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

Primary Purpose

Diabetes Mellitus

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Inhaled Insulin

Subcutaneous insulin

About this trial

This is an interventional treatment trial for Diabetes Mellitus

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Type 2 diabetes mellitus Exclusion Criteria: COPD Asthma Smoking Pregnancy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Inhaled Insulin

Subcutaneous insulin

Arm Description

Inhalable short-acting insulin

Outcomes

Primary Outcome Measures

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).

Change From Baseline in FEV1

Change from baseline: mean of (value of observed FEV1 [L] at treatment observation minus baseline value).

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).

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.

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).

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).

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.

Secondary Outcome Measures

Forced Vital Capacity (FVC)

Forced Vital Capacity (FVC) measured in liters (L).

Total Lung Capacity (TLC)

Total Lung Capacity measured in liters (L).

Change From Baseline in Glycosylated Hemoglobin (HbA1c)

Change from baseline: mean of (value of observed HbA1c [%] at treatment observation minus baseline value).

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).

Change From Baseline in Body Weight

Change from baseline: mean of (value of observed body weight [kilograms (kg)] at treatment observation minus baseline value).

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.

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.

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.

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).

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).

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).

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.

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.

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.

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.

High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Within Normal Limits

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).

Insulin Antibodies

Observed values for insulin antibodies measured as micro units per milliliter (microU/mL).

Full Information

NCT ID

NCT00136916

First Posted

August 25, 2005

Last Updated

February 12, 2010

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00136916

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Terminated

Why Stopped

See termination reason in detailed description.

Study Start Date

June 2002 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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®. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

635 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Inhaled Insulin

Arm Type

Experimental

Arm Description

Inhalable short-acting insulin

Arm Title

Subcutaneous insulin

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Inhaled Insulin

Other Intervention Name(s)

Exubera

Intervention Description

Inhaled insulin with dose adjusted according to premeal blood glucose

Intervention Type

Drug

Intervention Name(s)

Subcutaneous insulin

Intervention Description

Subcutaneous insulin with dose adjusted according to premeal blood glucose

Primary Outcome Measure Information:

Title

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

Description

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).

Time Frame

Month 3 through extension Month 60

Title

Change From Baseline in FEV1

Description

Change from baseline: mean of (value of observed FEV1 [L] at treatment observation minus baseline value).

Time Frame

Baseline through extension follow up Month 3

Title

Annual Rate of Change in FEV1

Description

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).

Time Frame

Week -2 through extension follow up Month 3 or end of study

Title

Summary of ≥ 15 % Decliners in FEV1

Description

Time Frame

Month 3 through extension follow up Month 3

Title

Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco)

Description

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).

Time Frame

Week -2 through extension follow up Month 3 or end of study

Title

Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)

Description

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).

Time Frame

Baseline through extension follow up Month 3

Title

Summary of ≥ 20 % Decliners in DLco

Description

Time Frame

Month 3 through extension follow up Month 3

Secondary Outcome Measure Information:

Title

Forced Vital Capacity (FVC)

Description

Forced Vital Capacity (FVC) measured in liters (L).

Time Frame

Week -3 through extension follow up Month 3 or end of study

Title

Total Lung Capacity (TLC)

Description

Total Lung Capacity measured in liters (L).

Time Frame

Baseline through extension follow up Month 3

Title

Change From Baseline in Glycosylated Hemoglobin (HbA1c)

Description

Change from baseline: mean of (value of observed HbA1c [%] at treatment observation minus baseline value).

Time Frame

Baseline through extension follow up Month 3

Title

Change From Baseline in Fasting Plasma Glucose (FPG)

Description

Change from baseline: mean of (value of observed FPG [milligrams per deciliter (mg/dL)] at treatment observation minus baseline value).

Time Frame

Baseline through extension follow up Month 3

Title

Change From Baseline in Body Weight

Description

Change from baseline: mean of (value of observed body weight [kilograms (kg)] at treatment observation minus baseline value).

Time Frame

Baseline through extension follow up Month 3

Title

Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)

Description

Time Frame

Month 3 through extension Month 36

Title

Total Daily Long-acting Insulin (Adjusted for Body Weight)

Description

Time Frame

Month 3 through extension Month 36

Title

Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)

Description

Time Frame

Month 3 through extension Month 36

Title

Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)

Description

Time Frame

Month 3 through extension Month 36

Title

Lipid Panel: Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, and Triglycerides

Description

Lipid values for total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), and triglycerides measured as milligrams per deciliter (mg/dL).

Time Frame

Week -4 through Month 24

Title

Hypoglycemic Event Rates

Description

Time Frame

Month 1 through extension Month 36

Title

Severe Hypoglycemic Event Rates

Description

Time Frame

Month 1 through extension Month 36

Title

Cough Questionnaire

Description

Time Frame

Week 0 and if indicated through extension follow up Month 3

Title

Baseline Dyspnea Index (BDI)

Description

Time Frame

Week -1

Title

Transition Dyspnea Index (TDI)

Description

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.

Time Frame

Week 4 through extension follow up Month 3 or end of study

Title

High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Within Normal Limits

Description

Time Frame

Baseline, M12, M24, Ext M6, Ext M18, Ext M36

Title

High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits

Description

Time Frame

Baseline, M12, M24, Ext M6, Ext M18, Ext M36

Title

Insulin Antibodies

Description

Observed values for insulin antibodies measured as micro units per milliliter (microU/mL).

Time Frame

Baseline through extension Month 36

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Type 2 diabetes mellitus Exclusion Criteria: COPD Asthma Smoking Pregnancy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85016

Country

United States

Facility Name

Pfizer Investigational Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85715

Country

United States

Facility Name

Pfizer Investigational Site

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Pfizer Investigational Site

City

Greenbrae

State/Province

California

ZIP/Postal Code

94904

Country

United States

Facility Name

Pfizer Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90073

Country

United States

Facility Name

Pfizer Investigational Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95816

Country

United States

Facility Name

Pfizer Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Pfizer Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

Pfizer Investigational Site

City

San Luis Obispo

State/Province

California

ZIP/Postal Code

93401

Country

United States

Facility Name

Pfizer Investigational Site

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

Facility Name

Pfizer Investigational Site

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Pfizer Investigational Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80209

Country

United States

Facility Name

Pfizer Investigational Site

City

Hamden

State/Province

Connecticut

ZIP/Postal Code

06518

Country

United States

Facility Name

Pfizer Investigational Site

City

Madison

State/Province

Connecticut

ZIP/Postal Code

06443

Country

United States

Facility Name

Pfizer Investigational Site

City

New Britain

State/Province

Connecticut

ZIP/Postal Code

06050

Country

United States

Facility Name

Pfizer Investigational Site

City

Waterbury

State/Province

Connecticut

ZIP/Postal Code

06708

Country

United States

Facility Name

Pfizer Investigational Site

City

Chiefland

State/Province

Florida

ZIP/Postal Code

32626

Country

United States

Facility Name

Pfizer Investigational Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33761

Country

United States

Facility Name

Pfizer Investigational Site

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33901

Country

United States

Facility Name

Pfizer Investigational Site

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Facility Name

Pfizer Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33156

Country

United States

Facility Name

Pfizer Investigational Site

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

Pfizer Investigational Site

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

34684

Country

United States

Facility Name

Pfizer Investigational Site

City

Tallahassee

State/Province

Florida

ZIP/Postal Code

32308

Country

United States

Facility Name

Pfizer Investigational Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

Pfizer Investigational Site

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96813

Country

United States

Facility Name

Pfizer Investigational Site

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96814

Country

United States

Facility Name

Pfizer Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60602

Country

United States

Facility Name

Pfizer Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60607

Country

United States

Facility Name

Pfizer Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60610

Country

United States

Facility Name

Pfizer Investigational Site

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62704

Country

United States

Facility Name

Pfizer Investigational Site

City

Wilmette

State/Province

Illinois

ZIP/Postal Code

60091

Country

United States

Facility Name

Pfizer Investigational Site

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

Facility Name

Pfizer Investigational Site

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20817

Country

United States

Facility Name

Pfizer Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Pfizer Investigational Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48106

Country

United States

Facility Name

Pfizer Investigational Site

City

Bloomfield Hills

State/Province

Michigan

ZIP/Postal Code

48302

Country

United States

Facility Name

Pfizer Investigational Site

City

Plymouth

State/Province

Michigan

ZIP/Postal Code

48170

Country

United States

Facility Name

Pfizer Investigational Site

City

Royal Oak

State/Province

Michigan

ZIP/Postal Code

48073

Country

United States

Facility Name

Pfizer Investigational Site

City

Southfield

State/Province

Michigan

ZIP/Postal Code

48034

Country

United States

Facility Name

Pfizer Investigational Site

City

Chesterfield

State/Province

Missouri

ZIP/Postal Code

63017

Country

United States

Facility Name

Pfizer Investigational Site

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Pfizer Investigational Site

City

Butte

State/Province

Montana

ZIP/Postal Code

59701

Country

United States

Facility Name

Pfizer Investigational Site

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68521

Country

United States

Facility Name

Pfizer Investigational Site

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89014

Country

United States

Facility Name

Pfizer Investigational Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87108

Country

United States

Facility Name

Pfizer Investigational Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87109

Country

United States

Facility Name

Pfizer Investigational Site

City

Mineola

State/Province

New York

ZIP/Postal Code

11501

Country

United States

Facility Name

Pfizer Investigational Site

City

New Hyde Park

State/Province

New York

ZIP/Postal Code

11042

Country

United States

Facility Name

Pfizer Investigational Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14609

Country

United States

Facility Name

Pfizer Investigational Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27713

Country

United States

Facility Name

Pfizer Investigational Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Pfizer Investigational Site

City

Mansfield

State/Province

Ohio

ZIP/Postal Code

44903

Country

United States

Facility Name

Pfizer Investigational Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74104

Country

United States

Facility Name

Pfizer Investigational Site

City

Warwick

State/Province

Rhode Island

ZIP/Postal Code

02886

Country

United States

Facility Name

Pfizer Investigational Site

City

Beaumont

State/Province

Texas

ZIP/Postal Code

77701

Country

United States

Facility Name

Pfizer Investigational Site

City

Beaumont

State/Province

Texas

ZIP/Postal Code

77706

Country

United States

Facility Name

Pfizer Investigational Site

City

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78411

Country

United States

Facility Name

Pfizer Investigational Site

City

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78412

Country

United States

Facility Name

Pfizer Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Pfizer Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Pfizer Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Pfizer Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77079

Country

United States

Facility Name

Pfizer Investigational Site

City

Irving

State/Province

Texas

ZIP/Postal Code

75061

Country

United States

Facility Name

Pfizer Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Pfizer Investigational Site

City

Burlington

State/Province

Vermont

ZIP/Postal Code

05401

Country

United States

Facility Name

Pfizer Investigational Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23225

Country

United States

Facility Name

Pfizer Investigational Site

City

Renton

State/Province

Washington

ZIP/Postal Code

98055

Country

United States

Facility Name

Pfizer Investigational Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53209

Country

United States

Facility Name

Pfizer Investigational Site

City

Porto Alegre

State/Province

ZIP/Postal Code

90035-170

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Sao Paulo

State/Province

ZIP/Postal Code

01244-030

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2T 5C7

Country

Canada

Facility Name

Pfizer Investigational Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T3B 0M3

Country

Canada

Facility Name

Pfizer Investigational Site

City

Red Deer

State/Province

Alberta

ZIP/Postal Code

T4N 6V7

Country

Canada

Facility Name

Pfizer Investigational Site

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8R 1J8

Country

Canada

Facility Name

Pfizer Investigational Site

City

Winnepeg

State/Province

Manitoba

ZIP/Postal Code

R3A 1R9

Country

Canada

Facility Name

Pfizer Investigational Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3E 3P4

Country

Canada

Facility Name

Pfizer Investigational Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 1V7

Country

Canada

Facility Name

Pfizer Investigational Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

Pfizer Investigational Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4V2

Country

Canada

Facility Name

Pfizer Investigational Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 1A2

Country

Canada

Facility Name

Pfizer Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N-3M5

Country

Canada

Facility Name

Pfizer Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X5

Country

Canada

Facility Name

Pfizer Investigational Site

City

Laval

State/Province

Quebec

ZIP/Postal Code

H7T 2P5

Country

Canada

Facility Name

Pfizer Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 2M4

Country

Canada

Facility Name

Pfizer Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 1A1

Country

Canada

Facility Name

Pfizer Investigational Site

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7N 0W8

Country

Canada

Facility Name

Pfizer Investigational Site

City

Aguas Buenas

ZIP/Postal Code

00703

Country

Puerto Rico

Facility Name

Pfizer Investigational Site

City

Anasco

ZIP/Postal Code

00610

Country

Puerto Rico

Facility Name

Pfizer Investigational Site

City

Cabo Rojo

ZIP/Postal Code

00623

Country

Puerto Rico

Facility Name

Pfizer Investigational Site

City

San Juan

ZIP/Postal Code

00909

Country

Puerto Rico

Facility Name

Pfizer Investigational Site

City

San Juan

ZIP/Postal Code

00921

Country

Puerto Rico

12. IPD Sharing Statement

Citations:

PubMed Identifier

19905885

Citation

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.

Results Reference

derived

PubMed Identifier

18535196

Citation

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.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2171029&StudyName=Efficacy%20and%20Safety%20of%20Inhaled%20Insulin%20Compared%20with%20Subcutaneous%20Human%20Insulin%20Therapy%20in%20Adults%20with%20Type%202%20Diabetes

Description

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Learn more about this trial

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

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

Diabetes Mellitus

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial