| Outcome Measures: |
Primary: Mean of Last Six 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Insulin Aspart 6D Pump Reservoir In-use, Day 6 of each reservoir cycle for the last 6 weeks of each 12-week treatment period (Week 7 through Week 12) | Secondary: Mean SMBG, Mean SMBG for combined periods; all reported SMBG values on Days 1-6, Day 2, and Day 6 for Insulin Lispro 6D and Insulin Aspart 6D., Days 1-6 and Day 2 and Day 6 for each reservoir cycle throughout each 12-week treatment period|Mean Daily Insulin Dose (Total, Basal, and Bolus), Days 1-6 for each reservoir cycle throughout each 12-week treatment period|Change From Baseline to 12 Weeks for Each Treatment in Glycated Hemoglobin A1c (HbA1c) Values, Baseline, endpoint for each 12-week treatment period|Number of Participants Who Achieve or Maintain a Glycated Hemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than 7%, Endpoint for each 12-week treatment period | Other: Change From Baseline to 12 Weeks for Daily Insulin Dose (Total, Basal, and Bolus), Baseline, endpoint for each 12-week treatment period|Percentage of Participants Having a Hyperglycemic Episode, A hyperglycemic episode was defined as an event with (1) a measured blood glucose concentration \>250 milligrams per deciliter (mg/dL) (13.9 millimoles per liter \[mmol/L\]) and ≥3 hours after eating, or (2) a measured blood glucose concentration \>300 mg/dL (16.7 mmol/L) and \<3 hours after eating, Days 1-6 for each reservoir cycle throughout each 12-week treatment period|Hyperglycemic Episode Rate Per 30 Days, Hyperglycemia was defined as an episode with (1) a measured blood glucose concentration \>250 milligrams per deciliter \[mg/dL\] (13.9 millimoles per liter \[mmol/L\]) and ≥3 hours after eating, or (2) a measured blood glucose concentration \>300 mg/dL (16.7 mmol/L) and \<3 hours after eating. Rate is presented as the number of hyperglycemic episodes adjusted for 30 days., Days 1-6 for each reservoir cycle throughout each 12-week treatment period|Percentage of Participants With Pump Complications, Overall pump complications are defined as any combination of the following, reported by the participant: tubing clogged, tubing kinked, tubing disconnect, tubing pulled out, blood in tubing, too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm, skin abscess at site, excessive redness at site, swelling (not nodule) at site, bleeding at site, bruising at site, reservoir change (infusion set change reason only), and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether the change occurred early (prior to 6 days). If he/she responded 'yes', then the reported change was recorded as a premature change., Days 1-6 for each reservoir cycle throughout each 12-week treatment period|Pump Complications Rate Per 30 Days, Overall pump complications are defined as any combination of the following reported by the participant: tubing clogged, tubing kinked, tubing disconnect, tubing pulled out, blood in tubing, too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm, skin abscess at site, excessive redness at site, swelling (not nodule) at site, bleeding at site, bruising at site, reservoir change (infusion set change reason only), and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether the change occurred early (prior to 6 days). If he/she responded 'yes', then the reported change was recorded as a premature change., Days 1-6 for each reservoir cycle throughout each 12-week treatment period|Percentage of Participants Having a Hypoglycemic Episode, A Documented Hypoglycemic Episode is defined as an event which is associated with a documented blood glucose (BG) concentration of \<= 70 mg/dL (3.9 mmol/L). All Reported Hypoglycemic Episodes are defined as an event which is associated with 1. reported signs and symptoms of hypoglycemia, and/or 2. a documented blood glucose (BG) concentration of \<= 70 mg/dL (3.9 mmol/L), All days for each reservoir cycle throughout each 12-week treatment period|Hypoglycemic Episode Rate Per 30 Days, All Reported Hypoglycemic Episodes are defined as an event which is associated with 1. reported signs and symptoms of hypoglycemia, and/or 2. a documented blood glucose (BG) concentration of \<= 70 mg/dL (3.9 mmol/L), All days for each reservoir cycle throughout each 12-week treatment period|Change From Baseline to 12 Week Endpoint for Each Treatment in Weight, Baseline, endpoint for each 12-week treatment period|Change From Baseline to 12 Weeks Endpoint for Each Treatment in Blood Pressure, Baseline, endpoint for each 12-week treatment period
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| Locations: |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Caen, 14033, France|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Corbeil-Essonnes, 91106, France|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., La Rochelle, 17019, France|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Marseille, 13009, France|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Montpellier, 34295, France|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Narbonne, 11108, France|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Ludwigshafen, 67059, Germany|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Mainz, 55116, Germany|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Münster, 48145, Germany|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Neuwied, 56564, Germany|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Potsdam, 14469, Germany|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Bekescsaba, 5600, Hungary|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Budapest, 1023, Hungary|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Nyiregyhaza, 4400, Hungary|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Zalaegerszeg, 8900, Hungary
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