A Study of LY2605541 in Participants With Type 1 Diabetes Mellitus

This study involved a comparison of LY2605541 regimens, each administered with bolus insulin
lispro. Eligible participants were switched to a fixed evening LY2605541dosing regimen at the
beginning of the 12-week lead-in period. LY2605541 was administered SQ once-daily using a
prefilled insulin device. The LY2605541dose was adjusted using a dosing algorithm adapted
from Bartley and Bolli (Bartley et al. 2008, Bolli et al. 2009) based on the participant's
blood glucose (BG) values and documented hypoglycemia during the previous week. Participants
not already receiving insulin lispro for prandial dosing were switched to insulin lispro at
the beginning of the 12-week lead-in period. Adjustments to insulin lispro doses were based
on the insulin dosing algorithms adapted from Riddle and Bergenstal (Riddle et al. 2003,
Bergenstal et al. 2008). At the time of randomization, participants were randomized to begin
either the fixed evening dosing regimen or the variable time dosing regimen. Each participant
was crossed over to the alternate regimen after 12 weeks. The insulin device (prefilled pen)
remained the same throughout the study.

Inclusion Criteria:

- Type 1 diabetes mellitus for at least 1 year

- Have an HbA1c value <9.0%

- Have a body mass index (BMI) ≤35.0 kilogram per square meter (kg/m^2)

- Currently using basal/ bolus insulin

- Women of childbearing potential are not breastfeeding and must use methods to prevent
pregnancy

Exclusion Criteria:

- Have excessive insulin resistance

- Are taking medications other than insulin for diabetes

- High triglycerides

- 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

- Have cardiac disease with functional status that is New York Heart Association (NYHA)
Class III or IV (per NYHA Cardiac Disease Classification)

- Have impaired renal function

- Have impaired liver function

- Have had a blood transfusion or severe blood loss within 3 months prior to screening
or have known hemoglobinopathy, hemolytic anemia, sickle cell anemia, or any other
traits of hemoglobin abnormalities known to interfere with HbA1c measurement

- Have cancer, recent cancer, or risk of cancer

- Have a known hypersensitivity or allergy to any of the study insulins or their
excipients

- Have chronic systemic glucocorticoid users

- Have clinically significant diabetic autonomic neuropathy

- Have irregular sleep/wake cycle

- Have been treated with a drug within the last 30 days that has not received regulatory
approval at the time of study entry

- Prior study participation

- Are using or have used niacin preparations as a lipid-lowering medication and/or bile
acid sequestrants within 90 days prior to screening