Diabetes MellitusPhase 3NCT00136916

Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 2 Diabetes

A Phase 3 study testing Inhaled Insulin and Subcutaneous insulin in people with Diabetes Mellitus, run by Pfizer at 92 sites in 4 countries.

Terminated

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

Official record

Search all trials

Trial summary

This study is being done to find out the good and bad effects of inhaled insulin that is used by oral inhalation, to adult males and females with type 2 diabetes mellitus. The other name for this inhaled insulin is Exubera®. Read more about this study

Who is it for?: Ages 35 to 75 years
Conditions the study is for: Diabetes Mellitus
What is being tested?: Inhaled Insulin and Subcutaneous insulin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 635 participants
Where: 92 sitesin 4 countries
Study dates: Jun 2002to Dec 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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetes mellitus

Who cannot join

COPD
Asthma
Smoking Pregnancy

Trial locations and contacts

92 sites in 4 countries.

Country

City, postcode or hospital

92 sites in 4 countries

United States69 sites

Pfizer Investigational Site
Albuquerque, New Mexico, 87108
Pfizer Investigational Site
Albuquerque, New Mexico, 87109
Pfizer Investigational Site
Ann Arbor, Michigan, 48106
Pfizer Investigational Site
Beaumont, Texas, 77701
Pfizer Investigational Site
Beaumont, Texas, 77706
Pfizer Investigational Site
Bethesda, Maryland, 20817
Pfizer Investigational Site
Bloomfield Hills, Michigan, 48302
Pfizer Investigational Site
Boston, Massachusetts, 02215
Pfizer Investigational Site
Burlington, Vermont, 05401
Pfizer Investigational Site
Butte, Montana, 59701
Pfizer Investigational Site
Chesterfield, Missouri, 63017
Pfizer Investigational Site
Chicago, Illinois, 60602
Pfizer Investigational Site
Chicago, Illinois, 60607
Pfizer Investigational Site
Chicago, Illinois, 60610
Pfizer Investigational Site
Chiefland, Florida, 32626
Pfizer Investigational Site
Clearwater, Florida, 33761
Pfizer Investigational Site
Corpus Christi, Texas, 78411
Pfizer Investigational Site
Corpus Christi, Texas, 78412
Pfizer Investigational Site
Dallas, Texas, 75230
Pfizer Investigational Site
Dallas, Texas, 75231
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Denver, Colorado, 80209
Pfizer Investigational Site
Durham, North Carolina, 27713
Pfizer Investigational Site
Fort Myers, Florida, 33901
Pfizer Investigational Site
Fresno, California, 93720
Pfizer Investigational Site
Greenbrae, California, 94904
Pfizer Investigational Site
Hamden, Connecticut, 06518
Pfizer Investigational Site
Henderson, Nevada, 89014
Pfizer Investigational Site
Hollywood, Florida, 33021
Pfizer Investigational Site
Honolulu, Hawaii, 96813
Pfizer Investigational Site
Honolulu, Hawaii, 96814
Pfizer Investigational Site
Houston, Texas, 77079
Pfizer Investigational Site
Irving, Texas, 75061
Pfizer Investigational Site
Lincoln, Nebraska, 68521
Pfizer Investigational Site
Los Angeles, California, 90073
Pfizer Investigational Site
Madison, Connecticut, 06443
Pfizer Investigational Site
Mansfield, Ohio, 44903
Pfizer Investigational Site
Miami, Florida, 33156
Pfizer Investigational Site
Milwaukee, Wisconsin, 53209
Pfizer Investigational Site
Mineola, New York, 11501
Pfizer Investigational Site
New Britain, Connecticut, 06050
Pfizer Investigational Site
New Hyde Park, New York, 11042
Pfizer Investigational Site
New Orleans, Louisiana, 70112
Pfizer Investigational Site
Ocala, Florida, 34471
Pfizer Investigational Site
Palm Harbor, Florida, 34684
Pfizer Investigational Site
Phoenix, Arizona, 85016
Pfizer Investigational Site
Plymouth, Michigan, 48170
Pfizer Investigational Site
Renton, Washington, 98055
Pfizer Investigational Site
Richmond, Virginia, 23225
Pfizer Investigational Site
Rochester, New York, 14609
Pfizer Investigational Site
Royal Oak, Michigan, 48073
Pfizer Investigational Site
Sacramento, California, 95816
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Diego, California, 92103
Pfizer Investigational Site
San Diego, California, 92108
Pfizer Investigational Site
San Luis Obispo, California, 93401
Pfizer Investigational Site
Southfield, Michigan, 48034
Pfizer Investigational Site
Springfield, Illinois, 62704
Pfizer Investigational Site
St Louis, Missouri, 63141
Pfizer Investigational Site
Tallahassee, Florida, 32308
Pfizer Investigational Site
Tucson, Arizona, 85715
Pfizer Investigational Site
Tulsa, Oklahoma, 74104
Pfizer Investigational Site
Tustin, California, 92780
Pfizer Investigational Site
Walnut Creek, California, 94598
Pfizer Investigational Site
Warwick, Rhode Island, 02886
Pfizer Investigational Site
Waterbury, Connecticut, 06708
Pfizer Investigational Site
West Palm Beach, Florida, 33401
Pfizer Investigational Site
Wilmette, Illinois, 60091
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

Canada16 sites

Pfizer Investigational Site
Calgary, Alberta, T2T 5C7
Pfizer Investigational Site
Calgary, Alberta, T3B 0M3
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 1V7
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 2Y9
Pfizer Investigational Site
Laval, Quebec, H7T 2P5
Pfizer Investigational Site
London, Ontario, N6A 4V2
Pfizer Investigational Site
Montreal, Quebec, H1T 2M4
Pfizer Investigational Site
Montreal, Quebec, H3A 1A1
Pfizer Investigational Site
Ottawa, Ontario, K1H 1A2
Pfizer Investigational Site
Red Deer, Alberta, T4N 6V7
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7N 0W8
Pfizer Investigational Site
Toronto, Ontario, M4N-3M5
Pfizer Investigational Site
Toronto, Ontario, M5G 1X5
Pfizer Investigational Site
Victoria, British Columbia, V8R 1J8
Pfizer Investigational Site
Winnepeg, Manitoba, R3A 1R9
Pfizer Investigational Site
Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

Puerto Rico5 sites

Pfizer Investigational Site
Aguas Buenas, 00703
Pfizer Investigational Site
Anasco, 00610
Pfizer Investigational Site
Cabo Rojo, 00623
Pfizer Investigational Site
San Juan, 00909
Pfizer Investigational Site
San Juan, 00921

Other trials in Puerto Rico

Brazil2 sites

Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-170
Pfizer Investigational Site
São Paulo, São Paulo, 01244-030

Other trials in Brazil

About this study

Official title: Efficacy and Safety of Exubera® (Inhaled Insulin) Compared With Subcutaneous Human Insulin Therapy in Adult Subjects With Type 2 Diabetes Mellitus: A Long-Term, Outpatient, Open-Label, Parallel-Group Comparative Trial

This study included a 2-year comparative treatment period followed by a 6-month follow-up period during which inhaled insulin-treated subjects were switched back to subcutaneous short-acting insulin. After this follow-up period, all eligible subjects entered a comparative extension period that was to last for 5 years. When the comparative portion of the study was terminated, all subjects were requested to return for a final extension follow-up month 3 visit.

Read the detailed description

Pfizer announced in October 2007 that it would stop marketing Exubera. Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera. As a result, study A2171029 was terminated on June 9, 2008. Neither safety nor efficacy reasons were the cause of the study termination.

Conditions: Diabetes Mellitus
Being tested: Inhaled Insulin, Subcutaneous 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
Also called Exubera
Inhaled insulin with dose adjusted according to premeal blood glucose
Subcutaneous insulinDrug
Subcutaneous insulin with dose adjusted according to premeal blood glucose

Study groups in NCT00136916
Study group	Role	What they receive
Inhaled Insulin	Experimental	Inhalable short-acting insulin Receives: Drug: Inhaled Insulin
Subcutaneous insulin	Active comparator	Not described Receives: Drug: Subcutaneous insulin

What is being measured

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

Change From Month 3 in Forced Expiratory Volume in 1 Second (FEV1)
Change from Month 3: mean of (value of observed FEV1 [forced expiratory volume in the first second of forced exhalation] in liters [L] at treatment observation minus Month 3 value).
Measured: Month 3 through extension Month 60
Change From Baseline in FEV1
Change from baseline: mean of (value of observed FEV1 [L] at treatment observation minus baseline value).
Measured: Baseline through extension follow up Month 3
Annual Rate of Change in FEV1
Annual rate of change in FEV1 calculated as slope over time [visit] for forced expiratory volume in 1 second measured as liters per year (L/yr).
Measured: Week -2 through extension follow up Month 3 or end of study
Summary of ≥ 15 % Decliners in FEV1
Number of subjects with a post-baseline FEV1 decrease of ≥ 15 % [(baseline observed value - visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrrent illness, a repeat FEV1 was performed.
Measured: Month 3 through extension follow up Month 3
Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco)
Annual rate of change in DLco calculated as slope over time (visit) measured as milliliters per minute per millimeters of mercury per year (ml/min/mmHg/yr).
Measured: Week -2 through extension follow up Month 3 or end of study
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Change from baseline: mean of (value of observed DLco [milliliters per minute per millimeters of mercury (ml/min/mmHg)] at treatment observation minus baseline value).
Measured: Baseline through extension follow up Month 3
Summary of ≥ 20 % Decliners in DLco
Number of subjects with a post-baseline DLco decrease of ≥ 20 % [(baseline observed value - visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrrent illness, a repeat DLco was performed.
Measured: Month 3 through extension follow up Month 3

Secondary outcomes (18)

Forced Vital Capacity (FVC)
Forced Vital Capacity (FVC) measured in liters (L).
Measured: Week -3 through extension follow up Month 3 or end of study
Total Lung Capacity (TLC)
Total Lung Capacity measured in liters (L).
Measured: Baseline through extension follow up Month 3
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Change from baseline: mean of (value of observed HbA1c [%] at treatment observation minus baseline value).
Measured: Baseline through extension follow up Month 3
Change From Baseline in Fasting Plasma Glucose (FPG)
Change from baseline: mean of (value of observed FPG [milligrams per deciliter (mg/dL)] at treatment observation minus baseline value).
Measured: Baseline through extension follow up Month 3
Change From Baseline in Body Weight
Change from baseline: mean of (value of observed body weight [kilograms (kg)] at treatment observation minus baseline value).
Measured: Baseline through extension follow up Month 3
Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)
Total daily long-acting insulin dose unadjusted for body weight. Long-acting (units) insulin for inhaled insulin and subcutaneous treatment groups included NPH insulin, Ultralente®, and insulin glargine.
Measured: Month 3 through extension Month 36
Total Daily Long-acting Insulin (Adjusted for Body Weight)
Total daily dose of long-acting insulin adjusted for body weight (units per kilogram [kg]). Long-acting (units) insulin for inhaled insulin and subcutaneous treatment groups included NPH insulin, Ultralente®, and insulin glargine.
Measured: Month 3 through extension Month 36
Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)
Total daily dose of short-acting insulin unadjusted for body weight. Short-acting insulin (milligrams [mg]) for the inhaled insulin treatment group was inhaled insulin; short-acting insulin (units) for the subcutaneous insulin treatment group included insulin lispro, insulin aspart, and regular insulin.
Measured: Month 3 through extension Month 36
Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)
Total daily dose of short-acting insulin adjusted for body weight. Short-acting insulin (mg) for the inhaled insulin treatment group was inhaled insulin (mg divided by kg); short-acting insulin (units) for the subcutaneous insulin treatment group included insulin lispro, insulin aspart, and regular insulin (units divided by kg).
Measured: Month 3 through extension Month 36
Lipid Panel: Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, and Triglycerides
Lipid values for total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), and triglycerides measured as milligrams per deciliter (mg/dL).
Measured: Week -4 through Month 24
Hypoglycemic Event Rates
Hypoglycemic event rate; hypoglycemic event identified by characteristic symptoms of hypoglycemia with no blood glucose (BG) check with prompt resolution with food intake, SC glucagon, or intravenous (IV) glucose; characteristic symptoms with BG of 59 mg/dL (3.2 mmol/L) or less with or without symptoms. Crude event rate = total events divided by subject months (elapsed number of months a subject was in the study at each time interval).
Measured: Month 1 through extension Month 36
Severe Hypoglycemic Event Rates
Severe hypoglycemic event rate; all 3 criteria were met: subject unable to treat self, exhibited at least 1 neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty awakening, suspected seizure, loss of consciousness); BG measurement ≤49 mg/dL, or not measured but clinical manifestations reversed by oral carbohydrates, SC glucagon, or IV glucose. Crude event rate: total events divided by subject months multiplied by 100 ([total events/subject months]*100). Subjects months: elapsed number of months subject was in study in each time interval.
Measured: Month 1 through extension Month 36
Cough Questionnaire
Clinician administered 6 question instrument to measure cough frequency (night, day), severity, timing in relation to short-acting insulin dosing, severity related to insulin dosing (SC or inhaled), and productivity of cough; range 0 (indicates no symptoms) to 4 (indicates severe symptoms). Questionnaire administered at Week 0 then if and only if, cough is identified as an adverse event not explained by a concomitant condition, such as an upper respiratory tract infection.
Measured: Week 0 and if indicated through extension follow up Month 3
Baseline Dyspnea Index (BDI)
Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort. BDI score range 0 (very severe impairment) to 4 (no impairment) scaled to a BDI focal score (0-12). Lower score indicates greater impairment.
Measured: Week -1
Transition Dyspnea Index (TDI)
Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort. TDI score range -3 (major deterioration) to +3 (major improvement); sum of all domains yields the TDI focal score (-9 to +9); lower score indicates greater deterioration. Compared to previous scoring to determine deterioration or improvement.
Measured: Week 4 through extension follow up Month 3 or end of study
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Within Normal Limits
Number of subjects with Yes or No responses (within normal limits at specified time points = Yes or not within normal limits at specified time points = No) at observation when HRCT of thorax was within normal limits at baseline.
Measured: Baseline, M12, M24, Ext M6, Ext M18, Ext M36
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
Number of subjects with Yes or No responses (within normal limits at specified time points = Yes or not within normal limits at specified time points = No) at observation when HRCT of thorax was not within normal limits at baseline. "No" response at observation further categorized as no significant change (NSC), more abnormal (> Abn), or less abnormal (< Abn).
Measured: Baseline, M12, M24, Ext M6, Ext M18, Ext M36
Insulin Antibodies
Observed values for insulin antibodies measured as micro units per milliliter (microU/mL).
Measured: Baseline through extension Month 36

Timeline

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

Jun 2002Dec 2008

First posted29 Aug 2005 (estimated)
Study startJun 2002
Primary completionDec 2008
Study completionDec 2008

Why it stopped: See termination reason in detailed description.

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.
Publications (2)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: 635 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00136916
Sponsor's protocol ID: A2171029
Status last verified: Dec 2009
First submitted: 25 Aug 2005
Last updated: 18 Feb 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Rosenstock J, Cefalu WT, Hollander PA, Klioze SS, Reis J, Duggan WT. Safety and efficacy of inhaled human insulin (exubera) during discontinuation and readministration of therapy in adults with type 2 diabetes: a 3-year randomized controlled trial. Diabetes Technol Ther. 2009 Nov;11(11):697-705. doi: 10.1089/dia.2009.0062.
PubMed 19905885
Rosenstock J, Cefalu WT, Hollander PA, Belanger A, Eliaschewitz FG, Gross JL, Klioze SS, St Aubin LB, Foyt H, Ogawa M, Duggan WT. Two-year pulmonary safety and efficacy of inhaled human insulin (Exubera) in adult patients with type 2 diabetes. Diabetes Care. 2008 Sep;31(9):1723-8. doi: 10.2337/dc08-0159. Epub 2008 Jun 5.
PubMed 18535196

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

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Exubera® (Inhaled Insulin) Compared With Subcutaneous Human Insulin Therapy in Adult Subjects With Type 2 Diabetes Mellitus: A Long-Term, Outpatient, Open-Label, Parallel-Group Comparative Trial
ClinicalTrials.gov ID: NCT00136916
Acronym / sponsor ID: A2171029
Conditions: Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: See termination reason in detailed description.
Enrolment: 635 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jun 2002
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 29 Aug 2005 (estimated)
Results: Posted 18 Jan 2010

Clinical summary

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

Detailed description

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 InsulinInhalable short-acting insulin
Subcutaneous insulin	Active comparator	Drug: Subcutaneous insulin

Who may qualify

Ages: 35 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Type 2 diabetes mellitus

Key exclusion criteria (3 listed)

COPD
Asthma
Smoking Pregnancy

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 InsulinAlso: ExuberaInhaled insulin with dose adjusted according to premeal blood glucose	Drug	Inhaled Insulin
Subcutaneous insulinSubcutaneous insulin with dose adjusted according to premeal blood glucose	Drug	Subcutaneous insulin

Primary outcome

Change From Month 3 in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Month 3 through extension Month 60
Change from Month 3: mean of (value of observed FEV1 [forced expiratory volume in the first second of forced exhalation] in liters [L] at treatment observation minus Month 3 value).
Change From Baseline in FEV1
Time frame: Baseline through extension follow up Month 3
Change from baseline: mean of (value of observed FEV1 [L] at treatment observation minus baseline value).
Annual Rate of Change in FEV1
Time frame: Week -2 through extension follow up Month 3 or end of study
Annual rate of change in FEV1 calculated as slope over time [visit] for forced expiratory volume in 1 second measured as liters per year (L/yr).
Summary of ≥ 15 % Decliners in FEV1
Time frame: Month 3 through extension follow up Month 3
Number of subjects with a post-baseline FEV1 decrease of ≥ 15 % [(baseline observed value - visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrrent illness, a repeat FEV1 was performed.
Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco)
Time frame: Week -2 through extension follow up Month 3 or end of study
Annual rate of change in DLco calculated as slope over time (visit) measured as milliliters per minute per millimeters of mercury per year (ml/min/mmHg/yr).
Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)
Time frame: Baseline through extension follow up Month 3
Change from baseline: mean of (value of observed DLco [milliliters per minute per millimeters of mercury (ml/min/mmHg)] at treatment observation minus baseline value).
Summary of ≥ 20 % Decliners in DLco
Time frame: Month 3 through extension follow up Month 3
Number of subjects with a post-baseline DLco decrease of ≥ 20 % [(baseline observed value - visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrrent illness, a repeat DLco was performed.

18 secondary outcomes

Forced Vital Capacity (FVC)
Time frame: Week -3 through extension follow up Month 3 or end of study
Total Lung Capacity (TLC)
Time frame: Baseline through extension follow up Month 3
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline through extension follow up Month 3
Change From Baseline in Fasting Plasma Glucose (FPG)
Time frame: Baseline through extension follow up Month 3
Change From Baseline in Body Weight
Time frame: Baseline through extension follow up Month 3
Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)
Time frame: Month 3 through extension Month 36
Total Daily Long-acting Insulin (Adjusted for Body Weight)
Time frame: Month 3 through extension Month 36
Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)
Time frame: Month 3 through extension Month 36
Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)
Time frame: Month 3 through extension Month 36
Lipid Panel: Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, and Triglycerides
Time frame: Week -4 through Month 24
Hypoglycemic Event Rates
Time frame: Month 1 through extension Month 36
Severe Hypoglycemic Event Rates
Time frame: Month 1 through extension Month 36
Cough Questionnaire
Time frame: Week 0 and if indicated through extension follow up Month 3
Baseline Dyspnea Index (BDI)
Time frame: Week -1
Transition Dyspnea Index (TDI)
Time frame: Week 4 through extension follow up Month 3 or end of study
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Within Normal Limits
Time frame: Baseline, M12, M24, Ext M6, Ext M18, Ext M36
High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits
Time frame: Baseline, M12, M24, Ext M6, Ext M18, Ext M36
Insulin Antibodies
Time frame: Baseline through extension Month 36

Results and safety

Results posted to the registry on 18 Jan 2010, 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 (Exubera®)	319	194
Subcutaneous Insulin	316	212

Primary outcome: Change From Month 3 in Forced Expiratory Volume in 1 Second (FEV1)

Time frame: Month 3 through extension Month 60. Mean (Standard Deviation). Unit: L

Population analysed: Full analysis set (FAS) FEV1: received at least 1 dose treatment, had baseline and at least 1 post-baseline FEV1. Due to study termination, originally planned inferential analysis for change from Month 3 through extension Month 60 was not done. Cross reference outcome measure: change from baseline in FEV1.

Primary outcome: Change From Baseline in FEV1

Time frame: Baseline through extension follow up Month 3. Mean (Standard Deviation). Unit: L

Measure	Inhaled Insulin (Exubera®) n = 311	Subcutaneous Insulin n = 304
Baseline (n=311, 304)	2.91 (0.68)	2.93 (0.71)
Month 3 (M3) (n=290, 291)	-0.06 (0.13)	-0.01 (0.15)
M6 (n=281, 280)	-0.05 (0.16)	-0.05 (0.17)
M9 (n=266, 276)	-0.08 (0.17)	-0.07 (0.16)
M12 (n=259, 263)	-0.09 (0.17)	-0.07 (0.16)
M15 (n=247, 250)	-0.12 (0.18)	-0.09 (0.17)
M18 (n=237, 236)	-0.12 (0.18)	-0.10 (0.18)
M21 (n=232, 233)	-0.13 (0.18)	-0.11 (0.18)

Inhaled Insulin (Exubera®) vs Subcutaneous Insulin: Mean Difference (Final Values): -0.045 (90% CI -0.064 to -0.026)
Inhaled Insulin (Exubera®) vs Subcutaneous Insulin: Mean Difference (Final Values): -0.003 (90% CI -0.025 to 0.020)
Inhaled Insulin (Exubera®) vs Subcutaneous Insulin: Mean Difference (Final Values): -0.010 (90% CI -0.033 to 0.013)

Population analysed: FAS FEV1; extension Month 36 (M36) Last Observation Carried Forward (LOCF) based on data in the extension phase only; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. Cross reference outcome measure: change from Month 3 in forced expiratory volume in 1 second.

Primary outcome: Annual Rate of Change in FEV1

Time frame: Week -2 through extension follow up Month 3 or end of study. Mean (Standard Deviation). Unit: L/yr

Population analysed: FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of Annual rate of change in FEV1 were not summarized as planned.

Primary outcome: Summary of ≥ 15 % Decliners in FEV1

Time frame: Month 3 through extension follow up Month 3. Number. Unit: participants

Measure	Inhaled Insulin (Exubera®) n = 311	Subcutaneous Insulin n = 304
M3 (n=290, 291)	2	2
M6 (n=281, 280)	3	4
M9 (n=266, 276)	7	5
M12 (n=259, 263)	7	4
M15 (n=247, 250)	13	6
M18 (n=237, 236)	10	8
M21 (n=232, 233)	12	8
M24 (n=223, 226)	14	13

Population analysed: FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.

18 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Inhaled Insulin (Exubera®)	76 of 316 (24.1%)	308 of 316 (97.5%)	Not reported
Subcutaneous Insulin	76 of 311 (24.4%)	301 of 311 (96.8%)	Not reported

Limitations and caveats (from the sponsor): Due to early termination of study, none of the subjects completed the study as planned. Subjects active at the time of study termination completed an end-of-study assessment and a 3-month follow-up visit.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 19905885Rosenstock J, Cefalu WT, Hollander PA, Klioze SS, Reis J, Duggan WT. Safety and efficacy of inhaled human insulin (exubera) during discontinuation and readministration of therapy in adults with type 2 diabetes: a 3-year randomized controlled trial. Diabetes Technol Ther. 2009 Nov;11(11):697-705. doi: 10.1089/dia.2009.0062.
Derived from this study: PubMed 18535196Rosenstock J, Cefalu WT, Hollander PA, Belanger A, Eliaschewitz FG, Gross JL, Klioze SS, St Aubin LB, Foyt H, Ogawa M, Duggan WT. Two-year pulmonary safety and efficacy of inhaled human insulin (Exubera) in adult patients with type 2 diabetes. Diabetes Care. 2008 Sep;31(9):1723-8. doi: 10.2337/dc08-0159. Epub 2008 Jun 5.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

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

92 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Inhaled Insulin and Subcutaneous insulin in people with Diabetes Mellitus, run by Pfizer at 92 sites in 4 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 1 inclusion and 3 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 18 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States, Canada, Puerto Rico, Brazil. 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 18 Jan 2010). 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 Month 3 in Forced Expiratory Volume in 1 Second (FEV1) (time frame: Month 3 through extension Month 60). The study lists 7 primary outcomes in all. 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 NCT00136916, which also lists 2 linked publications.

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 18 Feb 2010.