| Outcome Measures: |
Primary: 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)., Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52|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)., Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52 | Secondary: 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., Duration of the study|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., Duration of the study|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., Duration of the study|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., Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52|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)., Baseline, Week 9, Week 51|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)., Baseline, Week 9, Week 51|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., Duration of the study|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., Duration of the study|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., 0 to 1 week to > 9 months|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., 0 to 1 week to > 9 months|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., Duration of the study|Change From Baseline in Glycosylated Hemoglobin (HbA1c), Change from baseline: mean of (value of observed HbA1c at treatment duration minus baseline value)., Baseline, Weeks 6, 12, 26, 39, and 52|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)., Baseline, Weeks 6, 12, 26, 39, 52|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)., Baseline, Weeks 1, 2, 3, 4, 6, 9, 11, 12, 18, 26, 39, 50, 51, 52|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., Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52|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., Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52|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)., Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52|Mean Total Daily Short-Acting Insulin Dose (Adjusted 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. Dose was adjusted for body weight (mg divided by kg or units divided by kg)., Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52|Lipids, Lipids collected: Total cholesterol, high-density lipoprotein, low-density lipoptrotein, and triglycerides. Lipids data were collected, but not analyzed., Duration of the study|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., 0 to1 month to > 11 months|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., 0 to 1 month to > 11 months
|
| Locations: |
Pfizer Investigational Site, Glendale, Arizona, 85306, United States|Pfizer Investigational Site, Peoria, Arizona, 85381, United States|Pfizer Investigational Site, Phoenix, Arizona, 85004, United States|Pfizer Investigational Site, Phoenix, Arizona, 85006, United States|Pfizer Investigational Site, Phoenix, Arizona, 85016, United States|Pfizer Investigational Site, Tucson, Arizona, 85715, United States|Pfizer Investigational Site, Jonesboro, Arkansas, 72401, United States|Pfizer Investigational Site, Searcy, Arkansas, 72143, United States|Pfizer Investigational Site, Berkeley, California, 94705, United States|Pfizer Investigational Site, Fresno, California, 93720, United States|Pfizer Investigational Site, Greenbrae, California, 94904, United States|Pfizer Investigational Site, Huntington Beach, California, 92648, United States|Pfizer Investigational Site, Los Angeles, California, 90073, United States|Pfizer Investigational Site, Riverside, California, 92506, United States|Pfizer Investigational Site, Tustin, California, 92780, United States|Pfizer Investigational Site, Denver, Colorado, 80209, United States|Pfizer Investigational Site, Waterbury, Connecticut, 06708, United States|Pfizer Investigational Site, Chiefland, Florida, 32626, United States|Pfizer Investigational Site, Clearwater, Florida, 33756, United States|Pfizer Investigational Site, Clearwater, Florida, 33765, United States|Pfizer Investigational Site, DeLand, Florida, 32720, United States|Pfizer Investigational Site, Gainesville, Florida, 32608, United States|Pfizer Investigational Site, Lake City, Florida, 32025, United States|Pfizer Investigational Site, Melbourne, Florida, 32901, United States|Pfizer Investigational Site, Miami, Florida, 33144, United States|Pfizer Investigational Site, West Palm Beach, Florida, 33401, United States|Pfizer Investigational Site, Winter Park, Florida, 32789, United States|Pfizer Investigational Site, Decatur, Georgia, 30033, United States|Pfizer Investigational Site, Honolulu, Hawaii, 96813, United States|Pfizer Investigational Site, Honululu, Hawaii, 96814, United States|Pfizer Investigational Site, Chicago, Illinois, 60607, United States|Pfizer Investigational Site, Normal, Illinois, 61761, United States|Pfizer Investigational Site, Evansville, Indiana, 47713-1227, United States|Pfizer Investigational Site, Indianapolis, Indiana, 46250, United States|Pfizer Investigational Site, Des Moines, Iowa, 50314, United States|Pfizer Investigational Site, Wichita, Kansas, 67203, United States|Pfizer Investigational Site, Madisonville, Kentucky, 42431, United States|Pfizer Investigational Site, New Orleans, Louisiana, 70119, United States|Pfizer Investigational Site, Springfield, Massachusetts, 01103, United States|Pfizer Investigational Site, Springfield, Massachusetts, 01107, United States|Pfizer Investigational Site, Waltham, Massachusetts, 02453, United States|Pfizer Investigational Site, Kansas City, Missouri, 64106, United States|Pfizer Investigational Site, St. Louis, Missouri, 63141, United States|Pfizer Investigational Site, Butte, Montana, 59701, United States|Pfizer Investigational Site, Omaha, Nebraska, 68105, United States|Pfizer Investigational Site, Henderson, Nevada, 89015, United States|Pfizer Investigational Site, Las Vegas, Nevada, 89103, United States|Pfizer Investigational Site, Las Vegas, Nevada, 89128, United States|Pfizer Investigational Site, Albany, New York, 12205, United States|Pfizer Investigational Site, Albany, New York, 12206, United States|Pfizer Investigational Site, Cincinnati, Ohio, 45231, United States|Pfizer Investigational Site, Cincinnati, Ohio, 45242, United States|Pfizer Investigational Site, Toledo, Ohio, 43608, United States|Pfizer Investigational Site, Oklahoma City, Oklahoma, 73103, United States|Pfizer Investigational Site, Medford, Oregon, 97504, United States|Pfizer Investigational Site, Portland, Oregon, 97219, United States|Pfizer Investigational Site, Pittsburgh, Pennsylvania, 15243, United States|Pfizer Investigational Site, Spartanburg, South Carolina, 29303, United States|Pfizer Investigational Site, Spartanburg, South Carolina, 29307, United States|Pfizer Investigational Site, Memphis, Tennessee, 38119, United States|Pfizer Investigational Site, Nashville, Tennessee, 37203, United States|Pfizer Investigational Site, Beaumont, Texas, 77701, United States|Pfizer Investigational Site, Beaumont, Texas, 77706, United States|Pfizer Investigational Site, Dallas, Texas, 75231, United States|Pfizer Investigational Site, Houston, Texas, 77030, United States|Pfizer Investigational Site, San Antonio, Texas, 78229, United States|Pfizer Investigational Site, San Antonio, Texas, 78237, United States|Pfizer Investigational Site, Fredericksburg, Virginia, 22401, United States|Pfizer Investigational Site, Fredericksburg, Virginia, 22408, United States|Pfizer Investigational Site, Richmond, Virginia, 23225, United States|Pfizer Investigational Site, Richmond, Virginia, 23229, United States|Pfizer Investigational Site, Richmond, Virginia, 23235, United States|Pfizer Investigational Site, Richmond, Virginia, 23249, United States|Pfizer Investigational Site, Spokane, Washington, 99202, United States|Pfizer Investigational Site, Spokane, Washington, 99204, United States|Pfizer Investigational Site, Huntington, West Virginia, 25701, United States|Pfizer Investigational Site, Madison, Wisconsin, 53705, United States|Pfizer Investigational Site, Porto Alegre, RS, 90035-170, Brazil|Pfizer Investigational Site, Campinas, SP, 13083-900, Brazil|Pfizer Investigational Site, Sao Paulo, SP, 01244-030, Brazil|Pfizer Investigational Site, São Paulo, SP, 04231-030, Brazil|Pfizer Investigational Site, Edmonton, Alberta, T5J 3N4, Canada|Pfizer Investigational Site, Red Deer, Alberta, T4N 6V7, Canada|Pfizer Investigational Site, Burlington, Ontario, L7M 4Y1, Canada|Pfizer Investigational Site, Laval, Quebec, H7T 2P5, Canada|Pfizer Investigational Site, Sherbrooke, Quebec, J1H 5N4, Canada|Pfizer Investigational Site, San Jose, Costa Rica|Pfizer Investigational Site, Neuss, 41460, Germany
|
