Diabetes Mellitus, Type 2Phase 4NCT00391027
A Clinical Trial Comparing the Efficacy and Safety of Exubera® and Lantus®
A Phase 4 study testing Insulin Glargine (Lantus®) and Inhaled Human Insulin (Exubera®) in people with Diabetes Mellitus, Type 2, run by Pfizer at 62 sites in 10 countries.
Trial summary
To compare efficacy and safety of Exubera® vs Lantus® in patients with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin Glargine (Lantus®) and Inhaled Human Insulin (Exubera®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 62 sitesin 10 countries
- Study dates
- Dec 2006to Aug 2008
- Phase
- Phase 4
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes Mellitus, Type 2 on oral agents
- Age > 30 years
Who cannot join
- Severe Asthma, severe Chronic Obstructive Pulmonary Disease
- Smoking
Trial locations and contacts
62 sites in 10 countries.
62 sites in 10 countries
Sweden16 sites
Pfizer Investigational Site
Borås, 501 82
Pfizer Investigational Site
Eksjö, 575 36
Pfizer Investigational Site
Gothenburg, 412 55
Pfizer Investigational Site
Gothenburg, 41665
Pfizer Investigational Site
Härnösand, 871 82
Pfizer Investigational Site
Helsingborg, 25220
Pfizer Investigational Site
Järfälla, 177 31
Pfizer Investigational Site
Kristianstad, 291 54
Pfizer Investigational Site
Linköping, 581 85
Pfizer Investigational Site
Luleå, 972 33
Pfizer Investigational Site
Malmö, 211 52
Pfizer Investigational Site
Motala, 591 85
Pfizer Investigational Site
Stockholm, 118 83
Pfizer Investigational Site
Uddevalla, 451 50
Pfizer Investigational Site
Umeå, 901 85
Pfizer Investigational Site
Vaxjo, 351 85
Germany8 sites
Pfizer Investigational Site
Altenburg, 04600
Pfizer Investigational Site
Eisenach, 99817
Pfizer Investigational Site
Hamburg, 20253
Pfizer Investigational Site
Hohenmölsen, 06679
Pfizer Investigational Site
Leipzig, 04103
Pfizer Investigational Site
Neuss, 41460
Pfizer Investigational Site
Riesa, 01587
Pfizer Investigational Site
Wangen / Allgaeu, 88239
Spain8 sites
Pfizer Investigational Site
A Coruña, 15006
Pfizer Investigational Site
Alzira, Valencia, 46600
Pfizer Investigational Site
Huelva, 21080
Pfizer Investigational Site
Inca, Mallorca, 07300
Pfizer Investigational Site
Málaga, 29006
Pfizer Investigational Site
Palma de Mallorca, Balearic Islands, 07014
Pfizer Investigational Site
San Cristóbal de La Laguna, Santa CRUZ DE Tenerife, 38320
Pfizer Investigational Site
Valencia, 46015
France6 sites
Pfizer Investigational Site
Besançon, 25030
Pfizer Investigational Site
Corbeil-Essonnes, 91106
Pfizer Investigational Site
La Rochelle, 17019
Pfizer Investigational Site
Marseille, 13385
Pfizer Investigational Site
Paris, 75475
Pfizer Investigational Site
Valenciennes, 59300
Netherlands5 sites
Pfizer Investigational Site
's-Hertogenbosch, 5233 VG
Pfizer Investigational Site
Eindhoven, 5631 BM
Pfizer Investigational Site
Nijmegen, 6525 EC
Pfizer Investigational Site
The Hague, 2512 VA
Pfizer Investigational Site
Venlo, 5912 BL
Norway5 sites
Pfizer Investigational Site
Bergen, 5012
Pfizer Investigational Site
Hønefoss, Buskerud, 3505
Pfizer Investigational Site
Jessheim, 2050
Pfizer Investigational Site
Lysaker
Pfizer Investigational Site
Skedsmokorset, N-2020
Poland5 sites
Pfizer Investigational Site
Łask, 98-100
Pfizer Investigational Site
Lodz, 90-030
Pfizer Investigational Site
Lodz, 93-338
Pfizer Investigational Site
Lublin, 20-536
Pfizer Investigational Site
Warsaw, 02-097
Belgium4 sites
Pfizer Investigational Site
Bornem, 2800
Pfizer Investigational Site
Brussels, 1070
Pfizer Investigational Site
Genk, 3600
Pfizer Investigational Site
Liège, 4000
Finland3 sites
Pfizer Investigational Site
Kuopio, 70210
Pfizer Investigational Site
Lahti, 15110
Pfizer Investigational Site
Oulu, 90100
Switzerland2 sites
Pfizer Investigational Site
Bruderholz, 4101
Pfizer Investigational Site
Sankt Gallen, CH-9007
About this study
Official title: A Six Month, Open-Label Outpatient, Randomized Parallel Group Trial Assessing The Impact Of Dry Powder Inhaled Insulin (Exubera®) On Glycemic Control Compared To Insulin Glargine (Lantus®) In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combination Of Two Or More Oral Agents
To compare efficacy and safety of Exubera® vs Lantus® in patients with type 2 diabetes mellitus.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin Glargine (Lantus®), Inhaled Human Insulin (Exubera®)
- Keywords
- type 2 diabetes, insulin, glycemic control
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin Glargine (Lantus®)Drug
Patient will be randomized to Lantus® while remaining on pre-study oral hypoglycemic agents.
Inhaled Human Insulin (Exubera®)Drug
Patient will be randomized inhaled insulin while remaining on pre-study oral hypoglycemic agents.
| Study group | Role | What they receive |
|---|---|---|
| Insulin Glargine (Lantus®) | Active comparator | Not described Receives: Drug: Insulin Glargine (Lantus®) |
| Inhaled Human Insulin (Exubera®) | Active comparator | Not described Receives: Drug: Inhaled Human Insulin (Exubera®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
Change (measured as percent): HbA1c at observation minus HbA1c at baseline. Primary objective to demonstrate non-inferiority of inhaled insulin compared to insulin glargine for glycemic control after 26 weeks of treatment not attainable due to early termination of study; analyses were descriptive and graphical.
Measured: Baseline, Week 26
Secondary outcomes (16)
Change From Baseline in HbA1c Prior to Week 26
Change (measured as percent) from baseline calculated as HbA1c at observation minus HbA1c at baseline.
Measured: Baseline, Week 2, Week 4, Week 8, Week 12, and Week 18
Number of Subjects With HbA1c < 6.5 %
Number of subjects with glycemic control HbA1c measurement of < 6.5 % at observation.
Measured: Week 26
Number of Subjects With HbA1c < 7.0 %
Number of subjects with glycemic control HbA1c measurement of < 7.0 % at observation.
Measured: Week 26
Number of Subjects With HbA1c < 8.0 %
Number of subjects with glycemic control HbA1c measurement of < 8.0 % at observation.
Measured: Week 26
Change From Baseline in Fasting Plasma Glucose (FPG) Level
FPG measured as milligrams/deciliter (mg/dl). Change from baseline calculated as FPG at observation minus FPG at baseline.
Measured: Baseline, Week 26
Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point)
Blood glucose (BG) self-monitored by subject at home; measured at least once between Visits 2, 3 and between Visits 8, 9 (8-point: fasting, pre-meal, post-meal, bedtime, 2:00 am); between each visit: Visit 3 to 8 (7-point: fasting, post-meal, pre-lunch, pre-dinner, bedtime). Post-meal: 2-hour period after breakfast, lunch, dinner. Change: average overall absolute, pre-meal, and post-meal blood glucose = HBGM at observation minus HBGM at baseline; pre-meal to post-meal blood glucose = HBGM at post-meal minus HBGM at pre-meal.
Measured: Baseline, Week 26
Number of Subjects With Hypoglycemic Events by Severity
Number of subjects with hypoglycemic events by severity. Severe hypoglycemia: subject unable to treat self; exhibits a neurological symptom; and blood glucose <=2.72 mmol/L or blood glucose not measured but symptoms reversed with food intake, SC glucagon, or intravenous glucose. If all 3 criteria not met, hypoglycemia defined as mild or moderate.
Measured: Week 26
Number of Events of Nocturnal Hypoglycemia
Number of events of nocturnal hypoglycemia, incidence: midnight to 6:00 am. Hypoglycemia: characteristic symptoms of hypoglycemia with no blood glucose check; resolved with food intake, SC glucagon, or intravenous (IV) glucose; or symptoms with glucose <3.27 mmol/L (59 mg/dL); or any glucose measurement <=2.72 mmol/L (49 mg/dl). Severity of nocturnal glycemia not summarized.
Measured: Week 26
Change From Baseline in Body Weight
Change from baseline calculated as body weight at observation minus body weight at baseline.
Measured: Baseline, Week 26
Change From Baseline in Body Mass Index (BMI)
BMI measured as kilograms per meter squared (kg/m2). Change calculated as BMI at observation minus BMI at baseline.
Measured: Baseline, Week 26
Number of Subjects Discontinued Due to Insufficient Clinical Response
Number of subjects discontinued due to signs and symptoms of persistent hyperglycemia or HbA1c > 12.0 % or frequent and unexplained severe hypoglycemic events (> 3 events per month for 2 or more months); subject's HbA1c not < = 7 % at Week 12.
Measured: Week 26
Continuous Glucose Monitoring System (CGMS) 24-hour Glucose Profile in a Subset of Patients
The mean of the 24-hour mean and the mean of the 24-hour standard deviation (SD) (variability around the average glucose concentration) calculated on glucose values (mg/dl) collected during inpatient evaluation of glycemic stability. Interstitial glucose assessed at 5 minute intervals starting pre-supper on Day 1 of evaluation; ending on Day 3 pre-breakfast. Analysis is on data generated between 6:00 am on Day 2 and 6:00 am on Day 3.
Measured: Baseline, Week 26
Change From Baseline in Cardiovascular (CV) Biomarkers - High Sensitive C-reactive Protein (Hs-CRP)
Change from baseline in CV biomarker hs-CRP (milligrams per deciliter [mg/dl]) calculated as hs-CRP at observation minus hs-CRP at baseline.
Measured: Baseline, Week 26
Change From Baseline in CV Biomarkers - Interleukin 6 (IL-6)
Change from baseline in IL-6 (picograms per milliliter [pg/ml]) calculated as IL-6 at observation minus IL-6 at baseline.
Measured: Baseline, Week 26
Change From Baseline in CV Biomarkers - Thrombin-antithrombin Complexes (Tat-complexes)
Change from baseline in tat-complexes (nanograms per milliliter [ng/ml]) calculated as tat-complexes at observation minus tat-complexes at baseline.
Measured: Baseline, Week 26
Change From Baseline in CV Biomarkers - Soluble Tissue Factor (STF)
Change from baseline in soluble tissue factor (pg/ml) calculated as STF at observation minus STF at baseline.
Measured: Baseline, Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2006 (estimated)
- Study startDec 2006
- Primary completionAug 2008
- Study completionAug 2008
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391027
- Sponsor's protocol ID
- A2171084
- Status last verified
- Jul 2025
- First submitted
- 19 Oct 2006
- Last updated
- 11 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Six Month, Open-Label Outpatient, Randomized Parallel Group Trial Assessing The Impact Of Dry Powder Inhaled Insulin (Exubera®) On Glycemic Control Compared To Insulin Glargine (Lantus®) In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combination Of Two Or More Oral Agents
- ClinicalTrials.gov ID
- NCT00391027
- Acronym / sponsor ID
- A2171084
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- type 2 diabetes, insulin, glycemic control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 23 Oct 2006 (estimated)
- Results
- Posted 21 Oct 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare efficacy and safety of Exubera® vs Lantus® in patients with type 2 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin Glargine (Lantus®) | Active comparator | Drug: Insulin Glargine (Lantus®) |
| Inhaled Human Insulin (Exubera®) | Active comparator | Drug: Inhaled Human Insulin (Exubera®) |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diabetes Mellitus, Type 2 on oral agents
- Age > 30 years
Key exclusion criteria (2 listed)
- Severe Asthma, severe Chronic Obstructive Pulmonary Disease
- 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 |
|---|---|---|
| Insulin Glargine (Lantus®)Patient will be randomized to Lantus® while remaining on pre-study oral hypoglycemic agents. | Drug | Insulin Glargine (Lantus®) |
| Inhaled Human Insulin (Exubera®)Patient will be randomized inhaled insulin while remaining on pre-study oral hypoglycemic agents. | Drug | Inhaled Human Insulin (Exubera®) |
Primary outcome
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
Time frame: Baseline, Week 26
Change (measured as percent): HbA1c at observation minus HbA1c at baseline. Primary objective to demonstrate non-inferiority of inhaled insulin compared to insulin glargine for glycemic control after 26 weeks of treatment not attainable due to early termination of study; analyses were descriptive and graphical.
16 secondary outcomes
Change From Baseline in HbA1c Prior to Week 26
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, and Week 18
Number of Subjects With HbA1c < 6.5 %
Time frame: Week 26
Number of Subjects With HbA1c < 7.0 %
Time frame: Week 26
Number of Subjects With HbA1c < 8.0 %
Time frame: Week 26
Change From Baseline in Fasting Plasma Glucose (FPG) Level
Time frame: Baseline, Week 26
Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point)
Time frame: Baseline, Week 26
Number of Subjects With Hypoglycemic Events by Severity
Time frame: Week 26
Number of Events of Nocturnal Hypoglycemia
Time frame: Week 26
Change From Baseline in Body Weight
Time frame: Baseline, Week 26
Change From Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 26
Number of Subjects Discontinued Due to Insufficient Clinical Response
Time frame: Week 26
Continuous Glucose Monitoring System (CGMS) 24-hour Glucose Profile in a Subset of Patients
Time frame: Baseline, Week 26
Change From Baseline in Cardiovascular (CV) Biomarkers - High Sensitive C-reactive Protein (Hs-CRP)
Time frame: Baseline, Week 26
Change From Baseline in CV Biomarkers - Interleukin 6 (IL-6)
Time frame: Baseline, Week 26
Change From Baseline in CV Biomarkers - Thrombin-antithrombin Complexes (Tat-complexes)
Time frame: Baseline, Week 26
Change From Baseline in CV Biomarkers - Soluble Tissue Factor (STF)
Time frame: Baseline, Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- 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
Recruiting
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Enrolling by invitation
MTM2MTG Pilot Ancillary Study
Diet, Healthy, HbA1c
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
Not yet recruitingPhase 1/2
A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
Cochlear Synaptopathy
Not yet recruitingPhase 1
A Research Study to Check the Safety of NNC9836-0001 When Given to Healthy Participants and Participants With Type 2 Diabetes
Diabetes Mellitus, Type 2
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
62 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin Glargine (Lantus®) and Inhaled Human Insulin (Exubera®) in people with Diabetes Mellitus, Type 2, run by Pfizer at 62 sites in 10 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 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in Sweden, Germany, Spain, France, Netherlands and 5 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 21 Oct 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?
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 (time frame: Baseline, Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2026.