- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01134107
Insulin Lispro 6 Days Versus Insulin Aspart 6 Days in Pump Use
April 4, 2013 updated by: Eli Lilly and Company
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
133
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Caen, France, 14033
- 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.
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Corbeil-Essonnes, France, 91106
- 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.
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La Rochelle, France, 17019
- 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.
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Marseille, France, 13009
- 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.
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Montpellier, France, 34295
- 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.
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Narbonne, France, 11108
- 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.
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Ludwigshafen, Germany, 67059
- 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.
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Mainz, Germany, 55116
- 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.
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Münster, Germany, 48145
- 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.
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Neuwied, Germany, 56564
- 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.
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Potsdam, Germany, 14469
- 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.
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Bekescsaba, Hungary, 5600
- 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.
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Budapest, Hungary, 1023
- 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.
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Nyiregyhaza, Hungary, 4400
- 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.
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Zalaegerszeg, Hungary, 8900
- 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.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Insulin Lispro 6 Day (6D)
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Administered by infusion pump for 12 week treatment period
Other Names:
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ACTIVE_COMPARATOR: Insulin Aspart 6 Day (6D)
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Administered by infusion pump for 12 week treatment period
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
Time Frame: Day 6 of each reservoir cycle for the last 6 weeks of each 12-week treatment period (Week 7 through Week 12)
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Day 6 of each reservoir cycle for the last 6 weeks of each 12-week treatment period (Week 7 through Week 12)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Mean SMBG
Time Frame: Days 1-6 and Day 2 and Day 6 for each reservoir cycle throughout each 12-week treatment period
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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.
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Days 1-6 and Day 2 and Day 6 for each reservoir cycle throughout each 12-week treatment period
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Mean Daily Insulin Dose (Total, Basal, and Bolus)
Time Frame: Days 1-6 for each reservoir cycle throughout each 12-week treatment period
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Days 1-6 for each reservoir cycle throughout each 12-week treatment period
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Change From Baseline to 12 Weeks for Each Treatment in Glycated Hemoglobin A1c (HbA1c) Values
Time Frame: Baseline, endpoint for each 12-week treatment period
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Baseline, endpoint for each 12-week treatment period
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Number of Participants Who Achieve or Maintain a Glycated Hemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than 7%
Time Frame: Endpoint for each 12-week treatment period
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Endpoint for each 12-week treatment period
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline to 12 Weeks for Daily Insulin Dose (Total, Basal, and Bolus)
Time Frame: Baseline, endpoint for each 12-week treatment period
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Baseline, endpoint for each 12-week treatment period
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Percentage of Participants Having a Hyperglycemic Episode
Time Frame: Days 1-6 for each reservoir cycle throughout each 12-week treatment period
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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
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Days 1-6 for each reservoir cycle throughout each 12-week treatment period
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Hyperglycemic Episode Rate Per 30 Days
Time Frame: Days 1-6 for each reservoir cycle throughout each 12-week treatment period
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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.
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Days 1-6 for each reservoir cycle throughout each 12-week treatment period
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Percentage of Participants With Pump Complications
Time Frame: Days 1-6 for each reservoir cycle throughout each 12-week treatment period
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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.
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Days 1-6 for each reservoir cycle throughout each 12-week treatment period
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Pump Complications Rate Per 30 Days
Time Frame: Days 1-6 for each reservoir cycle throughout each 12-week treatment period
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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.
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Days 1-6 for each reservoir cycle throughout each 12-week treatment period
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Percentage of Participants Having a Hypoglycemic Episode
Time Frame: All days for each reservoir cycle throughout each 12-week treatment period
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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
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All days for each reservoir cycle throughout each 12-week treatment period
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Hypoglycemic Episode Rate Per 30 Days
Time Frame: All days for each reservoir cycle throughout each 12-week treatment period
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All Reported Hypoglycemic Episodes are defined as an event which is associated with
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All days for each reservoir cycle throughout each 12-week treatment period
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Change From Baseline to 12 Week Endpoint for Each Treatment in Weight
Time Frame: Baseline, endpoint for each 12-week treatment period
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Baseline, endpoint for each 12-week treatment period
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Change From Baseline to 12 Weeks Endpoint for Each Treatment in Blood Pressure
Time Frame: Baseline, endpoint for each 12-week treatment period
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Baseline, endpoint for each 12-week treatment period
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (ACTUAL)
December 1, 2011
Study Completion (ACTUAL)
December 1, 2011
Study Registration Dates
First Submitted
May 27, 2010
First Submitted That Met QC Criteria
May 27, 2010
First Posted (ESTIMATE)
May 31, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
April 11, 2013
Last Update Submitted That Met QC Criteria
April 4, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12175
- F3Z-MC-IOPW (OTHER: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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