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



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:13 - Any
Updated:3/29/2019
Start Date:April 2010
End Date:August 2011

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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

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.


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.
We found this trial at
11
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Nashua, NH
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Syracuse, NY
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Topeka, KS
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West Palm Beach, FL
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