a study to compare a new long-acting insulin (ly2605541) and human insulin nph in participants with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to compare ly2605541 and human insulin isophane suspension (nph) using the following measures for participants treated for up to 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 night time blood sugar episodes * the total number of low blood sugar episodes reported


Eligibility criteria:
inclusion criteria: * have had type 2 diabetes mellitus for at least 1 year, not treated with insulin * have been receiving 2 or more oams for at least 3 months prior to the study * have a hemoglobin a1c (hba1c) of 7.0% to 11.0%, inclusive, 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 are not breastfeeding, have a negative pregnancy test at screening and randomization, do not plan to become pregnant during the study, 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 used insulin therapy in the past 2 years (except for use during pregnancy or for short term use for acute conditions) * have been treated with glucagon-like peptide-1 (glp-1) receptor agonist, rosiglitazone, pramlintide, or weight-loss medication within 3 months before 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 before screening, prescription or over-the-counter medications to promote weight loss * have had any episodes of severe hypoglycemia, diabetic ketoacidosis, or hyperosmolar state/coma within 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) \[177 millimoles per liter (mmol/l)\] * have obvious clinical signs or symptoms of liver disease \[excluding nonalcoholic fatty liver disease (nafld)\], acute or chronic hepatitis, nonalcoholic 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 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 * are using or have used any of the following lipid-lowering medications: niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening