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
- Type 1 Diabetes MellitusMedDRA version: 14.1Level: SOCClassification code 10027433Term: Metabolism and nutrition disordersSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2011-001261-40-IT
- Lead Sponsor
- ELI LILLY
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 455
[1] Have had T1DM based on the World Health Organization (WHO) classification [2] Are at least 18 years of age [3] Duration of diabetes = 1 year [4] Have an HbA1c value < 12% according to the central laboratory at screening [5] Body mass index = 35.0 kg/m2 [6] Have been treated for at least 90 days prior to screening with insulin (glargine, NPH, or detemir) in combination with pre-meal insulin, or self mixed or pre-mixed insulin regimens with any basal and bolus insulin combination administered at least twice daily, or continuous subcutaneous insulin infusion therapy [7] Female patients who are not breastfeeding, test negative for pregnancy at the time of screening and enrollment based on a serum pregnancy test, intend not to become pregnant during the study and have practiced a reliable method of birth control for at least 6 weeks prior to screening; agree to continue to use a reliable method of birth control during the study and for 2 weeks following the last dose of study drug. [8] Have access to a telephone [9] Have refrigeration in the home [10] 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 blood glucose monitoring and record keeping as required by this protocol, as determined by the investigator. Caregiver may do all of the above. [11] Have given written informed consent to participate in this study in accordance with local regulations.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 428
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22
[12] Are using twice daily insulin glargine having been inadequately controlled on single daily dosed glargine prior to screening. [13] Excessive insulin resistance defined as having received a total daily dose of insulin > 1.5 U/kg at the time of randomization. [14] 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. Note: for subjects on metformin, the following exclusion criteria will apply: have serum creatinine concentration that contraindicates metformin use per the country-specific product labeling; [15] 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 = 90 days prior to screening. [16] Have fasting hypertriglyceridemia (defined as >4.5 mmol/L, <400 mg/dl) at screening, as determined by the central laboratory. [17] 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. [18] Have had 2 or more emergency room visits or hospitalizations due to poor glucose control (hyperglycemia or DKA) in the past 6 months. [19] Cardiovascular: have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association [NYHA] Cardiac Disease Classification). [20] Renal: have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine > 2.5 mg/dL. [21] 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 of: total bilirubin (=2 x ULN), or alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) >2.5x ULN as defined by the central laboratory or aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) > 2.5 x ULN as defined by the central laboratory. [22] 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.[23] Allergy: have known hypersensitivity or allergy to any of the study insulins or their excipients. [24] 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.[25] Glucocorticoid therapy: receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, and inhaled preparations) or have received such therapy within 8 weeks immediately before screening with the exception of replacement therapy for adrenal insufficiency [26] Diagnosed clinically significant diabetic autonomic neuropathy, in the opinion of the investigator. [27] Have any other condition (including known drug or alcohol abuse or
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method