A Study of Insulin Peglispro (LY2605541) in Participants With Type 2 Diabetes Mellitus

This is an interventional treatment trial for Diabetes Mellitus, Type 2 Read More

Inclusion Criteria:

• Have T2DM (per World Health Organization [WHO] Classification of Diabetes) not treated with insulin.
• Have had diabetes for at least 1 year.
• Have been receiving at least 2 oral antihyperglycemic medications (OAMs) for at least 3 months prior to the study.
• Have hemoglobin A1c (HbA1c) of 7.0% to 11.0%, inclusive, according to central lab at screening.
• Have body mass index (BMI) ≤40 kilogram/square meter (kg/m^2).
• This inclusion criterion applies to females of child-bearing potential (not surgically sterilized and between menarche and 1-year postmenopausal) only: are not breastfeeding, test negative for a serum pregnancy test, intend not to become pregnant during study or willing to have a reliable method of birth control.

Exclusion Criteria:

• Insulin therapy: 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. Insulin use of any duration during pregnancy is not considered an exclusion criterion.
• Concomitant medications: rosiglitazone, pramlintide, glucagon-like peptide-1 (GLP-1) receptor agonist (for example, exenatide, exenatide once weekly, or liraglutide) used concurrently or within 3 months prior to screening.
• Local OAM restrictions: for participants on OAMs, restrictions for cardiac, renal, hepatic diseases and maximum dose, local product regulations must apply.
• Weight loss medications: are currently taking, or have taken within the 3 months preceding screening, prescription or over-the-counter medications to promote weight loss.
• Severe hypoglycemia history: have had any episodes of severe hypoglycemia within 6 months prior to screening.
• Diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar nonketotic coma (HHNKC): have had 1 or more episodes of DKA or hyperosmolar state/coma in the past 6 months.
• Cardiovascular: 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).
• Renal: have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine ≥2 milligram/deciliter (mg/dL) (177 micromole/liter [mol/L]).
• Hepatic: 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.

• Lipid-lowering medications:

  • Are using niacin preparations as a lipid-lowering medication or bile acid sequestrants within 90 days prior to screening; or,
  • Are using lipid-lowering medication at a dose that has not been stable for ≥90 days prior to screening.