type 1 diabetes MedDRA version: 12.1 Level: LLT Classification code 10067584 Term: Type 1 diabetes mellitus
Conditions
Interventions
Trade Name: Humalog
Product Name: Humalog
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN LISPRO
CAS Number: 133107-64-9
Current Sponsor code: LY275585
Concentration unit: U/m
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1] Diagnosed with type 1 diabetes (World Health Organization [WHO] criteria) for at least 24 months. [2] Age >= 13 years. [3] Treated with CSII therapy for the previous 6 months. [4] Mean total daily insulin dose for 3 days prior to screening =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 7] Currently using continuous glucose monitoring (CGM), unless patients agree to not use their personal CGM during the study. [8] Impaired renal function (serum creatinine >=2.0 mg/dL). [9] Legal blindness. [10] Have had any episode in previous 12 months prior to Visit 1 of hypoglycemic coma, seizures, or disorientation. [11] Have had hypoglycemia unawareness (routinely asymptomatic at BG <45 mg/dL) in the 12 months prior to Visit 1. [12] Have had any emergency room visits or hospitalizations due to poor glucose control in the 12 months prior to Visit 1. [13] Have had a pump-related infusion site abscess in the 12 months prior to Visit 1. [14] Have had multiple, clinically significant occlusions as judged by the investigator. [15] Have had any infection with Staphylococcus aureus in the past 5 years. [16] 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. [17] 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. [18] Have had a blood transfusion or severe blood loss within previous 3 months prior to Visit 1 or have known hemoglobinopathy, hemolytic or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with HbA1c methodology. [19] Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, intra-ocular, and inhaled prescriptions), or have received such therapy within the 4 weeks immediately preceding Visit 1. [20] Have an irregular sleep/wake cycle (for example, patients who sleep during the day and work during the night) in the investigator’s opinion. [21] Have known hypersensitivity or allergy to any of the study insulins or their excipients. [22] 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. [23] Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. [24] Are Lilly employees. [25] 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. [26] Have previously completed or withdrawn from this study after having signed the ICD. [27] Are unwilling or unable to comply with the use of a data collection device to directly record data from the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Day 6 of 6 days (6D) of pump reservoir in-use of Humalog is noninferior to Day 6 of 6D of pump reservoir in-use of insulin aspart with regards to 7-point daily mean SMBG (with a margin of 0.6 mmol/L) 2. Day 6 of 6D of pump reservoir in-use of Humalog is superior to Day 6 of 6D of pump reservoir in-use of insulin apart with regards to 7-point daily mean SMBG ;Secondary Objective: ? Day 6 of 6D Humalog is noninferior to Day 2 of 6D Humalog with regards to mean SMBG (margin = 0.6 mmol/L) ? Compare 6D Humalog to 6D insulin aspart with respect to mean SMBG, insulin dose, hypoglycemic events, pump complications, hyperglycemic events, adverse events (AEs), and HbA1c ? Compare Days 1 through 6 of 6D Humalog to Days 1 through 6 of 6D insulin aspart individually and cumulatively with respect to mean SMBG, insulin dose, hypoglycemic events, pump complications, and hyperglycemic events ? Compare Days 1 through 3 with Days 4 through 6 individually and cumulatively of 6D Humalog and 6D insulin aspart, between and within treatment groups with respect to mean SMBG, insulin dose, hypoglycemic events, pump complications, and hyperglycemic events ? Compare Days 1 and 2 with Days 4 and 5 of 6D Humalog and 6D insulin aspart between and within treatment groups with respect to mean SMBG, insulin dose, hypoglycemic events, pump complications, and hyperglycemic events ;Primary end point(s): | — |
Countries
France, Germany, Hungary, Slovakia
Outcome results
None listed