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Insulin Lispro 6 Days Versus Insulin Aspart 6 Days in Pump Use

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ClinicalTrials.gov Identifier: NCT01109316
Recruitment Status : Completed
First Posted : April 23, 2010
Results First Posted : October 30, 2012
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE April 19, 2010
First Posted Date  ICMJE April 23, 2010
Results First Submitted Date  ICMJE August 8, 2012
Results First Posted Date  ICMJE October 30, 2012
Last Update Posted Date March 27, 2019
Study Start Date  ICMJE April 2010
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2012)
Mean of Last Five 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Day 2 for Insulin Lispro 2D and Day 6 for Insulin Aspart 6D Pump Reservoir In-use [ Time Frame: 8 weeks of each treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 21, 2010)
Mean of last five 7-point Self Monitored Blood Glucose (SMBG) taken on day 6 for 6D and day 2 for 2D insulin lispro and day 6 for 6D insulin aspart pump reservoir in-use [ Time Frame: 8 weeks of each treatment ]
Change History Complete list of historical versions of study NCT01109316 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2012)
  • Mean SMBG [ Time Frame: 8 weeks for each treatment ]
    Mean SMBG for combined periods; all reported SMBG values on days 1-6 for Insulin Lispro 6 Day and Insulin Aspart 6 Day, and days 1-2 for Insulin Lispro 2 Day.
  • Mean Daily Insulin Dose (Total, Basal, and Bolus) [ Time Frame: 8 weeks for each treatment ]
  • Change From Baseline to 8 Weeks Endpoint for Each Treatment in Hemoglobin A1c (HbA1c) Values [ Time Frame: Baseline, 8 weeks for each treatment ]
  • Number of Participants Who Achieve or Maintain an HbA1c Less Than or Equal to 6.5% and Less Than 7% [ Time Frame: 8 weeks for each treatment ]
  • Percentage of Participants With Hyperglycemia [ Time Frame: 8 weeks for each treatment ]
    Hyperglycemia was defined as an event with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 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.
  • Hyperglycemic Episode Rate Per 30 Days [ Time Frame: 8 weeks for each treatment ]
    Hyperglycemia was defined as an episode with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 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.
  • Percentage of Participants With Pump Complications [ Time Frame: 8 weeks for each treatment ]
    Overall Pump Complications were any combination of: tubing clogged, kinked, disconnected, pulled out, blood in tubing; too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm; at site - skin abscess, excessive redness, swelling (not nodule), bleeding, bruising; 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 change was early (prior to 6 days for L6D or A6D, or prior to 2 days for L2D). If 'yes', then recorded as premature change.
  • Pump Complication Rate Per 30 Days [ Time Frame: 8 weeks for each treatment ]
    Overall Pump Complications were any combination of: tubing clogged, kinked, disconnected, pulled out, blood in tubing; too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm; at site - skin abscess, excessive redness, swelling (not nodule), bleeding, bruising; 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 change was early (prior to 6 days for L6D or A6D, or prior to 2 days for L2D). If 'yes', then recorded as premature change.
  • Percentage of Participants With Hypoglycemia [ Time Frame: 8 weeks for each treatment ]
    Hypoglycemia was defined as an event which was 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).
  • Hypoglycemia Episode Rate Per 30 Days [ Time Frame: 8 weeks for each treatment ]
    Hypoglycemia was defined as an event which was 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). Rate is presented as the number of hypoglycemic episodes adjusted for 30 days.
  • Change From Baseline to 8 Weeks Endpoint for Each Treatment in Weight [ Time Frame: Baseline, 8 weeks for each treatment ]
  • Change From Baseline to 8 Weeks Endpoint for Each Treatment in Blood Pressure [ Time Frame: Baseline, 8 weeks for each treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2010)
  • Mean SMBG [ Time Frame: 8 weeks for each treatment ]
  • Mean Daily Insulin Dose (Total, Basal, and Bolus) [ Time Frame: 8 weeks for each treatment ]
  • Change From Baseline to 8 Weeks Endpoint for Each Treatment in Hemoglobin A1c (HbA1c) Values [ Time Frame: Baseline, 8 weeks for each treatment ]
  • Proportion of patients who achieve or maintain an HbA1c less than or equal to 6.5% and less than 7% [ Time Frame: 8 weeks for each treatment ]
  • Incidence and rate of hyperglycemia [ Time Frame: 8 weeks for each treatment ]
  • Incidence and rate of pump complications [ Time Frame: 8 weeks for each treatment ]
  • Incidence and rate of hypoglycemia [ Time Frame: 8 weeks for each treatment ]
  • Change From Baseline to 8 Weeks Endpoint for Each Treatment in Weight [ Time Frame: Baseline, 8 weeks for each treatment ]
  • Change From Baseline to 8 Weeks Endpoint for Each Treatment in Blood Pressure [ Time Frame: Baseline, 8 weeks for each treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Insulin Lispro 6 Days Versus Insulin Aspart 6 Days in Pump Use
Official Title  ICMJE An Open-Label, Randomized, Crossover Trial of CSII Reservoir In-use Comparing Insulin Lispro Formulation to Insulin Aspart in Patients With Type 1 Diabetes Mellitus
Brief Summary This is a 6-sequence, 3-period (8 weeks each), 3-arm, 24-week crossover study. The purpose of this study is to provide information on the use of insulin lispro in insulin pumps (Continuous Subcutaneous Insulin Infusion [CSII]) compared to insulin aspart over 6 days of pump reservoir in-use. The study will also compare the in-use characteristics of insulin lispro infused at 6 days with insulin lispro infused at 2 days.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 1
Intervention  ICMJE
  • Drug: Insulin lispro 2 day reservoir in-use
    Insulin lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
    Other Names:
    • LY275585
    • Humalog
  • Drug: Insulin lispro 6 day reservoir in-use
    Insulin lispro 6 Day (L6D) administered by infusion pump for 8 week treatment period.
    Other Names:
    • LY275585
    • Humalog
  • Drug: Insulin aspart 6 day reservoir in-use
    Insulin aspart 6 Day (A6D) administered by infusion pump for 8 week treatment period.
Study Arms  ICMJE
  • Active Comparator: Insulin Lispro 2 Day
    Intervention: Drug: Insulin lispro 2 day reservoir in-use
  • Experimental: Insulin Lispro 6 Day
    Intervention: Drug: Insulin lispro 6 day reservoir in-use
  • Active Comparator: Insulin Aspart 6 Day
    Intervention: Drug: Insulin aspart 6 day reservoir in-use
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 21, 2010)
132
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosed with type 1 diabetes (World Health Organization criteria) for at least 24 months.
  • Treated with continuous subcutaneous insulin infusion therapy for the previous 6 months.
  • Mean total daily insulin dose for 3 days prior to screening equal to or less than 46 units/day using a 300-unit reservoir or less than or equal to 26 units/day using a 180 unit reservoir.
  • Baseline body mass index (BMI) less than or equal to 35.0 kg/m^2.
  • Baseline glycosylated hemoglobin (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 of hypoglycemic coma, seizures, or disorientation in the 12 months prior to screening.
  • Have had hypoglycemia unawareness (routinely asymptomatic at blood glucose (BG) less than 45 mg/dL) 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.
  • Patients 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 3 months prior to screening, or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with HbA1c methodology.
  • Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, intraocular and inhaled prescriptions), or have received such therapy within the 4 weeks immediately preceding screening.
  • Have an irregular sleep/wake cycle (for example, patients who sleep during the day and work during the night), in the investigator's opinion.
  • Have 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 an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
  • Have previously completed or withdrawn from this study after having signed the informed consent document (ICD).
  • Are unwilling or unable to comply with the use of a data collection device to directly record data from the patient.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Puerto Rico
 
Administrative Information
NCT Number  ICMJE NCT01109316
Other Study ID Numbers  ICMJE 12174
F3Z-MC-IOPV ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9am - 5pm Eastern (UTC/GMT - 5hrs, EST) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP