A Study in Participants With Type 1 Diabetes Mellitus



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:Any
Updated:11/11/2012
Start Date:January 2012
End Date:June 2014
Contact:There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or
Phone:1-317-615-4559

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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 - The IMAGINE 1 Study


The purpose of this study is:

- To compare the blood sugar control of LY2605541 with insulin glargine after 78 weeks of
treatment.

- To compare the number of night time low blood sugar episodes on LY2605541 with insulin
glargine during 78 weeks of treatment.

- To compare the number of participants on LY2605541 reaching blood sugar targets without
low blood sugar episodes at night to those taking insulin glargine after 78 weeks of
treatment.

- To compare the total number of low blood sugar episodes on LY2605541 with insulin
glargine after 78 weeks of treatment.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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 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

- Diagnosed clinically significant diabetic autonomic neuropathy, in the opinion of the
investigator

- Have any other condition (including known drug or alcohol abuse or psychiatric
disorder including eating disorder) that precludes the participant from following and
completing the protocol
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