| Outcome Measures: |
Primary: Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at End of Treatment, Change from Baseline in glycosylated hemoglobin A1c (HbA1c %) at Week 24. Change = mean value at Week 24 minus mean value at Baseline., Baseline, Week 24 (End of Treatment) | Secondary: Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit, Change in mean glycosylated hemoglobin A1c (HbA1c %) from Baseline to each visit through Week 24. Change = mean value at observation minus mean value at Baseline., Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) < 7.0%, < 6.5% and < 6.0% at Week 24, Number of subjects acheiving glycemic control: HbA1c target levels of \<7.0%, \<6.5%, and \<6.0% at Week 24., Week 24|Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) Target Levels of <7%, < 6.5%, and < 6.0% Without an Episode of Severe Hypoglycemia at Week 24, Number of subjects that attained HbA1c target levels of \<7%, \< 6.5%,and \<6.0% at Week 24 without an episode of severe hypoglycemia., Week 24|Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles, Mean change from Baseline in fasting and 2-hour postprandial glucose at each visit in 8-point self-monitored blood glucose (SMBG) profiles: includes values prior to each meal (breakfast, lunch and dinner), 2 hours after each meal, at bedtime, and at 2:00 ante meridiem (a.m.) Change=observation value minus Baseline value., Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 12, Change from Baseine in fasting and postprandial plasma glucose as determined by standardized meal tolerance tests (MTT). Change = mean value at Week 12 minus mean value at Baseline. Time 0 results are for MTT (time 0) and non MTT (implied time 0) subjects., Baseline, Week 12|Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 24, Change from Baseline in fasting and postprandial plasma glucose as determined by standardized meal tolerance tests (MTT). Change = mean value at Week 24 minus mean value at Baseline. Time 0 results are for MTT (time 0) and non MTT (implied time 0) subjects., Baseline, Week 24|Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests, Change from Baseline in fasting and postprandial lipids at Week 12 and Week 24 as determined by standard meal tolerance tests. Change = value at observation minus value at Baseline. Postprandial = 120 mins after meal., Baseline, Week 12, Week 24|Number of Subjects With Change From Baseline in Fasting and Postprandial Markers of Cardiovascular (CV) Risk as Determined by Standardized Meal Tolerance Tests, Cardiovascular risk markers included serum high-sensitivity C-reactive protein (hs-CRP)\[mg/L\], leptin (ng/mL), adiponectin (ug/mL), and spot urine microalbumin. Change = observation of mean fasting and postprandial markers of cardiovascular risk at Week 12 and Week 24 minus mean Baseline observation., Week 12, Week 24|Change From Baseline Weight at Each Visit, Change = mean body weight at observation minus mean body weight at Baseline., Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|Change From Baseline in Fasting Plasma Lipids, Change from baseline in fasting plasma lipids at Week 12 and Week 24. Change = observation mean minus Baseline mean., Baseline, Week 12, Week 24|Change From Baseline in Insulin Glargine Dose at Each Visit (Office and/or Phone), Change from Baseline in insulin glargine at each visit. Change = mean at observation minus mean Baseline observation. Basal dose = injection of basal insulin (IU) (insulin glargine)., Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|Baseline Prandial Insulin Dose (at Each Meal) at Each Visit, Dose of inhaled insulin prior to each meal at each visit., Week 0, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|Number of Subjects With Hypoglycemic Events, Severe event = subject unable to treat self, at least 1 neurological symptom (memory loss, confusion, uncontrollable/irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose \<= 49 milligrams per deciliter (mg/dL) or not measured but clinical manifestations reversed by oral carbohydrates or glucose. Non-severe events = events that were mild-moderate., Month 1, Month 2, Month 3, Month 4, Month 5, Month 6|Number of Total Hypoglycemic Events, Total number and severity of hypoglycemic events. Severe events = subject unable to treat self, at least 1 neurological symptom (memory loss, confusion, uncontrollable or irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose \<= 49 milligrams per deciliter (mg/dL) or not measured but clinical manifestations reversed by oral carbohydrates or glucose. Non-severe events = events that were mild or moderate., Month 1, Month 2, Month 3, Month 4, Month 5, Month 6|Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment, Subject months of treatment = number of days from start of treatment to last day of active treatment + 1 day lag (total number of subjects treated \* days treated), including off-drug time)/30.44. Severity: severe = subject unable to treat self, had at least 1 neurological symptom (memory loss, confusion, uncontrollable/irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose \<= 49 milligrams/deciliter; or not measured but clinical manifestations were reversed by oral carbohydrates or glucose. Non-severe events = events that were mild or moderate., Month 1, Month 2, Month 3, Month 4, Month 5, Month 6|Crude Hypoglycemic Event Rate, Crude event rate = (number of events)/(subject months); severe hypoglycemic events: crude event rate = (number of events)/(100 subject months). Severe = subject unable to treat self, at least 1 neurological symptom (memory loss, confusion, uncontrollable or irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose \<= 49 milligrams per deciliter (mg/dL) or unmeasured but clinical manifestestation reversed by oral carbohydrates or glucose. Non-severe events = mild-moderate., Month 1, Month 2, Month 3, Month 4, Month 5, Month 6|Change From Baseline in Patient Treatment Satisfaction (as Assessed by Patient Satisfaction With Insulin Treatment [PSIT] Questionnaire), Patient Satisfaction with insulin treatment Questionnaire (PSIT): 15-item self administered questionnaire that measures global satisfaction and two domains (subscales): convenience/ease of use and social comfort in people with type 1 and type 2 diabetes. 5-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). The scoring of responses to each item is analyzed so that a higher item score indicates more satisfaction. Change = mean Patient Satisfaction of Insulin Treatment (PSIT) score at observation minus mean score at Baseline., Week 4, Week 24|Change in Patient Treatment Satisfaction (as Assessed by Patient Satisfaction With Insulin Treatment [PSIT] Questionnaire) From Week 4 to Week 24, Patient Satisfaction with insulin treatment Questionnaire (PSIT): 15-item self administered questionnaire that measures global satisfaction and two domains (subscales): convenience/ease of use and social comfort in people with type 1 and type 2 diabetes. 5-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). The scoring of responses to each item is analyzed so that a higher item score indicates more satisfaction. Change = difference in mean Patient Satisfaction with Insulin Treatment (PSIT) score from Week 4 to Week 24., Week 4, Week 24|Change From Baseline in 24-hour Mean Glucose Values Measured by Continuous Glucose Monitoring System (CGMS), Mean of 24-hour Continuous Glucose Monitoring (CGMS) glucose values. Change from Baseline = mean at observation minus mean Baseline value., Baseline, Week 12, Week 24|Change From Baseline in Standard Deviation of 24-hour Glucose Values Measured by Continuous Glucose Monitoring System (CGMS), Mean change in standard deviation of all blood glucose values within 24-hour period. Change = mean at observation minus mean at Baseline., Baseline, Week 12, Week 24
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| Locations: |
Pfizer Investigational Site, Birmingham, Alabama, 35294-307, United States|Pfizer Investigational Site, Mobile, Alabama, 36608, United States|Pfizer Investigational Site, Phoenix, Arizona, 85006-2850, United States|Pfizer Investigational Site, Malvern, Arkansas, 72104, United States|Pfizer Investigational Site, Foot Hill Ranch, California, 92610, United States|Pfizer Investigational Site, Fresno, California, 93720, United States|Pfizer Investigational Site, Greenbrae, California, 94904, United States|Pfizer Investigational Site, Los Gatos, California, 95032-3739, United States|Pfizer Investigational Site, San Diego, California, 92120, United States|Pfizer Investigational Site, San Mateo, California, 94401-3805, United States|Pfizer Investigational Site, Tustin, California, 92780, United States|Pfizer Investigational Site, Denver, Colorado, 80209, United States|Pfizer Investigational Site, New Britain, Connecticut, 06050, United States|Pfizer Investigational Site, Washington, District of Columbia, 20010-2934, United States|Pfizer Investigational Site, Jacksonville, Florida, 32205, United States|Pfizer Investigational Site, Jacksonville, Florida, 32216, United States|Pfizer Investigational Site, Miami, Florida, 33156, United States|Pfizer Investigational Site, West Palm Beach, Florida, 33401, United States|Pfizer Investigational Site, Winter Park, Florida, 32789, United States|Pfizer Investigational Site, Columbus, Georgia, 31904, United States|Pfizer Investigational Site, Decatur, Georgia, 30034-1680, United States|Pfizer Investigational Site, Honolulu, Hawaii, 96813, United States|Pfizer Investigational Site, Honululu, Hawaii, 96814, United States|Pfizer Investigational Site, Idaho Falls, Idaho, 83404, United States|Pfizer Investigational Site, Chicago, Illinois, 60607, United States|Pfizer Investigational Site, Gurnee, Illinois, 60031, United States|Pfizer Investigational Site, Des Moines, Iowa, 50314, United States|Pfizer Investigational Site, Lexington, Kentucky, 40503, United States|Pfizer Investigational Site, Louisville, Kentucky, 40213, United States|Pfizer Investigational Site, Baltimore, Maryland, 21234-4607, United States|Pfizer Investigational Site, Bethesda, Maryland, 20817, United States|Pfizer Investigational Site, Boston, Massachusetts, 02114, United States|Pfizer Investigational Site, Flint, Michigan, 48532, United States|Pfizer Investigational Site, Minneapolis, Minnesota, 55454-1321, United States|Pfizer Investigational Site, St. Louis, Missouri, 63110, United States|Pfizer Investigational Site, St. Louis, Missouri, 63141, United States|Pfizer Investigational Site, Omaha, Nebraska, 68131, United States|Pfizer Investigational Site, East Syracuse, New York, 13057, United States|Pfizer Investigational Site, Greenville, North Carolina, 27834, United States|Pfizer Investigational Site, Morehead City, North Carolina, 28557, United States|Pfizer Investigational Site, Statesville, North Carolina, 28625, United States|Pfizer Investigational Site, Kettering, Ohio, 45429, United States|Pfizer Investigational Site, Oklahoma City, Oklahoma, 73103, United States|Pfizer Investigational Site, Tulsa, Oklahoma, 74104, United States|Pfizer Investigational Site, Bend, Oregon, 97701, United States|Pfizer Investigational Site, Bensalem, Pennsylvania, 19020, United States|Pfizer Investigational Site, Greenville, South Carolina, 29615, United States|Pfizer Investigational Site, Bartlett, Tennessee, 38133, United States|Pfizer Investigational Site, Memphis, Tennessee, 38119, United States|Pfizer Investigational Site, Arlington, Texas, 76012, United States|Pfizer Investigational Site, Arlington, Texas, 76014, United States|Pfizer Investigational Site, Dallas, Texas, 75230, United States|Pfizer Investigational Site, Dallas, Texas, 75246, United States|Pfizer Investigational Site, El Paso, Texas, 79935, United States|Pfizer Investigational Site, Houston, Texas, 77004, United States|Pfizer Investigational Site, San Antonio, Texas, 78229, United States|Pfizer Investigational Site, Bennington, Vermont, 05201-5018, United States|Pfizer Investigational Site, Norfolk, Virginia, 23502, United States|Pfizer Investigational Site, Virginia Beach, Virginia, 23462, United States|Pfizer Investigational Site, Renton, Washington, 98055, United States|Pfizer Investigational Site, Spokane, Washington, 99208, United States|Pfizer Investigational Site, Milwaukee, Wisconsin, 53209, United States|Pfizer Investigational Site, San Juan, 00936-5067, Puerto Rico
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