Insulin Lispro 6 Day (6D)
DrugAdministered by infusion pump for 12 week treatment period
Other names: Insulin Lispro Formulation, Humalog, LY275585
NCT Number: NCT01134107
Patients will continue to use their current insulin pump for this study. Patients will receive insulin lispro and insulin aspart during this study. One medication will be taken for 12 weeks and then the other medication for 12 weeks. Neither the patient nor the study doctor will know which medication is being taken at any time. The order in which the two medications are taken will be determined by chance.
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Notify Me13 year and older
All sexes
Interventional
Phase 3
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, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered by infusion pump for 12 week treatment period
Other names: Insulin Lispro Formulation, Humalog, LY275585
Administered by infusion pump for 12 week treatment period
Time frame: Day 6 of each reservoir cycle for the last 6 weeks of each 12-week treatment period (Week 7 through Week 12)
Time frame: Days 1-6 and Day 2 and Day 6 for each reservoir cycle throughout each 12-week treatment period
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.
Time frame: Days 1-6 for each reservoir cycle throughout each 12-week treatment period
Time frame: Baseline, endpoint for each 12-week treatment period
Time frame: Endpoint for each 12-week treatment period
Time frame: Baseline, endpoint for each 12-week treatment period
Time frame: Days 1-6 for each reservoir cycle throughout each 12-week treatment period
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
Time frame: Days 1-6 for each reservoir cycle throughout each 12-week treatment period
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.
Time frame: Days 1-6 for each reservoir cycle throughout each 12-week treatment period
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.
Time frame: Days 1-6 for each reservoir cycle throughout each 12-week treatment period
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.
Time frame: All days for each reservoir cycle throughout each 12-week treatment period
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
Time frame: All days for each reservoir cycle throughout each 12-week treatment period
All Reported Hypoglycemic Episodes are defined as an event which is associated with
Time frame: Baseline, endpoint for each 12-week treatment period
Time frame: Baseline, endpoint for each 12-week treatment period
Eli Lilly and Company
Industry
A Double-Blind, Randomized, Crossover Trial of CSII Reservoir In-use Comparing Insulin Lispro Formulation to Insulin Aspart in Patients With Type 1 Diabetes Mellitus
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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