The purpose of this study is to measure how much of the study drug or insulin glargine gets
into the blood stream and how long it takes the body to get rid of it. The effect of
exercise will also be evaluated.
This study has two parts. In Part A, each participant will receive a daily injection of
LY2605541 or insulin glargine for about 15 days. Some participants may continue into Part B.
In Part B, participants will receive a daily injection of LY2605541 or insulin glargine with
or without exercise. Part B lasts about 6 days.
Participants will remain on their regular physician-prescribed meal time insulin throughout
the study.
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Inclusion Criteria:
- Are males or females that have had a diagnosis of Type I Diabetes Mellitis (T1DM) for
at least 12 months and are receiving multiple daily insulin injections. Total daily
insulin dose <1. 2 units per kilogram per day (U/kg/day); daily basal dose >0. 2
U/kg/day
- Female participants are women of child-bearing potential who test negative for
pregnancy at the time of enrollment based on a urine pregnancy test and agree to use
a reliable method of birth control during the study
- Have a body mass index (BMI) of 18 to 30 kilograms per meter square (kg/m^2),
inclusive
- Have a fasting c-peptide <0. 3 nanomoles per liter (nmol/L)
- Have a hemoglobin A1c (HbA1c) < 9% at screening
Participants with T1DM are eligible for enrollment in Part B of the study only if they
meet all of the following criteria:
- Have a maximal oxygen uptake (VO2 max) of ≥ 25 milliliters (ml) of oxygen per
kilogram per minute (O2/kg/min) (for women) or ≥ 30 ml O2/kg/min (for men)
- Perform regular physical cardiorespiratory activity to achieve an average total
energy expenditure of ≥ 500 metabolic equivalent of task (MET)-minutes per week
during the last 3 months prior to screening
Exclusion Criteria:
- Have known allergies to LY2605541, insulin glargine, related compounds or any
components of the formulation
- Have a history of or current cardiovascular, respiratory, hepatic, renal,
gastrointestinal, endocrine (apart from type 1 diabetes), hematological, or
neurological disorders capable of significantly altering the absorption, metabolism,
or elimination of drugs; of constituting a risk when taking the study medication; or
of interfering with the interpretation of data
- Have had episodes of severe hypoglycemia in the past 6 months (severe hypoglycemia is
defined as having neurological symptoms consistent with neuroglycopenia and having
required assistance in treatment by a second party)
- Have a history of hypoglycemia unawareness
- Regular use or intended use of any over-the-counter or prescription medications or
nutritional supplements that may affect blood glucose or the body's sensitivity to
insulin or that promote weight loss within 14 days prior to dosing
- Have an average weekly alcohol intake that exceeds 21 units per week (males up to age
65) and 14 units per week (males over 65 and females), or are unwilling to comply
with study requirements regarding alcohol consumption
- Currently smokes > 5 cigarettes per day, or are unwilling to comply with study
requirements regarding smoking or use of tobacco products
- Have a hemoglobin level <8. 0 millimoles per liter (mmol/L) (male) or <6. 4 mmol/L
(female) at screening
- Are currently participating in a weight loss program or plan to do so during the
course of the study
- Are receiving chronic (lasting longer than 14 consecutive days) systemic
glucocorticoid therapy (excluding topical, intra-articular, and intraocular
preparations) or have received such therapy within the 4 weeks before dosing
- Have fasting triglycerides >400 milligrams per deciliter (mg/dL) (4. 52 mmol/l)
- Have previous history or family history of deep vein thrombosis