| Outcome Measures: |
Primary: Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population, HbA1c lab value: Change = value at Week 26 minus value at Baseline., Baseline, Week 26 | Secondary: Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26, Percentage of subjects with glycosylated hemoglobin A1c lab value less than 6.5%., Week 26|Percentage of Subjects Achieving Glycemic Control (HbA1c < 7.0%) at Week 26, Percentage of subjects with glycosylated hemoglobin A1c lab value less than 7.0%., Week 26|Percentage of Subjects Achieving Glycemic Control (HbA1c < 8.0%) at Week 26, Number of subjects with glycosylated hemoglobin A1c lab value less than 8.0%., Week 26|Change From Baseline in Fasting Plasma Glucose at Week 26, Fasting plasma glucose lab value: Change = value at Week 26 minus value at Baseline., Baseline, Week 26|Change From Baseline in Fasting and Postprandial Blood Glucose as Determined by Standardized Meal Tolerance Tests at Week 26, Postprandial blood glucose lab value (Time 0 min \[fasting\], Time 30 min, Time 60 min, Time 90 min, Time 120 min, Time 180 min): Change = value at Week 26 minus value at Baseline., Baseline, Week 26|Change From Baseline in Postprandial Blood Glucose as Measured by 8-Point Profiles at Week 26, Post-prandial=after a meal. 8-point scale: (1 = before breakfast, 2 = 2 hours post breakfast, 3 = before lunch, 4 = 2 hours post lunch, 5 = before dinner, 6 = 2 hours post dinner, 7 = at bedtime, 8 = overnight \[between 2 and 4 am\]). Postprandial blood glucose lab value: Change = value at Week 26 minus value at Baseline., Baseline, Week 26|Change From Baseline in Lipids at Week 26, Lipid (total cholesterol, high density lipoprotein cholesterol \[HDL-c\], low density lipoprotein cholesterol \[LDL-c\], triglycerides) lab value: Change = value at Week 26 minus value at Baseline., Baseline, Week 26|Change From Baseline in Cardiovascular (CV) Biomarkers High Sensitivity C-reactive Protein (Hs-CRP), Leptin, and Spot Urine Microalbumin at Week 26, CV biomarker (hs-CRP, Leptin, and Spot Urine Microalbumin) lab value: Change = value at Week 26 minus value at Baseline., Baseline, Week 26|Change From Baseline in CV Biomarkers Adiponectin and Apolipoprotein B (ApoB) at Week 26, CV biomarker (adiponectin and ApoB) lab value: Change = value at Week 26 minus value at Baseline., Baseline, Week 26|Change From Baseline in 24-Hour Continuous Glucose Monitoring System (CGMS) Glucose Values at Week 26, 24-Hour CGMS glucose lab value was obtained using the Medtronic MiniMed CGMS. Not all subjects were offered the opportunity to participate in this assessment. Change = value at Week 26 minus value at Baseline., Baseline, Week 26|Change From Baseline in Mean Standard Deviation (SD) of 24-Hour Glucose Values Measured by CGMS at Week 26, SD of 24-Hour CGMS glucose lab value obtained using the Medtronic MiniMed CGMS. Not all subjects were offered the opportunity to participate in this assessment. Change = value at Week 26 minus value at Baseline., Baseline, Week 26|Number of Subjects With Hypoglycemic Events, A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. 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. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe., Months 1 to 7|Number of Total Hypoglycemic Events, A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of \< = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe. Total=events during the study., Months 1 to 7|Number of Total Subject Months of Treatment, Number of total subject months of treatment. Subject months = number of days from start of treatment to the last day of active treatment + 1 day lag, including off-drug time)/30.44. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of \< = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe., Months 1 to 7|Crude Hypoglycemic Event Rate, crude event rate=(events)/(subject-months). Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of \< = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe., Months 1 to 7|Number of Nocturnal Hypoglycemic Events, A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of \< = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Nocturnal hypoglycemia=event occuring from midnight to 5:59 am., Months 1 to 7|Change From Baseline in Body Weight at Week 26, Body weight value: Change = value at Week 26 minus value at Baseline., Baseline, Week 26|Change From Baseline in Body Mass Index (BMI) at Week 26, BMI value (kg/m2): Change = value at Week 26 minus value at Baseline., Baseline, Week 26|Change From Baseline in Diabetes Treatment Satisfaction Questionnaire-Status, Diabetes Treatment Satisfaction Questionnaire-Change, Diabetes-39, Mental Health Inventory-17, and SF-36 Vitality Domain Questionnaire, Due to cancellation of the EXUBERA program, the collected Patient Reported Outcome (PRO) data, including the Diabetes Treatment Satisfaction Questionnaire-Status, Diabetes Treatment Satisfaction Questionnaire-Change, Diabetes-39, Mental Health Inventory-17, and SF-36 vitality domain questionnaire were not summarized, and no statistical analyses were performed., Baseline, Week 26 | Other: Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the FAS, HbA1c lab value: Change = value at Week 26 minus value at Baseline., Baseline, Week 26
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| Locations: |
Pfizer Investigational Site, Phoenix, Arizona, 85051, United States|Pfizer Investigational Site, Tucson, Arizona, 85712, United States|Pfizer Investigational Site, Concord, California, 94520, United States|Pfizer Investigational Site, Encino, California, 91436, United States|Pfizer Investigational Site, Fresno, California, 93720, United States|Pfizer Investigational Site, Fullerton, California, 92835, United States|Pfizer Investigational Site, Long Beach, California, 90806, United States|Pfizer Investigational Site, Mission Viejo, California, 92691, United States|Pfizer Investigational Site, Pasadena, California, 91105, United States|Pfizer Investigational Site, San Diego, California, 92120, United States|Pfizer Investigational Site, San Diego, California, 92128, United States|Pfizer Investigational Site, San Luis Obispo, California, 93401, United States|Pfizer Investigational Site, Spring Valley, California, 91978, United States|Pfizer Investigational Site, Stockton, California, 95204, United States|Pfizer Investigational Site, Walnut Creek, California, 94598, United States|Pfizer Investigational Site, West Hills, California, 91307, United States|Pfizer Investigational Site, Golden, Colorado, 80401, United States|Pfizer Investigational Site, Waterbury, Connecticut, 06708, United States|Pfizer Investigational Site, Newark, Delaware, 19713, United States|Pfizer Investigational Site, Chiefland, Florida, 32626, United States|Pfizer Investigational Site, Clearwater, Florida, 33765, United States|Pfizer Investigational Site, Hollywood, Florida, 33023, United States|Pfizer Investigational Site, Kissimmee, Florida, 34741, United States|Pfizer Investigational Site, Miami, Florida, 33156, United States|Pfizer Investigational Site, Ocala, Florida, 34471, United States|Pfizer Investigational Site, Saint Cloud, Florida, 34769, United States|Pfizer Investigational Site, Winter Park, Florida, 32789, United States|Pfizer Investigational Site, Atlanta, Georgia, 30322, United States|Pfizer Investigational Site, Lawrenceville, Georgia, 30045-3388, United States|Pfizer Investigational Site, Lawrenceville, Georgia, 30045, United States|Pfizer Investigational Site, Woodstock, Georgia, 30189, United States|Pfizer Investigational Site, Boise, Idaho, 83702, United States|Pfizer Investigational Site, Hayden Lake, Idaho, 83835, United States|Pfizer Investigational Site, Indianapolis, Indiana, 46254, United States|Pfizer Investigational Site, Overland Park, Kansas, 66211, United States|Pfizer Investigational Site, Topeka, Kansas, 66606, United States|Pfizer Investigational Site, Lexington, Kentucky, 40503, United States|Pfizer Investigational Site, Louisville, Kentucky, 40213, United States|Pfizer Investigational Site, Baton Rouge, Louisiana, 70808, United States|Pfizer Investigational Site, New Orleans, Louisiana, 70121, United States|Pfizer Investigational Site, Haverhill, Massachusetts, 01830-6141, United States|Pfizer Investigational Site, Springfield, Missouri, 65807, United States|Pfizer Investigational Site, Omaha, Nebraska, 68131, United States|Pfizer Investigational Site, Las Vegas, Nevada, 89104, United States|Pfizer Investigational Site, Staten Island, New York, 10301, United States|Pfizer Investigational Site, Charlotte, North Carolina, 28209-3734, United States|Pfizer Investigational Site, Statesville, North Carolina, 28625, United States|Pfizer Investigational Site, Winston-Salem, North Carolina, 27103, United States|Pfizer Investigational Site, Kettering, Ohio, 45429, United States|Pfizer Investigational Site, Maumee, Ohio, 43537-9402, United States|Pfizer Investigational Site, Toledo, Ohio, 43606, United States|Pfizer Investigational Site, Oklahoma City, Oklahoma, 73103, United States|Pfizer Investigational Site, Medford, Oregon, 97504, United States|Pfizer Investigational Site, Melrose Park, Pennsylvania, 19027, United States|Pfizer Investigational Site, Greenville, South Carolina, 29615, United States|Pfizer Investigational Site, Greer, South Carolina, 29651, United States|Pfizer Investigational Site, Spartanburg, South Carolina, 29303, United States|Pfizer Investigational Site, Milan, Tennessee, 38358, United States|Pfizer Investigational Site, Arlington, Texas, 76014-2010, United States|Pfizer Investigational Site, Beaumont, Texas, 77701, United States|Pfizer Investigational Site, Dallas, Texas, 75230, United States|Pfizer Investigational Site, Dallas, Texas, 75231, United States|Pfizer Investigational Site, Dallas, Texas, 75246, United States|Pfizer Investigational Site, El Paso, Texas, 79935, United States|Pfizer Investigational Site, Houston, Texas, 77008, United States|Pfizer Investigational Site, Houston, Texas, 77083, United States|Pfizer Investigational Site, San Antonio, Texas, 78229-3900, United States|Pfizer Investigational Site, San Antonio, Texas, 78229, United States|Pfizer Investigational Site, Bennington, Vermont, 05201-5018, United States|Pfizer Investigational Site, Richmond, Virginia, 23249, United States|Pfizer Investigational Site, Federal Way, Washington, 98003, United States|Pfizer Investigational Site, Menomonee Falls, Wisconsin, 53051, United States|Pfizer Investigational Site, Carolina, 00983, Puerto Rico
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