a study of ly2605541 in participants with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to compare ly2605541 and insulin glargine using the following measures after participants have been treated for 26 weeks: * change in participants' overall blood sugar control * the rate of night time low blood sugar episodes * the number of participants that reach blood sugar targets without low blood sugar episodes at night * the rate of low blood sugar episodes reported over a 24-hour period


Eligibility criteria:
inclusion criteria: * have had type 2 diabetes mellitus for at least 1 year * have been receiving basal insulin (neutral protamine hagedorn \[nph\], detemir, or glargine) and a stable dose of 0 to 3 oral antihyperglycemic medications (oams) used as specified in the local prescribing information for at least 90 days prior to screening. at least 1 of the oams must be dosed at, or above, half the maximum daily dose allowed by local regulations or at the maximally tolerated dose * have a hemoglobin a1c (hba1c) less than or equal to 9.0% at screening * have a body mass index (bmi) less than or equal to 45.0 kilograms per square meter (kg/m\^2) * women of childbearing potential who are not breastfeeding, have a negative pregnancy test at screening and randomization, do not plan to become pregnant during the study, and have practiced reliable birth control for at least 6 weeks prior to screening and will continue to do so during the study and until 2 weeks after the last dose of study drug exclusion criteria: * have routinely used insulin glargine twice daily in the 90 days prior to the study or have used routine, mealtime insulin therapy (outside of pregnancy) anytime in the past 6 months, except for short-term treatment up to a maximum of 4 continuous weeks * have used rosiglitazone, pramlintide, glucagon-like peptide 1 (glp-1) receptor agonist concurrently or within 90 days prior to screening * for participants on oams: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations * are taking, or have taken within the 90 days preceding screening, prescription or over-the-counter medications to promote weight loss * have had any episodes of severe hypoglycemia within 6 months prior to screening * have had 1 or more episodes of diabetic ketoacidosis or hyperosmolar state/coma in the 6 months prior to screening * have cardiac disease with functional status that is new york heart association class iii or iv * have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater than or equal to 2 milligrams per deciliter (mg/dl) (177 micromoles per liter \[µmol/l\]) * 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 * 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 measurement of hba1c * have active or untreated cancer, have been in remission from clinically significant cancer(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 * are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intranasal, intraocular, and inhaled preparations) or have received such therapy within the 8 weeks immediately preceding screening * have fasting triglycerides greater than 400 mg/dl (4.5 millimoles per liter \[mmol/l\]) at screening * have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night) in the investigator's opinion * lipid-lowering medication: are using or have used any of the following: * niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening or * lipid-lowering medication at a dose that has not been stable for at least 90 days prior to screening