a study in patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is: * to compare blood sugar control on ly2605541 with insulin glargine after 52 weeks of treatment. * to compare the rate of night time low blood sugar episodes on ly2605541 with insulin glargine during 52 weeks of treatment. * to compare the number of participants on ly2605541 reaching blood sugar targets without low blood sugar episodes at night to those taking insulin glargine after 52 weeks of treatment. * to compare the rate of low blood sugar episodes on ly2605541 with insulin glargine after 52 weeks of treatment


Eligibility criteria:
inclusion criteria: * have type 2 diabetes mellitus, not treated with insulin, for at least 1 year prior to the study * have been receiving at least 2 oams for at least 3 months before entering the study * have a hemoglobin a1c (hba1c) value between 7.0% and 11.0%, inclusive, at screening * are capable of and willing to inject insulin with a vial and syringe and perform self blood glucose monitoring * women of childbearing potential only: are not breastfeeding, have a negative pregnancy test at the time of screening and randomization, intend to not become pregnant during the trial, have practiced a reliable method of birth control for at least 6 weeks prior to screening, and agree to use a reliable method of birth control during the study and until 2 weeks following the last dose of study drug exclusion criteria: * have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 continuous weeks * use of rosiglitazone, pramlintide, or glucagon-like peptide 1 (glp-1) receptor agonist (for example, exenatide, exenatide once weekly, or liraglutide) concurrently or within 3 months prior to screening * are currently taking, or have taken within the 3 months preceding screening, 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 ketoacidosis or hyperosmolar state/coma in the 6 months prior to the study * have cardiac disease with functional status that is new york heart association class iii or iv (per new york heart association \[nyha\] cardiac disease classification) * have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater or equal than 2 milligrams per deciliter (mg/dl) * 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 at screening * 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 malignancy or have been in remission from clinically significant malignancy for less than 5 years * have fasting or non-fasting triglycerides greater than 400 mg/dl (greater than 4.5 millimoles per liter \[mmol/l\]) at screening * are using lipid-lowering medication at a dose that has not been stable for 90 days prior to screening * are using niacin preparations as a lipid lowering medication and bile acid sequestrants within 90 days prior to screening

Keywords: diabetes mellitus type 2 diabetes mellitus insulin naive insulin treatment