Clinical trial NCT01134107: Insulin Lispro 6 Days Versus Insulin Aspart 6 Days in Pump Use
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2010-05-31
Enrollment: 133
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 1 diabetes (World Health Organization criteria) for at least 24 months
* Treated with continuous subcutaneous insulin infusion (CSII) therapy for the previous 6 months
* Mean total daily insulin dose for 3 days prior to screening less than or equal to 46 units/day if using a 300-Unit reservoir, less than or equal to 30 units/day if using a 200 unit reservoir, or less than or equal to 26 units/day if using a 180 unit reservoir
* Baseline body mass index (BMI) less than or equal to 35.0 kilograms per meter squared (kg/m2)
* Baseline glycated hemoglobin A1c (HbA1c) 5% to 9%

Exclusion Criteria:

* Impaired renal function (serum creatinine greater than or equal to 2.0 milligrams per deciliter (mg/dL))
* Legal blindness
* Have had any episode in the 12 months prior to screening of hypoglycemic coma, seizures, or disorientation
* Have had hypoglycemia unawareness (routinely asymptomatic at blood glucose less than 45 mg/dL \[2.5 millimoles per liter (mmol/L)\]) in the 12 months prior to screening.
* Have had any emergency room visits or hospitalizations due to poor glucose control in the 12 months prior to screening.
* Have had a pump-related infusion site abscess in the 12 months prior to screening.
* Have had multiple, clinically significant occlusions as judged by the investigator.
* Have had any infection with Staphylococcus aureus in the past 5 years
* Have one of the following concomitant diseases: presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, or any other serious disease considered by the investigator to be exclusionary.
* Participants with malignancy other than basal cell or squamous cell skin cancer who have not yet been treated, are currently being treated, or who were diagnosed less than 5 years ago.
* Have had a blood transfusion or severe blood loss within the 3 months prior to screening or have known hemoglobinopathy, hemolytic or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with HbA1c methodology.
* Are receiving chronic systemic glucocorticoid therapy, or have received such therapy within the 4 weeks preceding screening.
* Have an irregular sleep/wake cycle in the investigator's opinion.
* Have a known hypersensitivity or allergy to any of the study insulins or their excipients
* Are breastfeeding or pregnant, or intend to become pregnant during the course of the study, or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.
* Are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving off-label use of an investigational drug or device, or currently enrolled in any other type of medical research not to be scientifically or medically compatible with this study.
* Are unwilling or unable to comply with the use of a data collection device to directly record data from the participant.

Primary outcomes:
measure: 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
timeFrame: Day 6 of each reservoir cycle for the last 6 weeks of each 12-week treatment period (Week 7 through Week 12)
Secondary outcomes:
measure: Mean SMBG
timeFrame: Days 1-6 and Day 2 and Day 6 for each reservoir cycle throughout each 12-week treatment period
measure: Mean Daily Insulin Dose (Total, Basal, and Bolus)
timeFrame: Days 1-6 for each reservoir cycle throughout each 12-week treatment period
measure: Change From Baseline to 12 Weeks for Each Treatment in Glycated Hemoglobin A1c (HbA1c) Values
timeFrame: Baseline, endpoint for each 12-week treatment period
measure: Number of Participants Who Achieve or Maintain a Glycated Hemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than 7%
timeFrame: Endpoint for each 12-week treatment period
Other outcomes:
measure: Change From Baseline to 12 Weeks for Daily Insulin Dose (Total, Basal, and Bolus)
timeFrame: Baseline, endpoint for each 12-week treatment period
measure: Percentage of Participants Having a Hyperglycemic Episode
timeFrame: Days 1-6 for each reservoir cycle throughout each 12-week treatment period
measure: Hyperglycemic Episode Rate Per 30 Days
timeFrame: Days 1-6 for each reservoir cycle throughout each 12-week treatment period
measure: Percentage of Participants With Pump Complications
timeFrame: Days 1-6 for each reservoir cycle throughout each 12-week treatment period
measure: Pump Complications Rate Per 30 Days
timeFrame: Days 1-6 for each reservoir cycle throughout each 12-week treatment period
measure: Percentage of Participants Having a Hypoglycemic Episode
timeFrame: All days for each reservoir cycle throughout each 12-week treatment period
measure: Hypoglycemic Episode Rate Per 30 Days
timeFrame: All days for each reservoir cycle throughout each 12-week treatment period
measure: Change From Baseline to 12 Week Endpoint for Each Treatment in Weight
timeFrame: Baseline, endpoint for each 12-week treatment period
measure: Change From Baseline to 12 Weeks Endpoint for Each Treatment in Blood Pressure
timeFrame: Baseline, endpoint for each 12-week treatment period
Locations:
city: Caen
country: France
facility: 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.
city: Corbeil-Essonnes
country: France
facility: 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.
city: La Rochelle
country: France
facility: 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.
city: Marseille
country: France
facility: 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.
city: Montpellier
country: France
facility: 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.
city: Narbonne
country: France
facility: 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.
city: Ludwigshafen
country: Germany
facility: 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.
city: Mainz
country: Germany
facility: 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.
city: Münster
country: Germany
facility: 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.
city: Neuwied
country: Germany
facility: 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.
city: Potsdam
country: Germany
facility: 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.
city: Bekescsaba
country: Hungary
facility: 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.
city: Budapest
country: Hungary
facility: 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.
city: Nyiregyhaza
country: Hungary
facility: 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.
city: Zalaegerszeg
country: Hungary
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: