Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

Hemoglobin A1c (HbA1c) at 12 Weeks
HbA1c is a test that measures a person's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis including the following fixed effects: treatment, period, sequence, baseline HbA1c (last nonmissing value at or before randomization), week (defined from the start of each Randomization Period), and treatment-by-week interaction.
At 12 Week in Each Randomization Period

Secondary Outcomes (17)

30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events
Baseline (Day 1) of Randomization Period through 24 Weeks (12 weeks in each Randomization Period)
Percentage of Participants With Total and Nocturnal Hypoglycemic Events
Baseline (Day 1) of Randomization Period through 24 weeks (12 weeks in each Randomization Period)
Fasting Blood Glucose (FBG) Measured by Self-Monitored Blood Glucose
At 12 Weeks in Each Randomization Period
Intra-Participant Variability of FBG at 12 Weeks
At 12 Weeks in Each Randomization Period
Fasting Serum Glucose (FSG) at 12 Weeks
At 12 Weeks in Each Randomization Period
+12 more secondary outcomes

Study Arms (2)

LY2605541 Fixed Time Dosing

EXPERIMENTAL

Participant-specific dose of LY2605541 administered subcutaneously (SQ) at approximately the same time every evening for 12 weeks in the Lead-in Period and in Randomization Period 1 or Randomization Period 2. Participant-specific dose of insulin lispro SQ when \>20% of calories were consumed (pre-meal). Insulin dose and adjustments to insulin dose were determined by insulin algorithms based on self-monitored blood glucose (SMBG). Target glucose values were as follows: Preprandial and bedtime BG between 71 and 130 milligrams/deciliter (mg/dL) Insulin adjustment and glucose correction between 71 and 100 mg/dL.

Drug: LY2605541Drug: Insulin Lispro

LY2605541 Variable Time Dosing

EXPERIMENTAL

Participant-specific dose of LY2605541 administered SQ on a variable time schedule (8- and 40-hour dosing intervals) for 12 weeks in Randomization Period 1 or Randomization Period 2. Dosing schedules were to remain approximately the same throughout the 12 weeks. Participant-specific dose of insulin lispro SQ when \>20% of calories were consumed (pre-meal). Insulin dose and adjustments to insulin dose were determined by insulin algorithms based on SMBG. Target glucose values were as follows: Preprandial and bedtime BG between 71 and 130 mg/dL Insulin adjustment and glucose correction between 71 and 100 mg/dL.

Drug: LY2605541Drug: Insulin Lispro

Interventions

LY2605541DRUG

Also known as: Insulin Peglispro

LY2605541 Fixed Time DosingLY2605541 Variable Time Dosing

Insulin LisproDRUG

All participants will be administering insulin lispro SQ as their pre-meal insulin during the course of the trial.

LY2605541 Fixed Time DosingLY2605541 Variable Time Dosing

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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
+2 more criteria

Contact the study team to confirm eligibility.