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A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With COPD

Primary Purpose

Diabetes Mellitus, Chronic Obstructive Pulmonary Disease

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Subcutaneous Insulin

Inhaled Insulin

About this trial

This is an interventional treatment trial for Diabetes Mellitus

Eligibility Criteria

30 Years - 77 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diabetes Mellitus (Type 1 or Type 2) currently controlled with injected insulin Prior smokers with a fixed airflow obstruction at screening (FEV1/FVC < 70%) and FEV1 < 80% predicted and/or a history of chronic productive cough. Exclusion Criteria: Poorly controlled, unstable or steroid-dependent COPD, insulin pump therapy, active smoking

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Subcutaneous Insulin

Inhaled Insulin

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

FEV1 was measured in liters (L) 30 minutes following the administration of ipratropium. Change from baseline: mean of (value of observed FEV1 (L) at treatment duration minus baseline value).

Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusion Capacity (DLco)

DLco measured in milliters/minutes/millimeters of mercury (mL/min/mmHg) 30 minutes following the administration of ipratropium. Change from baseline: mean of (value of observed DLco (mL/min/mmHg) at treatment duration minus baseline value).

Secondary Outcome Measures

Full Pulmonary Function Tests (PFTs) (Spirometry, Pre-Ipratropium and Pre-Insulin PFTs)

Full PFTs included spirometry pre- and 30-minutes post-ipratropium and were completed between the hours of 6 AM and 10 AM with subjects in the fasting state. Full PFT data were collected, but not analyzed.

Full PFTs (DLco, Pre-Ipratropium and Pre- Insulin PFTs)

Full PFTs included DLco pre- and 30-minutes post-ipratropium and were completed between the hours of 6 AM and 10 AM with subjects in the fasting state. Full PFT data were collected, but not analyzed.

Other PFTs (Besides FEV1 and DLco)

Other PFTs (besides FEV1 and DLco) were measured 30 minutes following the administration of ipratropium. Other PFTs included forced vital capacity (FVC), peak expiratory flow rate (maximal forced expiratory flow) (PEFR[FEFmax]), and forced expiratory flow from 25% to 75% of vital capacity (FEF25%-75%). Other PFT data were collected, but not analyzed.

Bronchodilator Responsiveness as Determined by the Change in FEV1

Responsiveness was the percent change from the FEV1 value before bronchodilator use to the FEV1 value 30 minutes after bronchodilator use, operationally defined as [(post-bronchodilator FEV1 minus pre-bronchodilator FEV1 divided by pre-bronchodilator FEV1] multiplied by 100.

Insulin Dose Responsiveness for FEV1

FEV1 dose responsiveness 10 and 60 minutes after insulin. FEV1 dose-responsiveness to insulin (defined as the difference between the FEV1 value following a dose of insulin and FEV1 value before a dose of insulin, operationally defined as the post-dose FEV1 value minus pre-dose FEV1 value).

Insulin Dose Responsiveness for DLco

DLco dose responsivness 10 and 60 minutes after insulin. DLco dose-responsiveness to insulin (defined as the difference between the DLco value following a dose of insulin and DLco value before a dose of insulin, operationally defined as the post-dose DLco value minus pre-dose DLco value).

Methacholine PC20

Methacholine challenge testing was conducted at selected sites at visits which did not occur at other sites (Weeks -2.9, -0.9, 11, 50 and 52+5). Methacholine challenge was not analyzed as there was only 1 test performed, which was a baseline test, and no methacholine tests performed in subjects using inhaled insulin.

Mean Weekly Number of Puffs of Short-Acting Bronchodilator Used

All subjects used diary cards to record their daily use of short-acting bronchodilators. Subjects recorded the sum of their short-acting bronchodilator use (puffs of albuterol plus ipratropium plus Combivent®, as applicable) daily, immediately upon arising, and again in the evening or before bed. Mean weekly number of puffs of short-acting bronchodilator used data were collected, but not analyzed.

Incidence of Non-Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

Non-severe COPD exacerbation = additional therapy (systemic corticosteroids, antibiotics, oxygen) needed for worsening respiratory symptoms and/or lung function, not needing hospitalization > 24 hours. Crude event rate = total events divided by subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.

Incidence of Severe COPD Exacerbations

Severe COPD exacerbation = a COPD-related hospitalization > 24 hours. Crude event rate = total events divided by subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.

Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI) Questionnaires

The BDI and TDI measured or quantitated the severity of breathlessness (shortness of breath) in symptomatic subjects. BDI and TDI data were collected, but not analyzed.

Change From Baseline in Glycosylated Hemoglobin (HbA1c)

Change from baseline: mean of (value of observed HbA1c at treatment duration minus baseline value).

Change From Baseline in Fasting Plasma Glucose

Change from baseline: mean of (value of observed fasting plasma glucose in milligrams/deciliters (mg/dL) at treatment duration minus baseline value).

Change From Baseline in Body Weight

Change from baseline: mean of (value of observed body weight in kilograms (kg) at treatment duration minus baseline value).

Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Unadjusted for Body Weight)

Intermediate-/long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups.

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

Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.

Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Adjusted for Body Weight)

Intermediate/long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups. Dose was adjusted for body weight (units divided by kg).

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

Lipids

Lipids collected: Total cholesterol, high-density lipoprotein, low-density lipoptrotein, and triglycerides. Lipids data were collected, but not analyzed.

Hypoglycemic Event Rates

A hypoglycemic event was identified by characteristic symptoms; blood glucose levels at 59 mg/dL (3.2 mmol/L) or less with a glucose check; or any glucose measurement 49 mg/dL (2.7 mmol/L) or less, with or without symptoms. Crude event rate=total events divided by subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.

Severe Hypoglcyemic Event Rates

An event was severe if the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL or the blood glucose was not measured, but the clinical manifestations were reversed by oral carbohydrates, subcutaneous glucagon, or intravenous glucose. Crude event rate=total events/100 subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.

Full Information

NCT ID

NCT00138671

First Posted

August 26, 2005

Last Updated

January 25, 2010

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00138671

Brief Title

A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With COPD

Official Title

Efficacy and Safety of Inhaled Human Insulin (Exubera) Compared With Subcutaneous Human Insulin in the Therapy of Adult Subjects With Type 1 or Type 2 Diabetes Mellitus and Chronic Obstructive Pulmonary Disease: A One-Year, Multicenter, Randomized, Outpatient, Open-Label, Parallel-Group Comparative Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Terminated

Why Stopped

See termination reason in detailed description.

Study Start Date

January 2003 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics with Chronic Obstructive Pulmonary Disease.

Detailed Description

Pfizer announced in October 2007 that it would stop marketing Exubera. At that time recruitment for study A2171030 was placed on hold. 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 A2171030 was terminated on June 17, 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, Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

105 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Subcutaneous Insulin

Arm Type

Active Comparator

Arm Title

Inhaled Insulin

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Subcutaneous Insulin

Intervention Description

Subcutaneous short-acting insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or neutral protamine hagedorn (NPH) insulin, or a single bedtime dose of insulin glargine.

Intervention Type

Drug

Intervention Name(s)

Inhaled Insulin

Intervention Description

Inhaled insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or NPH insulin, or a single bedtime dose of insulin glargine.

Primary Outcome Measure Information:

Title

Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

Description

FEV1 was measured in liters (L) 30 minutes following the administration of ipratropium. Change from baseline: mean of (value of observed FEV1 (L) at treatment duration minus baseline value).

Time Frame

Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52

Title

Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusion Capacity (DLco)

Description

Time Frame

Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52

Secondary Outcome Measure Information:

Title

Full Pulmonary Function Tests (PFTs) (Spirometry, Pre-Ipratropium and Pre-Insulin PFTs)

Description

Time Frame

Duration of the study

Title

Full PFTs (DLco, Pre-Ipratropium and Pre- Insulin PFTs)

Description

Full PFTs included DLco pre- and 30-minutes post-ipratropium and were completed between the hours of 6 AM and 10 AM with subjects in the fasting state. Full PFT data were collected, but not analyzed.

Time Frame

Duration of the study

Title

Other PFTs (Besides FEV1 and DLco)

Description

Time Frame

Duration of the study

Title

Bronchodilator Responsiveness as Determined by the Change in FEV1

Description

Time Frame

Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52

Title

Insulin Dose Responsiveness for FEV1

Description

Time Frame

Baseline, Week 9, Week 51

Title

Insulin Dose Responsiveness for DLco

Description

Time Frame

Baseline, Week 9, Week 51

Title

Methacholine PC20

Description

Time Frame

Duration of the study

Title

Mean Weekly Number of Puffs of Short-Acting Bronchodilator Used

Description

Time Frame

Duration of the study

Title

Incidence of Non-Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

Description

Time Frame

0 to 1 week to > 9 months

Title

Incidence of Severe COPD Exacerbations

Description

Time Frame

0 to 1 week to > 9 months

Title

Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI) Questionnaires

Description

The BDI and TDI measured or quantitated the severity of breathlessness (shortness of breath) in symptomatic subjects. BDI and TDI data were collected, but not analyzed.

Time Frame

Duration of the study

Title

Change From Baseline in Glycosylated Hemoglobin (HbA1c)

Description

Change from baseline: mean of (value of observed HbA1c at treatment duration minus baseline value).

Time Frame

Baseline, Weeks 6, 12, 26, 39, and 52

Title

Change From Baseline in Fasting Plasma Glucose

Description

Change from baseline: mean of (value of observed fasting plasma glucose in milligrams/deciliters (mg/dL) at treatment duration minus baseline value).

Time Frame

Baseline, Weeks 6, 12, 26, 39, 52

Title

Change From Baseline in Body Weight

Description

Change from baseline: mean of (value of observed body weight in kilograms (kg) at treatment duration minus baseline value).

Time Frame

Baseline, Weeks 1, 2, 3, 4, 6, 9, 11, 12, 18, 26, 39, 50, 51, 52

Title

Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Unadjusted for Body Weight)

Description

Intermediate-/long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups.

Time Frame

Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52

Title

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

Description

Time Frame

Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52

Title

Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Adjusted for Body Weight)

Description

Intermediate/long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups. Dose was adjusted for body weight (units divided by kg).

Time Frame

Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52

Title

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

Description

Time Frame

Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52

Title

Lipids

Description

Lipids collected: Total cholesterol, high-density lipoprotein, low-density lipoptrotein, and triglycerides. Lipids data were collected, but not analyzed.

Time Frame

Duration of the study

Title

Hypoglycemic Event Rates

Description

Time Frame

0 to1 month to > 11 months

Title

Severe Hypoglcyemic Event Rates

Description

Time Frame

0 to 1 month to > 11 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

77 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Glendale

State/Province

Arizona

ZIP/Postal Code

85306

Country

United States

Facility Name

Pfizer Investigational Site

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

Facility Name

Pfizer Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85004

Country

United States

Facility Name

Pfizer Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85006

Country

United States

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

Jonesboro

State/Province

Arkansas

ZIP/Postal Code

72401

Country

United States

Facility Name

Pfizer Investigational Site

City

Searcy

State/Province

Arkansas

ZIP/Postal Code

72143

Country

United States

Facility Name

Pfizer Investigational Site

City

Berkeley

State/Province

California

ZIP/Postal Code

94705

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

Huntington Beach

State/Province

California

ZIP/Postal Code

92648

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

Riverside

State/Province

California

ZIP/Postal Code

92506

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

Denver

State/Province

Colorado

ZIP/Postal Code

80209

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

33756

Country

United States

Facility Name

Pfizer Investigational Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

Pfizer Investigational Site

City

DeLand

State/Province

Florida

ZIP/Postal Code

32720

Country

United States

Facility Name

Pfizer Investigational Site

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32608

Country

United States

Facility Name

Pfizer Investigational Site

City

Lake City

State/Province

Florida

ZIP/Postal Code

32025

Country

United States

Facility Name

Pfizer Investigational Site

City

Melbourne

State/Province

Florida

ZIP/Postal Code

32901

Country

United States

Facility Name

Pfizer Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

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

Winter Park

State/Province

Florida

ZIP/Postal Code

32789

Country

United States

Facility Name

Pfizer Investigational Site

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30033

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

Honululu

State/Province

Hawaii

ZIP/Postal Code

96814

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

Normal

State/Province

Illinois

ZIP/Postal Code

61761

Country

United States

Facility Name

Pfizer Investigational Site

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47713-1227

Country

United States

Facility Name

Pfizer Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46250

Country

United States

Facility Name

Pfizer Investigational Site

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50314

Country

United States

Facility Name

Pfizer Investigational Site

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67203

Country

United States

Facility Name

Pfizer Investigational Site

City

Madisonville

State/Province

Kentucky

ZIP/Postal Code

42431

Country

United States

Facility Name

Pfizer Investigational Site

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70119

Country

United States

Facility Name

Pfizer Investigational Site

City

Springfield

State/Province

Massachusetts

ZIP/Postal Code

01103

Country

United States

Facility Name

Pfizer Investigational Site

City

Springfield

State/Province

Massachusetts

ZIP/Postal Code

01107

Country

United States

Facility Name

Pfizer Investigational Site

City

Waltham

State/Province

Massachusetts

ZIP/Postal Code

02453

Country

United States

Facility Name

Pfizer Investigational Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64106

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

Omaha

State/Province

Nebraska

ZIP/Postal Code

68105

Country

United States

Facility Name

Pfizer Investigational Site

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89015

Country

United States

Facility Name

Pfizer Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89103

Country

United States

Facility Name

Pfizer Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89128

Country

United States

Facility Name

Pfizer Investigational Site

City

Albany

State/Province

New York

ZIP/Postal Code

12205

Country

United States

Facility Name

Pfizer Investigational Site

City

Albany

State/Province

New York

ZIP/Postal Code

12206

Country

United States

Facility Name

Pfizer Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45231

Country

United States

Facility Name

Pfizer Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

Pfizer Investigational Site

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43608

Country

United States

Facility Name

Pfizer Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Pfizer Investigational Site

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Pfizer Investigational Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97219

Country

United States

Facility Name

Pfizer Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15243

Country

United States

Facility Name

Pfizer Investigational Site

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29303

Country

United States

Facility Name

Pfizer Investigational Site

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29307

Country

United States

Facility Name

Pfizer Investigational Site

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

Pfizer Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

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

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Pfizer Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

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

San Antonio

State/Province

Texas

ZIP/Postal Code

78237

Country

United States

Facility Name

Pfizer Investigational Site

City

Fredericksburg

State/Province

Virginia

ZIP/Postal Code

22401

Country

United States

Facility Name

Pfizer Investigational Site

City

Fredericksburg

State/Province

Virginia

ZIP/Postal Code

22408

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

Richmond

State/Province

Virginia

ZIP/Postal Code

23229

Country

United States

Facility Name

Pfizer Investigational Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23235

Country

United States

Facility Name

Pfizer Investigational Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23249

Country

United States

Facility Name

Pfizer Investigational Site

City

Spokane

State/Province

Washington

ZIP/Postal Code

99202

Country

United States

Facility Name

Pfizer Investigational Site

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

Pfizer Investigational Site

City

Huntington

State/Province

West Virginia

ZIP/Postal Code

25701

Country

United States

Facility Name

Pfizer Investigational Site

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53705

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

Campinas

State/Province

ZIP/Postal Code

13083-900

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

São Paulo

State/Province

ZIP/Postal Code

04231-030

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T5J 3N4

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

Burlington

State/Province

Ontario

ZIP/Postal Code

L7M 4Y1

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

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

Pfizer Investigational Site

City

San Jose

Country

Costa Rica

Facility Name

Pfizer Investigational Site

City

Neuss

ZIP/Postal Code

41460

Country

Germany

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2171030&StudyName=A%20One%20Year%20Clinical%20Trial%20Assessing%20the%20Usefulness%20and%20Safety%20of%20Inhaled%20Insulin%20in%20Diabetics%20with%20COPD

Description

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Learn more about this trial

A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With COPD

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A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With COPD

Diabetes Mellitus, Chronic Obstructive Pulmonary Disease

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