A Study of LY2189102 in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY2189102; Placebo
Intervention description: Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.; Participants received 2 SC injections weekly for 12 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 106.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Diabetes; 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.