The Impact of LY2605541 versus Insulin Glargine for Patients with Type 1 Diabetes Mellitus Treated with Preprandial Insulin Lispro:An Open-Label, Randomized, 78-Week Study (IMAGINE 1)
- Conditions
- Diabetes Mellitus, Type 1
- Registration Number
- JPRN-jRCT2080221675
- Lead Sponsor
- Eli Lilly Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- Not specified
*Have had diabetes for at least 1 year
*Have an HbA1c value less than 12% according to the central laboratory at screening
*Have a body mass index (BMI) less than or equal to 35.0 kg/m^2
*Have been treated for at least 90 days prior to screening with:
-insulin detemir, insulin glargine, or human insulin isophane suspension (NPH) insulin in combination with premeal insulin, or
-self-mixed or premixed insulin regimens with any basal and bolus insulin combination administered at least twice daily, or
-continuous subcutaneous insulin infusion therapy
*This inclusion criterion applies to all females
-Are not breastfeeding
-Test negative for pregnancy at screening and randomization based on a serum pregnancy test
-Intend not to become pregnant during the study
-Have practiced a reliable method of birth control (for example, use of oral contraceptives or levonorgestrel; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) for at least 6 weeks prior to screening
-Agree to continue to use a reliable method of birth control during the study, as determined by the investigator (and for 2 weeks following the last dose of study drug)
*Capable of, willing and desirous to do the following: adhere to a multiple daily injection regimen, inject insulin with a prefilled pen and perform Self-Monitored Blood Glucose (SMBG) and record keeping as required by this protocol, as determined by the investigator. Caregiver may do all of the above.
*Are using twice daily insulin glargine having been inadequately controlled on single daily dosed glargine prior to screening
*Excessive insulin resistance defined as having received a total daily dose of insulin greater than 1.5 U/kg at the time of randomization
*Receiving any oral or injectable medication (other than metformin for treatment of polycystic ovarian disease) intended for the treatment of diabetes mellitus other than insulins in the 90 days prior to screening
*Lipid-lowering medications:
-are using niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening; or,
-are using lipid-lowering medication at a dose that has not been stable for greater than or equal to 90 days prior to screening If a participant has not been on a stable dose of lipid-lowering medication for greater than or equal to 90 days prior to screening, the site should wait to screen the participant. If the results of the screening laboratory tests require a change to the participant's current lipid-lowering medication or initiation of lipid-lowering medication, it is acceptable to change the lipid-lowering medication for the participant and have the participant return greater than or equal to 90 days later to complete some of the screening procedures again
*Have fasting hypertriglyceridemia (defined as greater than 4.5 mmol/L, greater than 400 mg/dl) at screening, as determined by the central laboratory
*Have had more than 1 episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia as determined by the investigator) within 6 months prior to entry into the study
*Have had 2 or more emergency room visits or hospitalizations due to poor glucose control (hyperglycemia or diabetic ketoacidosis) in the past 6 months
*Cardiovascular: have cardiac disease with functional status that is New York Heart Association Class III or IV (per NYHA Cardiac Disease Classification)
*Renal: Have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine greater than 2.5 mg/dL
*Hepatic: have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic fatty liver disease [NAFLD]), acute or chronic hepatitis, non alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements as indicated below:
-total bilirubin greater than or equal to 2 times the upper limit of normal (ULN) as defined by the central laboratory, or
-alanine aminotransferase (ALT)/(serum glutamic pyruvic transaminase (SGPT) greater than 2.5 times ULN as defined by the central laboratory, or
-aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) greater than 2.5 times ULN as defined by the central laboratory
*Malignancy: Have active or untreated malignancy, have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
*Allergy: Have known hypersensitivity or allergy to any of the study insulins or their excipients
*Hematologic: 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 the HbA1c measurement
*Glucocorticoid therapy: Receiving chronic (lasting longer than 1
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method