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OpenTrials
Completed

NCT Number: NCT01134107

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

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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Key information

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insulin Lispro 6 Day (6D)

Drug

Administered by infusion pump for 12 week treatment period

Other names: Insulin Lispro Formulation, Humalog, LY275585

Insulin Aspart 6 Day (6D)

Drug

Administered by infusion pump for 12 week treatment period

Primary outcomes

  1. 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 outcomes

  1. Mean SMBG

    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.

  2. Mean Daily Insulin Dose (Total, Basal, and Bolus)

    Time frame: Days 1-6 for each reservoir cycle throughout each 12-week treatment period

  3. 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

  4. 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 outcomes

  1. Change From Baseline to 12 Weeks for Daily Insulin Dose (Total, Basal, and Bolus)

    Time frame: Baseline, endpoint for each 12-week treatment period

  2. Percentage of Participants Having a Hyperglycemic Episode

    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

  3. Hyperglycemic Episode Rate Per 30 Days

    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.

  4. Percentage of Participants With Pump Complications

    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.

  5. Pump Complications Rate Per 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.

  6. Percentage of Participants Having a Hypoglycemic Episode

    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

    • reported signs and symptoms of hypoglycemia, and/or
    • a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L)
  7. Hypoglycemic Episode Rate Per 30 Days

    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

    • reported signs and symptoms of hypoglycemia, and/or
    • a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L)
  8. Change From Baseline to 12 Week Endpoint for Each Treatment in Weight

    Time frame: Baseline, endpoint for each 12-week treatment period

  9. Change From Baseline to 12 Weeks Endpoint for Each Treatment in Blood Pressure

    Time frame: Baseline, endpoint for each 12-week treatment period

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 31, 2010
Registry last updated
Apr 11, 2013

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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