a study of ly2189102 in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: study to evaluate the safety, tolerability and efficacy of ly2189102 in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * have type 2 diabetes and confirmed by fasting c-peptide levels greater than or equal to 0.8 nanograms per milliliter \[ng/ml\]), with duration of more than 3 months. * body mass index between 25 and 40 kilograms per square meter (kg/m2). * stable on diet and exercise alone, with or without metformin monotherapy (stable regimen or dose for at least 8 weeks). * drug-naïve or previous anti-diabetic pharmacotherapy use is allowed (for the latter, patient must have stopped taking pharmacotherapy greater than 12 weeks prior to screening and only if deemed appropriate by the investigator). * angiotensin converting enzyme inhibitors, angiotensin ii receptor blockers, thiazide diuretics or calcium channel blockers are permitted for the treatment of hypertension or proteinuria. * glycated hemoglobin level between 7% and 10%. * baseline high-sensitivity c-reactive protein greater than or equal to 2 milligrams per liter (mg/l) * females of childbearing potential (not surgically sterilized and between menarche and 1 year post-menopause) must test negative for pregnancy at the time of enrollment based on a pregnancy test. furthermore, sexually active female and male participants must agree to use 2 reliable methods of birth control during the study and for 3 months following the last dose of study drug. * reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures. exclusion criteria: * current use of anti-diabetic pharmacotherapy (except metformin, under conditions specified in inclusion criteria above). * current treatment with anti-inflammatory drugs, including corticosteroids and non-steroidal anti-inflammatory drugs (100 mg per day or less of aspirin allowed). * within 60 days of the initial dose of the study drug, have received treatment with a drug that has not received regulatory approval for any indication. * presence of autoantibodies to glutamic acid decarboxylase 65 or islet-cell autoantibody-2. * evidence of tuberculosis as documented by a specific assay, medical history, and chest x-ray. a specific assay, (for example, tuberculin testing) will be conducted unless it is medically inappropriate. exceptions include patients with a history of a positive specific assay for tb who have been treated with isonicotinyl hydrazine (documented) for at least 6 months, or patients with a previous diagnosis of tb who have been appropriately treated and can provide documentation. * symptomatic herpes zoster within 3 months of randomization. * show evidence of hepatitis c and/or positive hepatitis b surface antigen. * show evidence of human immunodeficiency virus and/or positive test of antibodies to human immunodeficiency virus (hiv). * received live or attenuated vaccine(s) within the previous 3 months prior to randomization or will receive within 3 months from the end of study. * screening serum creatinine greater than 2.0 milligrams per deciliter (mg/dl). * serum aspartate aminotransferase or alanine aminotransaminase concentration greater than 2x the upper limit of normal. * known allergies to ly2189102 or excipients. * previously completed or withdrawn from this study or any other study investigating ly2189102. * have donated blood of greater than 500 ml within the preceding 30 days and intend to donate within 3 months from the end of study. * have had other recent or ongoing signs of infection (for example, fever, current treatment with antibiotics). * experienced a serious bacterial infection within 6 months of randomization. * have a serious medical illness including but not limited to any cardiovascular, hepatic, respiratory, hematological, endocrine, or neurological disease, or any clinically significant laboratory abnormality. * have had lymphoma, leukemia, or any non-breast malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease. * have had a previous reaction to other biologics that, in the opinion of the investigator, puts the patient at serious risk.

Keywords: diabetes type 2 diabetes