Insulin Lispro 6 Days Versus Insulin Aspart 6 Days in Pump Use
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Insulin Lispro 6 Day (6D)
Insulin Aspart 6 Day (6D)
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
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.
Sites / 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Insulin Lispro 6 Day (6D)
Insulin Aspart 6 Day (6D)
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Mean Daily Insulin Dose (Total, Basal, and Bolus)
Change From Baseline to 12 Weeks for Each Treatment in Glycated Hemoglobin A1c (HbA1c) Values
Number of Participants Who Achieve or Maintain a Glycated Hemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than 7%
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01134107
Brief Title
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
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
133 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insulin Lispro 6 Day (6D)
Arm Type
Experimental
Arm Title
Insulin Aspart 6 Day (6D)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Insulin Lispro 6 Day (6D)
Other Intervention Name(s)
Insulin Lispro Formulation, Humalog, LY275585
Intervention Description
Administered by infusion pump for 12 week treatment period
Intervention Type
Drug
Intervention Name(s)
Insulin Aspart 6 Day (6D)
Intervention Description
Administered by infusion pump for 12 week treatment period
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
Mean SMBG
Description
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 and Day 2 and Day 6 for each reservoir cycle throughout each 12-week treatment period
Title
Mean Daily Insulin Dose (Total, Basal, and Bolus)
Time Frame
Days 1-6 for each reservoir cycle throughout each 12-week treatment period
Title
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
Title
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
Other Pre-specified Outcome Measures:
Title
Change From Baseline to 12 Weeks for Daily Insulin Dose (Total, Basal, and Bolus)
Time Frame
Baseline, endpoint for each 12-week treatment period
Title
Percentage of Participants Having a Hyperglycemic Episode
Description
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
Title
Hyperglycemic Episode Rate Per 30 Days
Description
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
Title
Percentage of Participants With Pump Complications
Description
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
Title
Pump Complications Rate Per 30 Days
Description
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
Title
Percentage of Participants Having a Hypoglycemic Episode
Description
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
reported signs and symptoms of hypoglycemia, and/or
a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L)
Time Frame
All days for each reservoir cycle throughout each 12-week treatment period
Title
Hypoglycemic Episode Rate Per 30 Days
Description
All Reported Hypoglycemic Episodes are defined as an event which is associated with
reported signs and symptoms of hypoglycemia, and/or
a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L)
Time Frame
All days for each reservoir cycle throughout each 12-week treatment period
Title
Change From Baseline to 12 Week Endpoint for Each Treatment in Weight
Time Frame
Baseline, endpoint for each 12-week treatment period
Title
Change From Baseline to 12 Weeks Endpoint for Each Treatment in Blood Pressure
Time Frame
Baseline, endpoint for each 12-week treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
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
ZIP/Postal Code
91106
Country
France
Facility Name
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
ZIP/Postal Code
17019
Country
France
Facility Name
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
ZIP/Postal Code
13009
Country
France
Facility Name
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
ZIP/Postal Code
34295
Country
France
Facility Name
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
ZIP/Postal Code
11108
Country
France
Facility Name
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
ZIP/Postal Code
67059
Country
Germany
Facility Name
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
ZIP/Postal Code
55116
Country
Germany
Facility Name
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
ZIP/Postal Code
48145
Country
Germany
Facility Name
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
ZIP/Postal Code
56564
Country
Germany
Facility Name
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
ZIP/Postal Code
14469
Country
Germany
Facility Name
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
ZIP/Postal Code
5600
Country
Hungary
Facility Name
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
ZIP/Postal Code
1023
Country
Hungary
Facility Name
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
ZIP/Postal Code
4400
Country
Hungary
Facility Name
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
ZIP/Postal Code
8900
Country
Hungary
12. IPD Sharing Statement
Learn more about this trial
Insulin Lispro 6 Days Versus Insulin Aspart 6 Days in Pump Use
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