Conditions

Diabetes Mellitus, Type 1

Outcome Measures

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
Day 6 of each reservoir cycle for the last 6 weeks of each 12-week treatment period (Week 7 through Week 12)

Secondary Outcomes (4)

Mean SMBG
Days 1-6 and Day 2 and Day 6 for each reservoir cycle throughout each 12-week treatment period
Mean Daily Insulin Dose (Total, Basal, and Bolus)
Days 1-6 for each reservoir cycle throughout each 12-week treatment period
Change From Baseline to 12 Weeks for Each Treatment in Glycated Hemoglobin A1c (HbA1c) Values
Baseline, endpoint for each 12-week treatment period
Number of Participants Who Achieve or Maintain a Glycated Hemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than 7%
Endpoint for each 12-week treatment period

Other Outcomes (9)

Change From Baseline to 12 Weeks for Daily Insulin Dose (Total, Basal, and Bolus)
Baseline, endpoint for each 12-week treatment period
Percentage of Participants Having a Hyperglycemic Episode
Days 1-6 for each reservoir cycle throughout each 12-week treatment period
Hyperglycemic Episode Rate Per 30 Days
Days 1-6 for each reservoir cycle throughout each 12-week treatment period
+6 more other outcomes

Study Arms (2)

Insulin Lispro 6 Day (6D)

EXPERIMENTAL

Drug: Insulin Lispro 6 Day (6D)

Insulin Aspart 6 Day (6D)

ACTIVE COMPARATOR

Drug: Insulin Aspart 6 Day (6D)

Interventions

Insulin Lispro 6 Day (6D)DRUG

Administered by infusion pump for 12 week treatment period

Also known as: Insulin Lispro Formulation, Humalog, LY275585

Insulin Lispro 6 Day (6D)

Insulin Aspart 6 Day (6D)DRUG

Administered by infusion pump for 12 week treatment period

Insulin Aspart 6 Day (6D)

Eligibility Criteria

Age13 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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%

You may not qualify if:

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
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.
+1 more criteria

Contact the study team to confirm eligibility.