational Site
Offenburg, 77654
Pfizer Investigational Site
Oschatz, 04758
Pfizer Investigational Site
Pirna, 01796
Pfizer Investigational Site
Riedlhuette, 94566
Pfizer Investigational Site
Riesa, 01587
Pfizer Investigational Site
Rossach, 96269
Pfizer Investigational Site
Schwabenheim, 55270
Pfizer Investigational Site
St.Ingbert, 66386
Pfizer Investigational Site
Surwold, 26903
Pfizer Investigational Site
Wangen, 88239
Pfizer Investigational Site
Wangen / Allgaeu, 88239
Pfizer Investigational Site
Witten, 58455
United Kingdom21 sites
Pfizer Investigational Site
Ayr, Ayrshire, KA7 1BJ
Pfizer Investigational Site
Birmingham, B9 5SS
Pfizer Investigational Site
Blackpool, Lancashire, FY3 7EN
Pfizer Investigational Site
Bolton, BL3 6TL
Pfizer Investigational Site
Canterbury, CT1 3HX
Pfizer Investigational Site
Colney, Norwich, NR4 7UY
Pfizer Investigational Site
Dundee, Tayside, DD1 9SY
Pfizer Investigational Site
Haywards Heath, West Sussex, RH16 4EX
Pfizer Investigational Site
Headington, Oxford, OX3 7LJ
Pfizer Investigational Site
Letchworth Garden City, Hertfordshire, SG6 4UB
Pfizer Investigational Site
Liverpool, L7 8XP
Pfizer Investigational Site
Penarth, South Glamorgan, CF64 2XX
Pfizer Investigational Site
Penzance, CORNWALL, TR18 4JH
Pfizer Investigational Site
Plymouth, DEVON, PL6 8BX
Pfizer Investigational Site
Salford, M6 8HD
Pfizer Investigational Site
Sidcup, Kent, DA14 6LT
Pfizer Investigational Site
St Austell, Cornwall, PL26 7RL
Pfizer Investigational Site
Thornhill, Cardiff, CF14 9BB
Pfizer Investigational Site
Truro, Cornwall, TR1 3LJ
Pfizer Investigational Site
Whitstable, Kent, CT5 3QU
Pfizer Investigational Site
York, YO31 8HE
United States18 sites
Pfizer Investigational Site
Baltimore, Maryland, 21230
Pfizer Investigational Site
Charlotte, North Carolina, 28207
Pfizer Investigational Site
Charlotte, North Carolina, 28212
Pfizer Investigational Site
Columbus, Georgia, 31904
Pfizer Investigational Site
Hershey, Pennsylvania, 17033-0850
Pfizer Investigational Site
Jacksonville, Florida, 32208
Pfizer Investigational Site
Jacksonville, Florida, 32209
Pfizer Investigational Site
La Jolla, California, 92037
Pfizer Investigational Site
Medford, Oregon, 97504-8491
Pfizer Investigational Site
Miami, Florida, 33136
Pfizer Investigational Site
New Orleans, Louisiana, 70121
Pfizer Investigational Site
Overland Park, Kansas, 66211
Pfizer Investigational Site
Raleigh, North Carolina, 27609
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Antonio, Texas, 78237
Pfizer Investigational Site
San Diego, California, 92128
Pfizer Investigational Site
Spartanburg, South Carolina, 29303
Pfizer Investigational Site
Washington D.C., District of Columbia, 20010
Italy14 sites
Pfizer Investigational Site
Bari, 70124
Pfizer Investigational Site
Catania, 95122
Pfizer Investigational Site
Florence, 50134
Pfizer Investigational Site
Genova, 16132
Pfizer Investigational Site
Milan, 20132
Pfizer Investigational Site
Naples, 80131
Pfizer Investigational Site
Padova, 35128
Pfizer Investigational Site
Palermo, 90127
Pfizer Investigational Site
Pescara, 65100
Pfizer Investigational Site
Pisa, 56124
Pfizer Investigational Site
Roma, 00133
Pfizer Investigational Site
Torino, 10126
Pfizer Investigational Site
Udine, 33100
Pfizer Investigational Site
Verona, 37126
Spain14 sites
Pfizer Investigational Site
Badalona, Barcelona, 08916
Pfizer Investigational Site
Barakaldo, VIZCAYA, 48903
Pfizer Investigational Site
Barcelona, BARCELONA, 08003
Pfizer Investigational Site
Barcelona, BARCELONA, 08017
Pfizer Investigational Site
Barcelona, BARCELONA, 08036
Pfizer Investigational Site
Bilbao, VIZCAYA, 48013
Pfizer Investigational Site
Cadiz, CADIZ, 11009
Pfizer Investigational Site
Girona, GERONA, 17007
Pfizer Investigational Site
Granada, GRANADA, 18012
Pfizer Investigational Site
Las Palmas, LAS Palmas de GRAN Canaria, 35010
Pfizer Investigational Site
Madrid, Madrid, 28034
Pfizer Investigational Site
Madrid, Madrid, 28040
Pfizer Investigational Site
Seville, SEVILLA, 41014
Pfizer Investigational Site
Valencia, Valencia, 46017
Canada10 sites
Pfizer Investigational Site
Calgary, Alberta, T2L 1K8
Pfizer Investigational Site
Charlottetown, Prince Edward Island, C1A 5Y9
Pfizer Investigational Site
Corunna, Ontario, N0N 1G0
Pfizer Investigational Site
Edmonton, Alberta, T5J 3N4
Pfizer Investigational Site
Laval, Quebec, H7T 2P5
Pfizer Investigational Site
Montreal, Quebec, H3A 1A1
Pfizer Investigational Site
Oakville, Ontario, L6H 3P1
Pfizer Investigational Site
Red Deer, Alberta, T4N 6V7
Pfizer Investigational Site
Smith Falls, Ontario, K7A 4W8
Pfizer Investigational Site
Winnipeg, Manitoba, R3E 3P4
France9 sites
Pfizer Investigational Site
Béthune, 62408
Pfizer Investigational Site
Bourg-en-Bresse, 01012
Pfizer Investigational Site
Bron, 69500
Pfizer Investigational Site
Corbeil-Essonnes, 91106
Pfizer Investigational Site
La Rochelle, 17019
Pfizer Investigational Site
Montpellier, F-34295
Pfizer Investigational Site
Nantes, 44000
Pfizer Investigational Site
Roubaix, 59100
Pfizer Investigational Site
Tours, 37044
About this study
Official title: A One Year, Open-Label Outpatient, Parallel Group Trial Assessing the Impact of the Availability of Inhaled Insulin (Exubera) on Glycemic Control in Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled on a Minimum of 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
- Being tested
- Inhaled Insulin
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled InsulinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated hemoglobin
Secondary outcomes (5)
Percent of patients achieving good control of fasting glucose and lipids
Rate of hypoglycemia
Changes in body weight
Patient satisfaction
Safety based on adverse events reported and laboratory tests
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2005 (estimated)
- Study startApr 2005
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- 1,100 participants
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00134147
- Sponsor's protocol ID
- A2171018
- Status last verified
- Apr 2008
- First submitted
- 22 Aug 2005
- Last updated
- 17 Apr 2008
- Results posted
- No
Publications
Freemantle N, Strack TR; Real World Trialists. Will availability of inhaled human insulin (Exubera) improve management of type 2 diabetes? The design of the Real World trial. Trials. 2006 Aug 10;7:25. doi: 10.1186/1745-6215-7-25.
PubMed 16901335
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A One Year, Open-Label Outpatient, Parallel Group Trial Assessing the Impact of the Availability of Inhaled Insulin (Exubera) on Glycemic Control in Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled on a Minimum of Two Oral Anti Diabetic Agents
- ClinicalTrials.gov ID
- NCT00134147
- Acronym / sponsor ID
- A2171018
- Conditions
- Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,100 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- Apr 2005
- Study completion
- May 2007 (actual)
- First posted
- 24 Aug 2005 (estimated)
- Results
- Not posted in the source record
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)
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 | Drug | – |
Primary outcome
Glycosylated hemoglobin
5 secondary outcomes
Percent of patients achieving good control of fasting glucose and lipids
Rate of hypoglycemia
Changes in body weight
Patient satisfaction
Safety based on adverse events reported and laboratory tests
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2008.
- Derived from this study: PubMed 16901335Freemantle N, Strack TR; Real World Trialists. Will availability of inhaled human insulin (Exubera) improve management of type 2 diabetes? The design of the Real World trial. Trials. 2006 Aug 10;7:25. doi: 10.1186/1745-6215-7-25.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
121 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 in people with Diabetes Mellitus, run by Pfizer at 121 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: finished, as of the sponsor's last update on 17 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 121 sites in Germany, United Kingdom, United States, Italy, Spain 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Glycosylated hemoglobin. 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 NCT00134147, which also lists 1 linked publication.
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 17 Apr 2008.